Category Archives: Surgery

Why hospitals are failing civilians who get PTSD

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Gunby Lois Beckett
ProPublica, March 4, 2014

More than 20 percent of civilians with traumatic injuries may develop PTSD. Trauma surgeons explain why many hospitals aren’t doing anything about it.

Undiagnosed post-traumatic stress disorder is having a major impact on injured civilians, particularly those with violent injuries, as Propublica detailed last month.

One national study of patients with traumatic injuries found that more than 20 percent of them developed PTSD.

But many hospitals still have no systematic approach to identifying patients with PTSD or helping them get treatment.

We surveyed 21 top-level trauma centers in cities with high rates of violence. The results show that trauma surgeons across the country see PTSD as a serious problem.  Continue reading

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Insurance, not Injuries, may determine who goes to trauma centers

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Sign for an emergency room.By Sarah Varney
KHN Staff Writer

FEB 20, 2014

It’s called “patient dumping” – when hospitals transfer patients without insurance to public hospitals.

But a new study from Stanford University has turned dumping on its head.

It finds that hospitals are less likely to transfer critically injured patients to trauma centers if they have health insurance.  Continue reading

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When a university hospital backs a surgical robot, controversy ensues

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DaVinci ad1By Charles Ornstein
ProPublica, Feb. 14, 2014

Flipping through the New York Times magazine a few Sundays ago, former hospital executive Paul Levy was taken aback by a full-page ad for the da Vinci robot.

It wasn’t that Levy hadn’t seen advertising before for the robot, which is used for minimally invasive surgeries. It was that the ad prominently featured a dozen members of the surgery team at the University of Illinois Hospital and Health Sciences System. “We believe in da Vinci surgery because our patients benefit,” read the ad’s headline.

“While I have become accustomed to the many da Vinci ads, I was struck by the idea that a major university health system had apparently made a business judgment that it was worthwhile to advertise outside of its territory, in a national ad in the New York Times,” Levy, former chief executive of the prestigious Beth Israel Deaconess Medical Center in Boston, told me by email.  Continue reading

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Over-the-counter pills left out of FDA acetaminophen limits

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By Jeff Gerth and T. Christian Miller
ProPublica

January 16, 2014 – Earlier this week, the U.S. Food and Drug Administration urged health care providers to stop writing prescriptions for pain relievers containing more than 325 milligrams of acetaminophen, the active ingredient in Tylenol.

The agency’s announcement was aimed primarily at popular prescription medicines that combine acetaminophen with a more powerful opioid such as hydrocodone.

Agency officials said they had determined that “there are no available data” to show that the benefits of having more than 325 milligrams of acetaminophen in a single pill outweighed the risks from taking too much of the drug. Continue reading

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Does knowing medical prices save money? California experiment says yes

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Hip replacement  - thumbBy Ankita Rao

The fact that the cost of a hip replacement can ring up as $15,000 or $100,000 — depending on the hospital — makes a lot of people uncomfortable. But that’s only if they know about the wide price tag variations.

In an effort to raise awareness and rein in what can seem like the Wild West of health care, the California Public Employees’ Retirement System (CalPERS), the second largest benefits program in the country, and Anthem Blue Cross started a “reference pricing” initiative in 2011.

The initiative involved a system to guide their enrollees to choose facilities where routine hip and knee replacement procedures cost less than $30,000.

Here’s how it works: The CalPERS program designated certain hospitals that met this cost threshold, and enrollees who chose among these facilities pay only the plan’s typical deductible and coinsurance up to the out-of-pocket maximum.

Patients who opted for other in-network hospitals were responsible for regular cost sharing and “all allowed amounts exceeding the $30,000 threshold, which are not subject to an out-of-pocket maximum,” noted the report.

The results tallied savings of $2.8 million for CalPERS, and $300,000 in patients’ cost sharing, according to research released Thursday by the Center for Studying Health System Change for the non-profit group National Institute for Health Care Reform.

Researchers found that patients who received “intensive communication” from CalPERS were supportive of the efforts and recognized lack of price transparency in the system. The report also said enrollees were satisfied with the level of care they received when choosing facilities that met their cost threshold.

But that information has yet to reach the larger population of health consumers, said Alwyn Casill, the director of public relations for the Center for Studying Health System Change.

“There is a tremendous need to increase public awareness of this problem,” she said. “It should matter to you as someone who is paying for health care, not just for you, but for everybody.”

While the report doesn’t completely detail CalPERS’ approach to reference pricing, Casill said there is optimism that it will be a model for other insurance plans and medical systems.

But that is further limited by the narrow focus of this initiative on just two kinds of procedures — others, like MRIs and CAT scans, are also vulnerable to wide pricing disparities.

Some experts say any real success on streamlining health care costs will include the ability for consumers to understand the issue and call for change.

“The numbers are dramatic,” said Julie Schoenman, director of research and quality at the National Institute For Health Care Management Foundation, a non-profit educational organization unaffiliated with the report. “I think you really do need to have good quality measures, good transparency. And a lot of patient education.”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Robot

As robot-assisted surgery expands, are patients and providers getting enough information?

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RobotBy Marissa Evans
KHN Staff Writer

The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cost.

Problems resulting from surgery using robotic equipment—including deaths—have been reported late, inaccurately or not at all to the Food and Drug Administration, according to one study.

The study, published in the Journal for Healthcare Quality earlier this year, focused on incidents involving Intuitive Surgical’s da Vinci Robotic Surgical System over nearly 12 years, scrubbing through several data bases to find troubled outcomes.

Researchers found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries. But they also found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all.

The FDA assesses and approves products based on reported device-related complications. If a medical device malfunctions, hospitals are required to report the incident to the manufacturer, which then reports it to the agency. The FDA, in turn, creates a report for its Manufacturer and User Facility Device Experience database.

The use of surgical robots has grown rapidly since it was first approved for laparoscopic surgery (a type of surgery that uses smaller incisions than in traditional surgery) by the FDA in 2000. Between 2007 and 2011 the number of da Vinci systems installed increased by 75 percent in the United States from 800 to 1,400, according to the study.

Noting that robotic surgery has promising benefits, the study also called it “essential that device related complications be uniformly captured, reported and evaluated,” so the medical community fully understands “the safety of the new technology.”

Intuitive Surgical, the makers of the da Vinci device, released a statement last monthtaking issue with the study’s findings.

“The Journal for Healthcare Quality article gives the misleading impression that Intuitive Surgical has systematically failed in its obligation to timely report known adverse events to the FDA,” the statement said. “Intuitive Surgical can only report adverse events after it becomes aware of them. We take this requirement very seriously and make every effort to account for all reportable events—even those from several years prior.”

The company said it agreed regarding the “need for a more robust and standardized system for reporting adverse events” but also encouraged the study’s authors “to conduct a comparable study that assesses the under reporting of both open and laparoscopic surgical events and would welcome a comparison with robotic-assisted surgery.”

Health care professionals say benefits to robotic surgery compared with traditional open surgery include smaller incisions, shorter hospital stays and less pain after the operation.

Dr. Martin A. Makary, an associate professor of surgery and health policy and management at John Hopkins University and one of the study’s authors,  said that, while the future for robotic surgery is promising, there is a gray area when it comes to assessing the difference between doctor and device error. And benefits from the use of the device may be inconsistent, he said.

Robotic surgery has shown benefits when it comes to head and neck surgery, he said, but there’s not necessarily a stark difference between a conventional laparoscopic or robotic-assisted surgery when it comes to gall bladder removal.

Comparing patient outcomes from conventional and robotic surgeries is important for determining which is best for patients and insurers and whether it is worth the extra cost. A study in the Journal of the American Medical Association compared robotically assisted hysterectomies with traditional laparoscopic surgeries over a three year period and found the former added an average of $2,000 in costs per procedure—nearly a third higher—with no significant clinical advantages.

