Category Archives: Surgery

Contraceptive implant under microscope amid questions of safety, altered trial data

Portrait of Kimberly Lira at her home in Peoria, Az.

Portrait of Kimberly Lira at her home in Peoria, Az. (Photo by Nick Oza for KHN)

By Roni Caryn Rabin

Kim Hudak was a young mother who was done having children when she volunteered for a clinical trial to an experimental birth control implant designed to make her sterile without tube tying surgery.

But soon after Hudak, 28 at the time, got the Essure implants in 2000, she said she developed health problems, including severe pelvic and lower back pain, difficult menstrual periods and pain during intercourse.

She complained to researchers at the Cleveland Clinic and was told her problems were not related to the implant. In an affidavit to the Food and Drug Administration, Hudak alleges that answers she gave researchers in response to questions about pain, adverse health effects and even whether her period was late had been altered on her medical record, without her knowledge. Those statements were part of the usual data collection for FDA approval of the device.

“I realized something could go wrong in a clinical trial, but I thought they would take care of me, and that if something wasn’t right, they’d fix it,” said Hudak, who eventually had a hysterectomy to remove the implants in 2013 and has filed a claim against Essure’s manufacturer for compensation for her injuries.

Hudak is one of several clinical trial participants who say that when they experienced complications with the implant, doctors and nurses ignored or belittled their symptoms, insisted they could not possibly have been caused by Essure, and referred them elsewhere for treatment. Continue reading


New heart procedure boon to patients and hospitals

Dr. Josh Rovin, left, and Dr. Douglas Spriggs, right, perform TAVR procedure at Morton Plant Hospital in Clearwater, Florida (Photo by Phil Galewitz/KHN)

Dr. Josh Rovin, left, and Dr. Douglas Spriggs, right, perform TAVR procedure at Morton Plant Hospital in Clearwater, Florida (Photo by Phil Galewitz/KHN)

New Hope Beats For Heart Patients And Hospitals

By Phil Galewitz

CLEARWATER, Fla. – Inch by inch, two doctors working side by side in an operating room guide a long narrow tube through a patient’s femoral artery, from his groin into his beating heart. They often look intently, not down at the 81-year-old patient, but up at a 60-inch monitor above him that’s streaming pictures of his heart made from X-rays and sound waves.

As with other new medical technology, TAVR draws concerns about possible overuse or adoption by hospitals lacking proficiency, which could harm patients and increase health care costs.

The big moment comes 40 minutes into the procedure at Morton Plant Hospital. Dr. Joshua Rovin unfurls from the catheter a metal stent containing a new aortic valve that is made partly out of a pig’s heart and expands to the width of a quarter outside the catheter. The monitor shows it fits well over the old one. Blood flow is normal again.  “This is pretty glorious,” Rovin said.

The surgeon has performed one of the fastest-growing procedures in U.S. heart care known as a transcatheter aortic valve replacement, or TAVR. The operation was approved in the U.S. in late 2011 to help patients too ill or frail for traditional “open-heart” valve surgery. The procedure has rapidly gained doctors’ acceptance, particularly for patients in their 80s and 90s. Continue reading


Is a double knee replacement right for you?


Having both knees replaced at the same time has advantages

By Dr. David Kieras
Virginia Mason

samIf someone you know has severe arthritis in both knees that greatly reduces their quality of life, they may be a candidate for bilateral simultaneous knee replacement surgery, where both joints are simultaneously operated on in one surgical procedure.

Although not an option for everyone, this approach is enticing to many people who dread the idea of recovering from two separate surgeries, which delays recovery and a return to normal activities for several months, if not years.

Bilateral ‘staged’ knee replacement – one knee surgery followed by another – is not uncommon.  However, bilateral simultaneous knee replacement is more advanced and uncommon due to the special expertise and team coordination required.

It can be beneficial for people who have limited time off from work for rehabilitation and need to return to a more normal lifestyle as quickly as possible. Continue reading


Online scorecard helps you pick a surgeon


surgeons performing surgery in operating roomThe independent investigative journalism website ProPublica has created online “Surgeon Scorecard” that you can use to find out a surgeon’s complication rate for eight commonly performed operations.