Noting that information, the American Congress of Obstetricians and Gynecologists released a statement in March, advising patients that “robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.”

The ACOG statement noted that “if robotic surgery is used for all hysterectomies each year,” it would add an estimated $960 million to $1.9 billion to the annual cost of hysterectomy surgeries.

Even if better data were available through the FDA, that information might not make it to the patient.

Makary and his co-authors noted an earlier finding that “among the 37 percent of U.S. hospitals that describe robotic surgery on their hospital website, none mentioned any potential risks or complications.

“We rely on a haphazard reporting system that uses immature data and only the best experiences make it into the data,” Makary said. “We introduce things but we don’t evaluate them very well. If we’re relying on the FDA about what (products) are superior, then we need a new process…you can’t make conclusions on the safety profile of a device based on a shoddy reporting system.”

The study noted that one patient’s injury and death occurred in 2009, but no such incident was found in the FDA’s database for that year.  The authors found ”a very late report matching his case in 2010,” received by the FDA two weeks after the Wall Street Journal ran a story citing the case.

The agency issues warning letters to manufacturers who fail to meet their reporting obligations. If manufacturers still fail to report incidents, the FDA can exercise enforcement and compliance options, including product seizures or injunctions.

But the agency admits that its reporting system has limitations.

“Complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish or compare rates of event occurrence,” said FDA spokeswoman Synim Rivers in an email. “For these reasons, the FDA also evaluates other information to make decisions about a device’s safety and effectiveness once a device is on the market.”

James F. Blumstein, director of the Vanderbilt Health Policy Center and Professor of Constitutional  Law and Health Law & Policy, said with robotic surgery, for patients it’s not necessarily about knowing which procedure would be best but being fully informed of their options. He said that if there are known injuries and routine problems, health care providers need to disclose that information to patients.

“If you as a patient are going to a doctor, and they’re using a robot, it’s a question of who’s in charge,” Blumstein said. “If it’s a mechanical malfunction, would the professional standard of care apply to a robot?”

If problems occur during robotic surgery and subsequent litigation, a question might arise about whether the doctor, the hospital or the manufacturer was responsible, introducing the potential issue of product liability. But there may be protection for doctors performing robotic surgery in disclosing the risks, Blumstein said.

“If a doctor discloses to a patient there’s a comparative risk (between regular surgery and robotic surgery) and that disclosed risk materializes, I would have a hard time thinking the doctor would be considered negligent,” he said.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Jerral Hancock and Stacie Tscherny Portrait

Finally home, injured vets face new lives as VA faces costs

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By Jessica Wilde, News21

This report is part of a project on post-9/11 veterans in America produced by the Carnegie-Knight News21 program.

Jerral Hancock wakes up every night in Lancaster, Calif., around 1 a.m. dreaming he is trapped in a burning tank. He opens his eyes, but he can’t move, he can’t get out of bed and he can’t get a drink of water.

Stacie Tscherny dropped everything to take care of her son, U.S. Army veteran Jerral Hancock, when he came home from Iraq without an arm. She helps take care of his two children now as well. (Photo by Jessica Wilde/News21)

Hancock, 27, joined the Army in 2004 and went to Iraq, where he drove a tank. On Memorial Day 2007 — one month after the birth of his second child — Hancock drove over an IED. Just 21, he lost his arm and the use of both legs, and now suffers from post-traumatic stress disorder.

The Department of Veterans Affairs pays him $10,000 every month for his disability, his caretakers, health care, medications and equipment for his new life.

Jerral Hancock and Stacie Tscherny Portrait

Stacie Tscherny dropped everything to take care of her son, U.S. Army veteran Jerral Hancock, when he came home from Iraq without an arm. She helps take care of his two children now as well. (Photo by Jessica Wilde/News21)

No government agency has calculated fully the lifetime cost of health care for the large number of post-9/11 veterans of the wars in Iraq and Afghanistan with life-lasting wounds.

But it is certain to be high, with the veterans’ higher survival rates, longer tours of duty and multiple injuries, plus the anticipated cost to the VA of reducing the wait times for medical appointments and reaching veterans in rural areas.

“Medical costs peak decades later,” said Linda Bilmes, a professor in the Kennedy School of Government at Harvard University and coauthor of “The Three Trillion Dollar War: The True Cost of the Iraq Conflict.”

As veterans age, their injuries worsen over time, she said. The same long-term costs seen in previous wars are likely to be repeated to a much larger extent.

Post-9/11 veterans in 2012 cost the VA $2.8 billion of its $50.9 billion health budget for all of its annual costs, records show. And that number is expected to increase by $510 million in 2013, according to the VA budget.

Like Hancock, many veterans returning from Iraq and Afghanistan have survived multiple combat injuries because of military medicine’s highly advanced care. Doctors at Brooke Army Medical Center in San Antonio repaired Hancock’s body with skin grafts and sent him to spinal-cord doctors for the shrapnel that ultimately left him paralyzed. He still has his right arm, but he can only move the thumb on his right hand.

Injuries like Hancock’s likely will lead to other medical issues, ranging from heart disease to diabetes, for example, as post-9/11 veterans age.

“So we have the same phenomenon but to a much greater extent,” Bilmes said. “And that drives a lot of the long-term costs of the war, which we’re not looking at the moment, but which will hit in 30, 40, 50 years from now.”

Veterans like Hancock with polytraumatic injuries will require decades of costly rehabilitation, according to a 2012 Military Medicine report that analyzed the medical costs of war through 2035. More than half of Iraq and Afghanistan veterans are between the ages of 18 and 32, according to 2011 American Community Survey data. They are expected to live 50 more years, the Institute of Medicine reports.

About 25 percent of post-9/11 veterans suffer from post-traumatic stress disorder, and 7 percent have traumatic brain injury (TBI), according to Congressional Budget Office analyses of VA data. The average cost to treat them is about four to six times greater than those without these injuries, CBO reported. And polytrauma patients cost an additional 10 times more than that.

Post-9/11 veterans use the VA more than other veterans and their numbers are growing at the fastest rate. Fifty-six percent of Iraq and Afghanistan veterans use the VA now, and their numbers are expected to grow by 9.6 percent this year and another 7.2 percent next year, according to a VA report from March 2013.

Jerral Hancock Drinking Water

Hancock drove over an IED in Iraq in 2007. Hancock’s stepfather, Dirrick Benjamin, helps him take his medication. He and Hancock’s mother take care of him full time, helping him with everyday tasks like getting dressed and drinking water. (Photo by Jessica Wilde/News21)

 

In response to multiple injuries suffered by Iraq and Afghanistan veterans, the VA established its polytrauma care system in 2005, creating centers around the country where veterans are treated for multiple injuries, ranging from TBI and PTSD to amputations, hearing loss, visual impairments, spinal-cord injuries, fractures and burns.

Post-9/11 veterans make up around 90 percent of polytrauma patients, said Susan Lucht, program manager of the polytrauma center at the Southern Arizona VA Health Care System in Tucson.

Each polytrauma patient costs the VA on average $136,000 a year, according to a CBO report, using VA data from 2004 through 2009. And many of their medical issues will never go away.

One TBI patient at the Tucson center, Erik Castillo, has received speech, physical, occupational, psychological and recreational therapies for all of the paralysis, cognition and memory issues associated with injuries he received in a bomb blast in Baghdad.

But Castillo’s treatment is exactly what medical professionals and economists say could potentially be cost-saving as well as life-saving.

If the VA treats primary injuries early on and creates a community and family support system, it might be able to lower costs later, said Dr. James Geiling, Dr. Joseph Rosen and Ryan Edwards, an economist, in their 2012 Military Medicine report.

“And those are the costs that we’re trying to reduce by giving the care that we do,” said Dr. G. Alex Hishaw, a staff neurologist at the Tucson center.

Castillo has been living with TBI for nine years, and he still goes to the VA three times a week for therapy. “I’ll utilize the VA for the rest of my life,” he said.

The shrapnel that entered Castillo’s brain from a bomb in Baghdad in 2004 burned a portion of his frontal lobe, which had to be removed. Doctors told his parents that he wouldn’t survive and that if he did, he would need care for the rest of his life.

Slowly, Castillo started to re-create himself. He learned to talk again, to eat again, to move his left arm and leg. Now, he is going to college.

“We want them to graduate,” Lucht said. “But they always know that this is their foundation. This space is here. And their needs will change as they age.”

As Hancock and other post-9/11 veterans age, they will need increased medical care and will become more expensive for the VA. The injuries they have now will likely lead to more complicated and expensive medical issues. TBI, for example, may lead to greater risk of Alzheimer’s disease, psychological, physical and functional problems, and alcohol-abuse disorders.

Doctors and economists argue that today’s conversation should not only be about the primary wounds of war, but about the medical issues that are often associated with them. PTSD, for example, is often associated with smoking, substance abuse, depression, anxiety, heart disease, obesity and diabetes. Amputations are associated with obesity, cardiovascular disease, osteoarthritis, back pain and phantom limb pain.

“We should help an amputee to reduce his cholesterol and maintain his weight at age 30 to 40, rather than treating his coronary artery disease or diabetes at age 50,” Geiling, Rosen and Edwards wrote.

“Society is not yet considering the medical costs of caring for today’s veterans in 2035 — a time when they will be middle-aged, with health issues like those now seen in aging Vietnam veterans, exacerbated by comorbidities of post-traumatic stress disorder, traumatic brain injury and polytrauma,” they wrote.

Polytrauma centers have expanded across the country. But that doesn’t mean that all veterans live close enough to access them. In many parts of country, health care is hampered by distance because veterans who use the VA live far away from their closest VA hospital.

For Army Spc. Terence “Bo” Jones, it is more important that he live near his family.

U.S. Army Spc. Terence “Bo” Jones stepped on an IED in Afghanistan in 2012, and lost both of his legs. Now an outpatient at the VA polytrauma center in San Antonio, Texas, Jones is learning to walk on prostheses and drive an adapted car with only his hands. (Photo by Jessica Wilde/News21)

Jones lost both of his legs to an improvised explosive device blast in Afghanistan in 2012. Like Hancock, Jones woke up at Brooke Army Medical Center with his family by his side.

He was 21 when he stepped on the IED. It shot him 10 feet into the air and he landed in a nearby well. He doesn’t remember it, but his friends told him he was conscious and trying to climb out.

Now an outpatient at the VA polytrauma center in San Antonio, Jones is learning to walk on prosthetic legs, provided to him by the VA. The VA also provides adaptive driving equipment for his car, and he is taking driver education to learn how to drive with only his hands. One day, he hopes to get a service dog, and the VA will pay for veterinary care and equipment for the dog to help its owner.

“We can get them anything that they need,” Lucht said.

The VA provides other assistive accommodations for injured veterans — from grab bars and walk-in showers to wheelchairs and specialized seating. And a lot of veterans wear out their prosthetic limbs because they’re active, Lucht said.

When Jones finishes rehab, he plans to move home to Idaho, go to college and open his own shop doing custom cars and motorcycles. But in Idaho, Jones won’t be near a polytrauma center anymore.

One of the most rural veteran populations in the country is served by the Reno, Nev., VA hospital, said Darin Farr, the hospital’s public affairs officer. “We’re actually considered frontier,” he said.

The hospital’s patients come from as far away as 280 miles. More than 29,000 veterans are enrolled in the Reno hospital, staffed by 1,200 employees, only 40 to 50 percent of whom actually provide medical care.

Many VA hospitals fall behind in entering data from private health records or following up with patients, especially mental health patients for whom follow-up care is particularly important, according to VA Office of Inspector General reports.

The VA doesn’t always provide timely mental health evaluations for first-time patients, and existing patients often wait more than the recommended 14 days for their appointments, the OIG reported last year.

Veterans have complained for many years about long wait times to schedule appointments. “Long wait times and inadequate scheduling processes at VA medical centers have been long-standing problems that persist today,” the U.S. Government Accountability Office reported in February. Inconsistent scheduling policies, staffing, phone access and an outdated scheduling system make the problem worse.

Meanwhile, both the GAO and OIG have reported that VA’s data on wait times for medical appointments is unreliable, and some schedulers entered incorrect dates or changed them to meet performance standards.

Farr says the Reno hospital faces unique challenges that might contribute to wait times. The hospital competes with other hospitals for employees who might pay more than the government does.

“We don’t have a lot of space,” he added. The hospital schedules more than 373,000 outpatient visits and 4,200 inpatient visits every year. But it only has 64 hospital beds — 14 psychiatric, 12 ICU and only 38 for general use.

When Terence Jones finishes rehab at the polytrauma center in San Antonio, he hopes adaptive equipment will help him return to a normal life. Jerral Hancock, on the other hand, knows that he never will.

Hancock misses the adrenaline rush of life before his injury. He longs for a wheelchair that will go faster than 5 mph. He described the time he fell out of his hospital bed as exhilarating. He busted his cheek open, but he loved it.

With the $100,000 the Defense Department gave Hancock for his injuries when he was discharged, he bought two mobile homes outside Los Angeles, one for him and his two children, ages 9 and 6, and one for his mother and stepfather, who take care of him full time. Hancock supports all of them with his monthly disability check from the VA.

The VA bought him a wheelchair and put a lift into his front porch. They widened the doors in his mobile home so his wheelchair could fit in and out. They will pay for his medications and all of his medical care for the rest of his life.

When Hancock arrived at his new mobile home, he couldn’t fit his wheelchair in the front door. So he kept one wheelchair inside, and his stepdad carried him through the door and down the steps to a second wheelchair that he paid for himself. It took eight months for the VA to pay him $1,000 for the second wheelchair, and four months to put a lift into his front porch.

“I was stuck in the house for six months over this fight,” Hancock said. “I had a wheelchair upstairs and I had a wheelchair downstairs. And my caretaker carried me up and down the stairs from wheelchair to wheelchair. It was ridiculous.”

The VA also bought Hancock an $85,000 arm that he could attach to his shoulder to use. But he can’t seem to get it to work.

The VA gave Hancock $11,000 toward a car, but his mother said that doesn’t come close to the cost of a handicap-equipped vehicle. Instead, he bought a seven-passenger bus with a lift for his wheelchair.

Even with all of the money that the VA spends on Hancock’s medical and family care, he still lives in a mobile home, and his bedroom has little extra space with a hospital bed and a wheelchair in it. He can’t fit into his kids’ bedrooms. He can’t drink a glass of water on his own. And his air conditioning hardly works, even though he can’t be in the heat for too long because his burns prevent him from sweating.

Hancock’s children also have had to adjust.

“My son watched me walk off — he was going on 3 — and I jumped on a bus with a couple hundred pounds of gear,” he said. “The next time he saw me, I lost 100 pounds … I looked like a skeleton and I had tubes coming out everywhere … My daughter, this is all she knows.”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Illustration of the lungs in blue

GOP lawmakers press Sebelius to help child awaiting lung transplant

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sebelius100px

Sebelius

By Mary Agnes Carey

A child in desperate need of a lung transplant clinging to life. Long waiting lists of patients who need organs and too few donors to meet the demand.  Rules that govern who gets what life-saving organs – and when.

Department of Health and Human Services Secretary Kathleen Sebelius had to confront all those issues on Tuesday when Republican lawmakers asked her repeatedly why she would not use her authority to make sure a 10-year-old Pennsylvania girl gets a lung transplant that could save her life.