To learn about the complication rates of surgeons working at hospitals in Washington state go here.


Do cell phones belong in the OR?


Next time you’re on the operating table and you have one last look around as the anesthesiologist approaches, don’t be too sure that that person in scrubs looking at a smartphone is pulling up vital health data.

He or she might be texting a friend, or ordering a new carpet.

Cellphone use is not generally restricted in the operating room, but some experts say the time for rules has come. In interviews, many described co-workers’ texting friends and relatives from the surgical suite. Some spoke of colleagues who hide a phone in a drawer and check it when they think no one is watching.

Cellphone use is not generally restricted in the operating room, but some experts say the time for rules has come.

“Sometimes it’s just stuff like shopping online or checking Facebook,” said Dwight Burney, an orthopedic surgeon from Albuquerque. “The problem is that it does lead to distraction.” This can result in medical errors or lax safety procedures, such as forgetting to check a patient’s identity, he said.

In one 2011 incident, a Texas anesthesiologist was accused of sending text messages and e-mails while monitoring a patient. Her oxygen levels dropped, which the anesthesiologist allegedly didn’t notice for close to 20 minutes, and she died in surgery. The woman’s family sued the anesthesiologist. The case was settled before going to trial. Continue reading


Boston bombing survivors struggle with medical and emotional recovery


Map of BostonBy Martha Bebinger, WBUR

It’s just the crumb of a muffin but Martha Galvis must pick it up. Lips clenched, eyes narrowed, she goes after the morsel, pushing it back and forth, then in circles, across a slick table top.

“I struggle and struggle until,” Galvis pauses, concentrating all her attention on the thumb and middle finger of her left hand. She can’t get them to close. “I try as much as I can. And if I do it I’m so happy, so happy,” she says, giggling.

Martha Galvis has undergone 16 surgeries for her hand, which was injured in the Boston Marathon bombing. (Jesse Costa/WBUR)

Martha Galvis has undergone 16 surgeries for her hand, which was injured in the Boston Marathon bombing. (Jesse Costa/WBUR)

Galvis, 62, has just finished a session of physical therapy at Brigham and Women’s Faulkner Hospital where she goes twice a week.She’s learning to use a hand doctors are still reconstructing.

It’s been two years since she almost lost it.

On April 15th, 2013 Martha and her husband Alvaro Galvis headed for three spots from which they’d enjoy the race and boisterous crowd. Their last stop would be at or near the finish line.

Watching the marathon was a ritual that began in the mid 1970s when the Galvises, who are both from Columbia, met in Boston. Their three children grew up with the marathon as family holiday. The Galvises planned to continue the annual event after retirement.

“But not anymore,” says Martha Galvis, waving both hands in front of her face. “I don’t feel secure to do this.” Continue reading


Attention, shoppers: Prices for 70 health care procedures now online!


By Jay Hancock

Buying health care in America is like shopping blindfolded at Macy’s and getting the bill months after you leave the store, economist Uwe Reinhardt likes to say.

A tool that went online Wednesday is supposed to give patients a small peek at the products and prices before they open their wallets.

Got a sore knee? Having a baby? Need a primary-care doctor? Shopping for an MRI scan? shows the average local cost for 70 common diagnoses and medical tests in most states. That’s the real cost — not “charges” that often get marked down — based on a giant database of what insurance companies actually pay.

OK, this isn’t like for knee replacements. What Guroo hopes to do for consumers is limited so far. Demo from Health Care Cost Institute on Vimeo.

It won’t reflect costs for particular hospitals or doctors, although officials say that’s coming for some. And it doesn’t have much to say initially about the quality of care.

Still, Guroo should shed new light on the country’s opaque, complex and maddening medical bazaar, say consumer advocates.