Sarah Murnaghan, who is suffering from end-stage cystic fibrosis, needs a lung transplant or will die in two to three weeks.

Current organ donation rules make her ineligible for an adult lung and there are fewer children’s lungs that come available.  She has been on a waiting list since 2011, according to published reports.

The Organ Procurement and Transplantation Network, whose duties include collecting and managing scientific data about organ donation, says that nearly 1,700 people nationwide are waiting for lung transplants.

Price

Price

Rep. Tom Price, R-Ga., drilled Sebelius about the situation during a Capitol Hill hearing on the HHS budget Tuesday. Murnaghan cannot get the transplant she needs “because of an arbitrary rule that if you’re not 12 years old, you’re not eligible to receive an adult lung,” said Price, who is a physician.  “Madam Secretary, I would urge you this week to let that lung transplant move forward … It simply takes your signature.”

Sebelius said she has spoken with the girl’s mother and “can’t imagine anything more agonizing” than what the family is going through.

Sebelius said about 40 very seriously ill people in Pennsylvania over the age of 12 also are waiting for a lung transplant, as are three other extremely sick children in the same Philadelphia hospital as Murnaghan.

“I would suggest that the rules that are in place and are reviewed on a regular basis are there because the worst of all worlds, in my mind, would be to have some individual picks who lives and who dies,” she said. “I think you’d want a process guided by medical science and medical experts.”

That answer didn’t satisify Rep. Lou Barletta, R-Pa.

“Why do we have such bullcrap around this place and we have the chance to save someone’s life. … Why wouldn’t we do this?” he asked.

While Sebelius has ordered a review of transplant rules to analyze their fairness, “a study will take over a year [and] this young lady will be dead,” Price said at the House Education and the Workforce Committee hearing.

After the hearing, Sebelius told reporters that HHS lawyers “very much disagree that there is any ability for an individual to reach in” and change the current organ rules.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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Questions arise about robotic surgery’s cost, effectiveness

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© 2009 Intuitive Surgical, Inc.

© 2009 Intuitive Surgical, Inc.

By Michelle Andrews

In the dozen years since the Da Vinci robot has been approved for surgeries in the United States, it’s been embraced by health care providers and patients alike.

Surgeons routinely use the multi-armed metal assistant to remove cancerous prostate glands and uteruses, repair heart valves and perform gastric bypass operations, among many other procedures.

Lately a key study and reports of reports of problems have raised questions about robotic surgery’s safety and cost-effectiveness, leading to a review of the Da Vinci system by the Food and Drug Administration and causing some experts to wonder whether the benefits of undergoing robot-assisted surgery may have been overstated.

At this time, health insurers generally pay for robotic surgery just as they would any other surgical procedure, and patient out-of-pocket costs are typically no different either.

That could change, some say, as more comprehensive data become available that clarifies when robotic-assisted surgery helps improve patient outcomes—and when it doesn’t.

Robotic surgery is similar to conventional laparascopic surgery, in which surgical instruments are inserted into small incisions in a patient’s torso and manipulated by the surgeon.

In robotic surgery, however, the surgeon sits at a console in the operating room and uses hand and foot controls to manipulate surgical tools attached to a robot’s arms.

Both types of surgery may result in quicker recovery times, less blood loss and pain for patients compared with traditional “open” surgeries performed through a larger incision.

Robot-assisted surgeries are generally more expensive than other methods, however, and don’t necessarily improve patient outcomes long-term.

study published in February in the Journal of the American Medical Association of more than 260,000 hysterectomy patients found that the median hospital cost for robot-assisted surgery was $8,868, compared with $6,679 for a laparascopic hysterectomy.

The study found that although patients who got robotic hysterectomies were less likely than laparscopic patients to be hospitalized for more than two days, there was no significant difference between the two groups on other measures, such as complications and blood transfusion rates.

In March, the American Congress of Obstetricians and Gynecologists released a statement that said in part, “There is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.”

The statement said that conventional laparascopic hysterectomy and a procedure performed through an opening at the top of the vagina have proven track records and were generally preferable to robotic hysterectomy. That statement, however, was assailed by other physicians who use the robot.

“Our study and the ACOG statement raise awareness that we really need to be critical. Robotic hysterectomy may not be the best procedure from a patient’s perspective,” says Jason Wright, an assistant professor of women’s health at Columbia University College of Physicians and Surgeons and the lead author of the study.

“Patients need factual information about all of their treatment options, and the evidence supports that robotic surgery has dramatically decreased the number of open hysterectomies in the U.S.,” says Angela Wonson, a spokesperson for Intuitive Surgical, the manufacturer of the Da Vinci system. “Robotic surgery is a technological advance that is enabling more women to receive minimally invasive surgery.”

A 2010 New England Journal of Medicine analysis of studies that examined 20 robot-assisted procedures found that using a robot added about 13 percent, or $3,200, to the average cost of a procedure in 2007.

The authors noted that there were no large-scale randomized trials of robot-assisted surgery and that the limited data available failed to show that robot-assisted surgery was superior to other procedures.

The lack of hard data hasn’t stopped patients, their doctors and hospitals from enthusiastically adopting robotic surgery. Nearly a quarter of hospitals offered robotic surgery in 2011, according to the American Hospital Association.

Last year, 367,000 robotic procedures were performed in the United States using da Vinci robots, according to Intuitive Surgical, a 26 percent increase over the 292,000 procedures performed the previous year.

John Bello, 48, had his cancerous prostate gland removed robotically two years ago by a surgeon at MedStar Washington Hospital Center in the District.

The Annapolis resident couldn’t be happier with the results of the surgery, which was covered without a hitch by his Blue Cross Blue Shield plan. Although many patients struggle with impotence or incontinence following prostate cancer surgery, Bello says he has not had any serious side effects from the surgery. He’s cancer free.

“Unless I see the scars … I don’t even think about it,” he says.

To date, hospitals, eager to attract patients with the technology du jour, have generally been willing to absorb the higher costs associated with robotic surgery.

But health care overhaul provisions that encourage payments to providers based on “episodes of care” rather than individual services may begin to change these practices, say experts.

“As we move away from the fee-for-service model, we’re going to discourage [procedures] that are no better than the higher priced one,” says A. Mark Fendrick, director of the Center for Value-Based Insurance Design at the University of Michigan.

“Health plans will try to incentivize the appropriate surgery, and that is especially true with the evolving payment models that reward quality outcomes,” says Susan Pisano, a spokeswoman for America’s Health Insurance Plans, a trade group.

This article was produced by Kaiser Health News with support from The SCAN Foundation.

Please send comments or ideas for future topics for the Insuring Your Health column to questions@kaiserhealthnews.org.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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C-Section rates vary widely across nation

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Courtesy of Salim Fadhley, Wikipedia

By Alvin Tran

Rates of C-section deliveries vary widely across the nation, according to the findings of a new study.

The study, published Monday in the journal Health Affairs, found that the overall rates of C-sections — the most common type of surgery in the U.S. — varied from about 7 to 70 percent  across the nation’s hospitals.

Researchers also found a wide variation in C-section deliveries even among women with lower-risk pregnancies, where rates varied from 2.4 to 36.5 percent. According to the study, cesarean deliveries are much more expensive than vaginal births.

“We were really surprised by how much variation we saw,” said Dr. Katy Kozhimannil, an assistant professor at the University of Minnesota’s School of Public Health and the study’s lead author. Kozhimannil said she and her colleagues expected the rates of cesarean births among lower-risk mothers to vary less compared to the overall rates.

The research team analyzed 2009 data from more than 1,000 hospitals in 44 states, taking patient characteristics into account as well as hospitals’ size, teaching status and geographic location.

The study’s findings suggest that small and rural hospitals showed more variability in C-section rates compared to other hospitals. Teaching hospitals, however, showed less variation in overall C-section rates.

Despite concerns about overuse of cesarean deliveries, Kozhimannil cautioned that some of these surgeries will always be necessary and researchers should be careful to not make doctors too uncomfortable about performing a cesarean.

“When you see variation in something, it could suggest overuse or either underuse. I think it’s important to look out for underuse as well,” Kozhimannil added. “Cesarean deliveries save lives and every woman who needs a cesarean delivery should have one.”

Dr. William Grobman, a spokesman for the American College of Obstetricians and Gynecologists and a professor in obstetrics and gynecology at the Feinberg School of Medicine at Northwestern University, said that it is important to “encourage deliveries that can be safely undertaken vaginally to occur and not to do unnecessary cesareans.”

In an interview, Grobman said the high number of cesarean deliveries has big consequences for health care costs and use and doctors consider different standards when weighing the procedure.

Though her study was unable to explain why the variation in cesarean deliveries exists, Kozhimannil is optimistic that future research — studies that analyze the financial and payment incentives in place for managing pregnancy care — may help answer the question.

“I think it is important to look beyond the woman and her characteristics and beyond the clinicians and their characteristics and really look at the system-level factors that are driving these variability and patterns in care,” she said.

The study makes four key recommendations, including better coordination among providers of maternity care to help reduce the need for C-sections and better data collection on the procedure.

The researchers also called for Medicaid, which funds nearly half of all U.S. births, to use its clout to help improve hospital obstetric practices.

And they suggested that new policies be implemented to empwer patients to help make decisions on their deliveries and to make data on the procedure more widely available.

“I think the fact that pregnant women cannot look up unbiased, easily available information on cesarean delivery rates in the hospitals from which they’re choosing is a problem that should be rectified,” Kozhimannil said.

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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FDA Updates Safety Recommendations for Metal-on-Metal Hip Implants

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An FDA Consumer Update

The US Food and Drug Administration has updated its safety information and recommendations to patients and health care professionals based on the agency’s current assessment of metal-on-metal hip implants, including:

  • the benefits and risks
  • the evaluation of published literature
  • the results of an FDA advisory panel meeting held in June 2012

Risk:

Implant components slide against each other during walking or running, which releases tiny metal particles. These particles may damage bone or soft tissue surrounding the implant and joint. Soft tissue damage could lead to pain, implant loosening, device failure and the need for revision surgery.

Some of the metal ions released will enter the bloodstream and travel to other parts of the body, where they may cause discomfort or illnesses.

Recommendations for People Considering a Metal-on-Metal Hip Implant

  • Be aware that every hip implant has benefits and risks.
  • Discuss your options for hip surgery with your orthopedic surgeon.

Recommendations for People With Metal-on-Metal Hip Implants

  • If you are not having any symptoms and your orthopedic surgeon believes your implant is functioning properly, continue to follow-up routinely with the surgeon every one to two years.
  • If you develop new or worsening problems, such as pain, swelling, numbness, noise (popping, grinding, clicking or squeaking of your hip) or a change in your ability to walk, contact your orthopedic surgeon right away.
  • If you experience changes in your general health, including new or worsening symptoms outside your hip, let your doctor or other health care professional know you have a metal-on-metal hip implant.

For More Information

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Osteoarthritis – from NIH MedlinePlus magazine

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From NIH MedlinePlus magazine 

What Is Osteoarthritis?

Osteoarthritis is the most common type of arthritis. People usually have joint pain and stiffness. Unlike rheumatoid arthritis, it does not affect skin tissue, the lungs, eyes, or blood vessels.

In osteoarthritis, cartilage—the hard, slippery tissue that protects the ends of bones where they meet to form a joint—wears away. The bones rub together, causing pain, swelling, and loss of motion. Over time, the joint also may lose its normal shape. Bone spurs—small deposits of bone—may grow on the edges of the joint. Also, bits of bone or cartilage can break off inside, causing more pain and damage.

Where does osteoarthritis occur?

Hands—Osteoarthritis of the hands seems to run in families. Women are more likely than men to have hand involvement. For most, it develops after menopause. Small, bony knobs may appear on the end joints (those closest to the nails) of the fingers. Fingers can become enlarged and gnarled, and may ache or be stiff and numb. The base of the thumb joint also is commonly affected.

Knees—Symptoms include stiffness, swelling, and pain. This makes it hard to walk, climb, and get in and out of chairs and bathtubs.

Hips—There is pain and stiffness of the joint itself. But sometimes pain is felt in the groin, inner thigh, buttocks, or even the knees. Osteoarthritis of the hip may limit moving and bending. This can make dressing or other daily activities a challenge.

Spine—There is stiffness and pain in the neck or lower back. In some cases, arthritis-related changes in the spine can put pressure on the nerves where they exit the spinal column. This results in weakness, tingling, or numbness of the arms and legs. In severe cases, bladder and bowel function can be affected.

Osteoarthritis Basics: The Joint and Its Parts

Joints allow movement between the bones and absorb the shock from walking or other repetitive motion. Joints are made up of:

Cartilage. A hard, slippery coating on the end of each bone.

Joint capsule. A tough membrane that encloses all the bones and other joint parts.

Synovium (sin-O-vee-um). A thin membrane inside the joint capsule that secretes synovial fluid.

Synovial fluid. A fluid that lubricates the joint and keeps the cartilage smooth and healthy.

Ligaments, tendons, and muscles. Tissues that surround the bones and joints, a llowing the joints to bend and move. Ligaments are tough, cord-like tissues that connect one bone to another. Tendons are tough fibers that connect muscles to bones. Muscles are bundles of specialized cells that, when stimulated by nerves, either relax or contract to produce movement.

A Healthy Joint

Illustration: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Illustration: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

In a healthy joint, the ends of bones are encased in smooth cartilage. Together, they are protected by a joint capsule lined with a synovial membrane that produces synovial fluid. The capsule and fluid protect the cartilage, muscles, and connective tissues.

A  Joint With Severe Arthritis

A Joint With Severe Osteoarthritis. Illustration: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

A Joint With Severe Osteoarthritis.
Illustration: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

With osteoarthritis, the cartilage wears away. Spurs grow out from the edge of the bone, and synovial fluid increases. The joint feels stiff and sore.

Fast Facts

  • Osteoarthritis is the most common type of arthritis. More common in older people, it is sometimes called degenerative joint disease.
  • Osteoarthritis most often occurs in the hands (at the ends of the fingers and thumbs), spine (neck and lower back), knees, and hips.
  • Some 27 million Americans age 25 and older have osteoarthritis.
  • Osteoarthritis is more likely in overweight people and among those with jobs that stress particular joints.
  • Exercise is one of the best treatments for osteoarthritis.
  • Before age 45, osteoarthritis is more common in men. After 45, it is more common in women.

Warning Signs of Osteoarthritis

  • Pain and stiffness in a joint after getting out of bed or sitting for long.
  • Swelling in one or more joints, especially those at the ends of the fingers (closest to the nail), thumbs, neck, lower back, knees, and hips.
  • Crunching feeling or the sound of bone rubbing on bone
  • Osteoarthritis may progress quickly, but in most people it develops gradually. It is relatively mild and interferes little with daily life in some people. Others have significant pain and disability.
  • If you feel hot or your skin turns red, or if your joint pain is accompanied by a rash, fevers, or other symptoms, you probably do not have osteoarthritis. Check with your health provider about possible other causes, such as rheumatoid arthritis.

Diagnosis

A combination of the following methods are used to diagnose osteoarthritis:

Clinical history—You will be asked when the condition started and how your symptoms have changed since. You will also describe any other medical problems you or your family may have, and any medications being taken. This helps your doctor make a diagnosis and understand the disease’s impact on you.

Physical examination—Your doctor checks your strength, reflexes, and general health. She or he also examines bothersome joints and observes your ability to walk, bend, and carry out daily activities, such as dressing.

X rays—X-rays will help determine the form of arthritis and how much damage there is, including cartilage loss, bone damage, and bone spurs.

Magnetic resonance imaging —Magnetic resonance imaging (MRI) provides high-resolution computerized images of internal body tissues. It is used if there is pain, X-rays don’t show much, or there is damage to other joint tissues.

Other tests—Your doctor may order blood tests to rule out other causes of symptoms. Fluid may also be drawn from the joint for microscopic examination to determine whether the pain is from a bacterial infection or uric acid crystals, indicating gout.

Treatment

Doctors often combine treatments to fit a patient’s needs, lifestyle, and health. Osteoarthritis treatment has four main goals: Improve joint function, keep a healthy body weight, control pain, and achieve a healthy lifestyle. Treatment plans can involve:

Exercise—Research shows that exercise can improve mood and outlook, decrease pain, increase flexibility, strengthen the heart and improve blood flow, maintain weight, and promote general physical fitness. Your doctor and/or physical therapist can recommend the exercises best for you.

Weight control—Weight loss can reduce stress on weight-bearing joints, limit further injury, and increase mobility. A healthy diet and regular exercise help reduce weight. A dietitian can help you develop healthy eating habits.

Rest and relief from stress on joints—Learn to recognize the body’s signals, and know when to stop or slow down. Regularly scheduled rest prevents pain from overexertion. Proper sleep is important for managing arthritis pain. If you have trouble sleeping, relaxation techniques, stress reduction, and biofeedback can help.

Nondrug pain relief and alternative therapies—You may find relief from:

  • Heat or cold (or a combination of both). Heat—with warm towels, hot packs, or warm bath or shower—can increase blood flow and ease pain and stiffness. Cold packs (bags of ice or frozen vegetables wrapped in a towel) can reduce inflammation, relieving pain or soreness.
  • Massage uses light stroking and/or kneading of the muscles to increase blood flow and warm the stressed joint.
  • Complementary and alternative therapies—Some people have found relief from such therapies as acupuncture. A large study supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Center for Complementary and Alternative Medicine (NCCAM) showed that acupuncture can relieve pain and improve function in knee osteoarthritis.
  • Nutritional supplements—such as glucosamine and chondroitin sulfate have been reported to improve osteoarthritis symptoms in some people.

Medications

When selecting medicines, your doctor will consider the intensity of pain, potential side effects of the medication, your medical history, and other medications you are taking. By working together, you and she or he can find the medication that best relieves your pain with the least risk of side effects.

The following medicines are commonly used to treat osteoarthritis:

Acetaminophen—A common over-the-counter pain reliever. It is often the first choice for osteoarthritis patients because of its safety and effectiveness compared to some other drugs.

NSAIDs (non-steroidal anti-inflammatory drugs)—A large class of medications for both pain and inflammation. It includes aspirin, ibuprofen, naproxen, and others. Some NSAIDs are available over the counter, while more than a dozen others are available only with a prescription. NSAIDs can have significant side effects. Anyone taking NSAIDs regularly should be monitored by a doctor.

Narcotic or central acting agents—Mild narcotic painkillers containing codeine or hydrocodone are often effective against osteoarthritis pain. But because of their potential for physical and psychological dependence, they are generally for short-term use.

Corticosteroids—Powerful anti-inflammatory hormones that may be injected into the affected joints for temporary relief. No more than four treatments per year are recommended.

Hyaluronic acid substitutes—These medications are injected to help lubricate and nourish joints. They are approved only for osteoarthritis of the knee.

Other medications—Doctors also may prescribe topical pain-relieving creams, rubs, and sprays, which are applied directly to the skin over painful joints. Because most medicines used to treat osteoarthritis have side effects, it is important to learn as much as possible about the medications you take, even the ones available without a prescription.

Surgery

For many people, surgery helps relieve the pain and disability of osteoarthritis. You may have surgery to:

  • remove loose pieces of bone and cartilage (arthroscopy)
  • reposition bones (osteotomy)
  • resurface bones (joint resurfacing).

Surgeons also may replace affected joints with artificial ones called prostheses. These can last up to 15 years or longer. The surgeon chooses the prosthesis according to the patient’s weight, sex, age, activity level, and other medical conditions.

After surgery and rehabilitation, the patient typically feels less pain and moves more easily.

No pills, yet . . .

“There are no pills yet for osteoarthritis, but we’re working on it . . . “

“There are no pills yet for osteoarthritis, but we’re working on it,” says Linda Sandell, Ph.D., professor of Orthopaedic Surgery and of Cell Biology at the Washington University School of Medicine, in St. Louis. In osteoarthritis, the soft tissue called cartilage, which cushions the knees and other joints of the body, wears away, causing pain and loss of mobility.

“It’s a huge and growing public health issue,” says Sandell, who points out that more than 50 percent of people age 65 and over have osteoarthritis. “But it is not just a disease of old age; people get it when they’re young, too.”

Under a multi-year grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), she and her colleagues are studying stem cells in specially bred mice to determine whether there is a correlation between injury and healing.

“Every person has stem cells, and some people are better at repairing than others,” Sandell observes. “We need to find the gene, or genes, for cartilage repair and osteoarthritis in these mice, and target these genes in the development of medications that could be used in humans.

“Every person has stem cells, and some people are better at repairing than others.”

“But like heart disease or obesity, osteoarthritis is a complex disease; the research is difficult and expensive, and improvements are hard to measure. We need to change its image as an inevitable result of old age. It has a molecular start, and it takes a long time to develop. People often don’t realize that their joints are degenerating until late in the process when they begin to hurt.”

Sandell says people can’t change their age but they can reduce the risks of osteoarthritis, which, in addition to genetics, include prior joint injuries and being overweight, through exercise and a healthy diet. “First,” she urges, “no more couch potato. Check with your doctor, then start walking a couple of miles a day. Use—but don’t overuse—your joints.

“Pay attention to what your body is telling you. If your cartilage is okay but your knee is inflamed, ice it,” she advises. “Keeping fit is one of the keys to delaying arthritis.”

Ongoing research

Osteoarthritis is not simply “wear and tear” in joints as people get older.

Researchers are studying:

  • Tools to detect osteoarthritis earlier
  • Genes
  • Tissue engineering—special ways to grow cartilage to replace damaged cartilage
  • Medicines to prevent, slow, or reverse joint damage
  • Complementary and alternative therapies
  • Vitamins and other supplements
  • Education to help people better manage their osteoarthritis
  • Exercise and weight loss to improve mobility and decrease pain
  • Researchers are learning about sex differences that explain why women are more susceptible than men to anterior cruciate ligament (ACL) injuries, which can lead to osteoarthritis. These include structural differences of the knee joint and thigh muscles and differences in the ways male and female athletes move. They are also developing ways to protect young female athletes from these injuries.
  • Discovery of the various genetic mutations leading to osteoarthritis could lead to new treatments.
  • Longer-lasting materials and designs that more closely mimic natural knee movement are making total joint replacements more suitable for younger, more active osteoarthritis patients.
  • Despite the benefits, African American and Asian American patients are less likely than their white counterparts to choose total knee replacement. Also, researchers have found that race is more important than socioeconomic status in these decisions. That is an important first step toward improving access to knee surgery, and to help all patients make informed decisions about their treatment.
  • Surgical advances have made hip replacements safer for older patients. This helps older patients who have other conditions that previously would not have allowed them to have the procedure.
  • Less invasive surgical approaches and preoperative exercise programs have led to decreased hospital stays and faster recovery. If adopted nationwide, they could lead to major cost savings.

Articles in NIH MedlinePlus magazine are written by professional journalists. All scientific and medical information is reviewed for accuracy by representatives of the National Institutes of Health. However, personal decisions regarding health, finance, exercise, and other matters should be made only after consultation with the reader’s physician or professional advisor. Opinions expressed herein are not necessarily those of the National Library of Medicine. Photos and other images without credit lines are provided by NIH.

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5 things to know about breast implants

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A Consumer Update for the FDA

breast implantShould I get breast implants? Are there alternatives? Will they need to be replaced?

And if you decide to get implants, there are even more questions. Saline or silicone?  What style? How much monitoring is needed?

Researching breast implants can be overwhelming and confusing. The Food and Drug Administration (FDA) has online tools available to help women sort through the information and provides questions to consider before making the decision.

Know the Basics

FDA has approved implants for increasing breast size in women, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. Implants are also approved to correct or improve the result of a previous surgery.

A number of studies have reported that a majority of breast augmentation and reconstruction patients are satisfied with the results of their surgery.

FDA has approved two types of breast implants for sale in the U.S.: saline (salt water solution)-filled and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness and shape.

Know the Risks

Silicone implants sold in the U.S. are made with medical-grade silicone.  These implants undergo extensive testing to establish reasonable assurance of safety and effectiveness. Nonetheless, there are risks associated with all breast implants, including:

  • additional surgeries
  • capsular contracture—scar tissue that squeezes the implant
  • breast pain
  • rupture (tears or holes in the shell) with deflation of saline-filled implants
  • silent (without symptoms) rupture of silicone gel-filled implants

FDA experts suggest five things women should know about breast implants.

1. Breast implants are not lifetime devices.

The longer a woman has them, the greater the chances that she will develop complications, some of which will require more surgery.  The patient can also request additional surgeries to modify the aesthetic outcome, such as size or shape.

“The life of these devices varies according to the individual,” says Gretchen Burns, a nurse consultant at FDA’s Center for Devices and Radiological Health (CDRH).  “All women with implants will face additional surgeries—no one can tell them when.” While a few women have kept their original implants for 20-30 years, “that is not the common experience.”

2. Research products.

Review the patient labeling. FDA advises that women look at the Summary of Safety and Effectiveness Data (SSED) for each implant to learn about their characteristics and the fillers used. SSEDs have been produced for all approved saline and silicone gel-filled breast implants. These summaries provide information on the indications for use, risks, warnings, precautions, and studies associated with FDA approval of the device. Look at the frequency of serious complications found in the SSED. The most serious are “those that lead to further surgeries, such as ruptures or capsular contracture,” says Tajanay Ki, a biomedical engineer in CDRH.

FDA advises health care providers to give women the full labeling—all of the patient information from the manufacturer—for an implant. Ask your surgeon for the most recent version of the labeling. You should have at least 1-2 weeks to review the information before making a decision, but with some reconstruction or revision surgery cases, it may be advisable to perform surgery sooner.

3. Communicate with the surgeon.

Surgeons must evaluate the shape, size, surface texture and placement of the implant and the incision site for each woman. Ask the surgeon questions about his or her professional experience, the surgical procedure, and the ways the implant might affect an individual’s life.

Also, tell the surgeon about previous surgeries and your body’s response—for example, whether surgeries resulted in excessive scar tissue—and discuss your expectations. This helps the surgeon make operative decisions that achieve the desired appearance (i.e., incision location and size, implant size and placement).  Many women undergo reoperation to change implant size.  To achieve optimal results after the first procedure, careful planning and reasonable expectations are necessary.

4. Learn about long-term risks. 

Some women with breast implants have experienced connective tissue diseases, lactation difficulties or reproductive problems. However, current evidence does not support an association between breast implants and these conditions. FDA has identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. Women who have breast implants may have a very small but increased risk of developing ALCL in the fluid or scar tissue surrounding the implant. Like other lymphomas, ALCL is a cancer of the immune system and not of breast tissue.

5. Monitoring is crucial. 

FDA recommends that women with breast implants:

  • promptly report any unusual signs or symptoms to their health care providers, and
  • report any serious side effects to MedWatch, FDA’s safety information and adverse event reporting program.

Furthermore, women with silicone implants should get MRI screenings to detect silent ruptures three years after their surgery and every two years after that.  Insurance may not cover these screenings.

Burns recommends that women with breast implants continue to perform self-examinations and get mammograms to look for early signs of cancer. “Just because you have implants doesn’t mean you can ignore other breast health recommendations,” she says.

FDA’s Online Resources

FDA has a breast implants web page (www.fda.gov/breastimplants) with resources that include:

  • Links to patient information and data for each product.
  • Information about risks and complications
  • Questions to ask health care professionals regarding breast implant surgery
  • Contact information for manufacturers of FDA-approved breast implants and related professional organizations

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

February 20, 2013

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Reviving research into US gun violence – BMJ feature

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This article by LocalHealthGuide editor Michael McCarthy, MD first appeared on the BMJ’s website and is republished here with the journal’s permission. 

Michael McCarthy looks at whether events at Sandy Hook Elementary School are paving the way to reopen research into guns

GunIn January, in response to the shooting at the Sandy Hook Elementary School in Newtown, Connecticut, that left 20 schoolchildren and six adults dead, US president Barack Obama issued 23 executive orders to deal with gun violence in America.1

Among those was an order directing the US Centers for Disease Control and Prevention (CDC) to research the causes and prevention of gun violence, an order directing the US Attorney General to issue a report on new gun safety technology, and an order clarifying that the Patient Protection and Affordable Care Act, the president’s 2010 health reform law, “does not prohibit doctors asking their patients about guns in their homes.”

That it was necessary for the president to issue executive orders directing actions in a country that sees more than 31 000 killed from gunshot wounds each year surprised many.

But for 17 years, legislation has been on the books banning or severely constraining government initiatives to reduce gun violence and gun related injuries.

In his statement announcing his executive actions, Obama denounced in particular efforts to deny federal funding for scientific and medical research into the causes of gun violence. “We don’t benefit from ignorance. We don’t benefit from not knowing the science of this epidemic of violence,” Obama said.

For much of the 20th century, gun violence in the US had been considered a law enforcement issue. But in the late 1970s and early 1980s, a series of reports and workshops started to recast the issue as a public health problem and calling for a far broader societal approach.

The 1979 US surgeon general report, Healthy People, identified homicide as a important health problem.2 The report noted that although many factors were involved in the nation’s high murder rate, including economic deprivation, family breakup, and the glamorization of violence in the media, “Easy access to firearms appears to be the one factor with a striking relationship to murder.” And in 1985 the Institute of Medicine issued an influential report, Injury in America, calling on, among other initiatives, research into the effectiveness of laws and “other measures to reduce firearm homicide.”3

As part of this shift to a public health approach to violence reduction, the CDC created a Division of Violence Prevention in 1991 and a year later raised the division to center status as the National Center for Injury Prevention and Control (NCIPC).

Gun rights advocates, however, denounced the research coming out of the center and other research groups looking in to gun related injuries, which they charged was merely anti-gun propaganda designed to demonize guns.

Research funded by the CDC that particularly angered gun rights groups were reported in two papers in the New England Journal of Medicine in 1992 and 1993.45

In those papers, Arthur Kellermann and colleagues found that keeping a gun in the home was associated with a 2.7-fold increase risk of homicide for members of the household and a 4.8-fold increase in risk of suicide.

“Despite the widely held belief that guns are effective for protection, our results suggest that they actually posed a substantial threat to members of the household,” they wrote.

In 1995, gun rights advocates, led by the National Rifle Association, enlisted their supporters in Congress to pass legislation that would have eliminated NCIPC completely.

When that effort failed, they instead successfully stripped the CDC of the $2.6m (£1.7m; €1.9m) of its budget slated for gun violence research and forbid the agency “to advocate or promote gun control.”

Similar language was put in legislation governing the National Institutes of Health’s budget, and federal funding for public health research into gun violence all but disappeared.

Gun rights advocates also moved to pass both state and federal laws seeking to prevent doctors from asking their patients about guns in their homes.

Several medical societies, including the American Academy of Pediatrics, the American College of Physicians, and the Academy of Family Physicians, have recommended that physicians counsel their patients about firearm injury prevention, such as the use of gun safes and trigger locks.

Florida passed a law that made it possible to sanction doctors who held such conversations and recorded information about gun ownership in a patient’s medical record.

During the battle over the health reform law, Senator Harry Reid, the Senate Majority Leader and a Democrat from the rural state of Nevada, inserted a provision mandating that the wellness and health promotion activities implemented by the law “may not require the disclosure or collection of any information relating to . . . the presence or storage of a lawfully possessed firearm or ammunition in the residence or on the property of an individual; or . . . the lawful use, possession, or storage of a firearm or ammunition by an individual.”

Michael Hammond, legal counsel for the Gun Owners of America, a gun rights advocacy group which pushed for the provision, said his organization had two main concerns. Firstly, that gun ownership documented in electronic medical records would turn into a “de facto national gun registry.” Such a registry is an anathema to gun rights advocates who see gun registration as a first step towards confiscation.

The second concern, Hammond said, was that the presence of a gun in the home would be used by insurance companies to raise insurance premiums to the point that gun ownership would become prohibitively expensive.

Just as cigarette taxes are being used to discourage smoking, Hammond said, the price of health insurance, which everyone must purchase under the new health reform law could be used to discourage gun ownership.

“You can say that’s a good thing in respect to cigarettes, but we didn’t want the same thing to happen with respect to guns,” Hammond said.

Therese Richmond, a professor of nursing at the University of Pennsylvania and co-founder of the university’s Firearm and Injury Center, said such concerns are misplaced.

Much can be done to reduce deaths and injury from firearms without confiscating guns by adopting the same public health approaches that dramatically reduced motor-vehicle deaths in the 1970s and 80s, she said.

“We didn’t say cars are killing people; we didn’t say get rid of cars,” Richmond said, instead, public health approaches were used to change social norms around drinking and driving and seat-belt use and to improve car and road design. “Have we totally wiped put injury and death in the form of car crashes. No, but we have made significant inroads. Why can’t we take that model and do that with gun violence?’

Despite the president’s executive orders, the future of research into gun violence and gun-related injury prevention remains uncertain, says Kellermann, the lead author of the New England Journal of Medicine papers who is now chair in policy analysis at the RAND Corporation. One concern is that there is no guarantee Congress will provide the funding for the research, he said. The other concern is whether there will be enough researchers willing to do the work that’s needed.

“There were never large numbers of researchers active on this issue. You could almost count the public health community working on this topic on both hands without having to go to your toes,” Kellermann said. “What we don’t know is are there young or early-career medical and public health researchers who will rise to this challenge and be willing to take on work that could easily disappear as quickly as it re-emerges, particularly if Congress chooses not to take action.”

Kellermann also believes that it is possible to take public health approaches to “lower burden of mortality and morbidity from gun violence without compromising the safe, reasonable ownership, use and enjoyment of firearms.”

“But to do that we have to set the politics aside, try to understand the phenomenon much better and make smart choices as individuals and society,” he said.

Notes

Cite this as: BMJ 2013;346:f980

Footnotes

  • Competing interests: I have read and understood the BMJ Group policy on declaration of interests and have no relevant interests to declare.
  • Provenance and peer review: commissioned, not peer reviewed.
  • Editorial: Common sense gun policy reforms for the United States, doi:10.1136/bmj.e8672.
  • Blog: Get the gun out of the house, http://bit.ly/12k2V7U.
  • Blog: Krishna Chinthapalli on the questions around gun control in the US,http://bit.ly/Tv2i6I.

References

  1. Remarks by the President and Vice President on Gun Violence. January 16, 2013 www.whitehouse.gov/the-press-office/2013/01/16/remarks-president-and-vice-president-gun-violence.
  2. United States Public Health Service. Healthy people: the surgeon general’s report on health promotion and disease prevention. Publication no 79-55071. http://profiles.nlm.nih.gov/NN/B/B/G/K/.
  3. National Academy of Sciences. Injury in America: a continuing public health problem. Washington: National Academy Press; 1985. www.nap.edu/catalog.php?record_id=609.
  4. Kellermann AL, Rivara FP, Somes G, Reay DT, Francisco J, Banton JG, Prodzinski J, Fligner C, Hackman BB. Suicide in the home in relation to gun ownership. N Engl J Med1992;327:467-72. http://www.nejm.org/doi/full/10.1056/NEJM199208133270705.
  5. Kellermann AL, Rivara FP, Rushforth NB, Banton JG, Reay DT, Francisco JT, Locci AB, Prodzinski J, Hackman BB, Somes G. Gun ownership as a risk factor for homicide in the home. N Engl J Med1993;329:1084-91. http://www.nejm.org/doi/full/10.1056/NEJM199310073291506.
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Hip replacement  - thumb

Need a price for a hip replacement? Good luck with that . . .

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Hip replacement  - thumbBy Scott Hensley, NPR News
This story comes from our partner ‘s Shots blog.

Let’s say your 62-year-old granny is feeling creaky. One of her hips has been giving her trouble, and her doctor tells her it’s time to get it replaced with an implant.

There’s a catch. Grandma isn’t old enough for Medicare and she doesn’t have health insurance. She does, however, have a stack of cash in the bank and is willing to pay for surgery right away.

So how much will it cost her?

Who knows. Seriously.

Researchers from Iowa called 20 top-rated orthopedic hospitals across the country using a script based on Grandma’s predicament. They asked for the lowest price (everything included) for a total hip replacement.

The researchers also asked two other hospitals in each state and Washington, D.C., for good measure.

Getting an answer wasn’t easy.

Of the top 20 hospitals, only 9, or 45 percent, provided a bundled price that included fees for both the doctors and the facilities.

But that response looks terrific compared with how the other hospitals did.

The researchers were able to get a bundled price estimate from only 10, or about 10 percent, of the other 102 hospitals they queried.

The researchers were able to piece together prices in quite a few instances by contacting doctor groups when hospitals provided only their fees.

Even after incorporating those figures, however, total pricing information was available for only 60 percent of the top hospitals and 63 percent of the others.

The prices obtained varied widely: from a low of $11,100 to more than $125,000.

The findings were just published online by JAMA Internal Medicine.

Why couldn’t more hospitals comply? Some said a doctor would need to see a patient before an estimate could be given. Others said they didn’t give out prices over the phone. Some just said there was no way they could do it.

“Our calls to hospitals were often greeted by uncertainty and confusion by the hospital representatives about how to assist us,” the researchers wrote. “It is sobering to compare our experience with the best practices we have come to expect from other service industries.”

Buying a car used to be like this, an accompanying editorial points out: “A 2013 hip replacement looks a lot like a 1954 Buick.” But a 1958 federal law that required dealers to post sticker prices on vehicles began a long road to fuller disclosure about prices and specifications that have changed the marketplace for automobiles.

Now it’s time for hospitals and doctors to do a better job, the authors of the editorial write. “There is no justification for the inability to report a fee estimate, or a 12-fold price variation for a common elective procedure,” they declare.

As a matter of fact, they argue, the health care business is even worse off than the car business was. Many doctors and hospitals don’t know the price of their products, unlike car dealers.

Still, there’s hope, the editorialists say.

“The history of the automobile industry shows that information asymmetry is treatable,” they write. “Health care will need to travel down a similar path. It is time we stop forcing people to buy health care services blindfolded — and then blame them for not seeing.”

This article was reprinted from kaiserhealthnews.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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