“This has the potential to be a game-changer,” said Katherine Hempstead, who analyzes health insurance for the Robert Wood Johnson Foundation. “It’s good for uninsured people. It’s good for people with high deductibles. It’s good for any person that’s kind of wondering: If I go to see the doctor for such-and-such, what might happen next?” Continue reading


How safe are outpatient surgery centers?


Popularity Of Outpatient Surgery Centers Leads To Questions About Safety

Woman_doctor_surgeonBy By Sandra G. Boodman
KHN and Washington Post

Wendy Salo was alarmed when she learned where her doctor had scheduled her gynecologic operation: at an outpatient surgery center.

“My first thought was ‘Am I not important enough to go to a real hospital?’ ” recalled Salo, 48, a supermarket department manager who said she felt “very trepidatious” about having her ovaries removed outside a hospital.

Before the Sept. 30 procedure, Salo drove 20 miles from her home in Germantown, Md., to the Massachusetts Avenue Surgery Center in Bethesda for a tour. Her fears were allayed, she said, by the facility’s cleanliness and its empathic staff.

Salo later joked that the main difference between the multi-specialty center and Shady Grove Adventist Hospital — where she underwent breast cancer surgery last year — was that the former had “better parking.”

Salo’s initial concerns mirror questions about the safety of outpatient surgery centers that have mushroomed since the highly publicized death of Joan Rivers.

The 81-year-old comedian died Sept. 4 after suffering brain damage while undergoing routine throat procedures at Yorkville Endoscopy, a year-old free-standing center located in Manhattan.

Federal officials who investigated Rivers’ death, which has been classified by the medical examiner as a “therapeutic complication,” found numerous violations at the accredited clinic, including:

  • a failure to notice or take action to correct Rivers’ deteriorating vital signs for 15 minutes;
  • a discrepancy in the medical record about the amount of anesthesia she received;
  • an apparent failure to weigh Rivers, a critical factor in calculating an anesthesia dose;
  • and the performance of a procedure to which Rivers had not given written consent.

In addition, one of the procedures was performed by a doctor who was not credentialed by the center.

Continue reading


Whoa! Before you give the kid the keys to the car . . .


You’ve been protecting your kids their whole lives. So don’t just hand them the keys to a two-ton machine with no rules… Talk it out. Tell your teenagers they have to agree to 5 rules to drive:

  1. No cell phones,
  2. No extra passengers,
  3. No speeding,
  4. No alcohol, and
  5. Buckle-up.

Set the rules before they hit the road.

Learn more here.


Pressure from providers leads some women to have C-sections, inductions


Blue Pregnant BellyBy Christen Brownlee
Health Behavior News Service

Pregnant women who felt pressured to have a labor induction or cesarean section by their obstetrical care providers were significantly more likely to have these procedures, even if there was no medical need for them, suggests a new study in the journal Health Services Research.

Both cesarean deliveries and labor inductions continue to rise, accounting for about a third of births in the U.S.

While both procedures can be life saving for mothers and babies, previous studies have found that they can also increase the risk of poor health outcomes, such as respiratory problems for newborns and infections and death for mothers, as well as significantly increasing health care costs. Continue reading


A new look at why surgical rates vary


surgeons performing surgery in operating roomBy Michael Ollove

Several years ago, a California study showed that a half-dozen elective surgeries were being performed far more often in Humboldt County than they were in the rest of the state.

The procedures included hip and knee replacements, hysterectomies and carotid endarterectomies, a surgery to remove plaque buildup in the carotid arteries.

Geographical variation in the delivery of health care can harm patients and increase costs. That is especially true when it comes to surgery, which is usually more expensive and riskier than less invasive treatments.

Medicaid makes up a huge portion of state budgets, so the issue of health care variation is a pressing one for states looking to hold down costs.

In Humboldt County, doctors, hospitals, and others involved in health care wondered why surgeons in their area operated so often, and if they could do anything to get closer to the state norms.

To find out, they launched the Humboldt County Surgical Rate Project, which brought together doctors, health-care advocates, community organizations, unions, colleges and small employers.

As it turned out, a large part of “what was actually happening out there” was surprisingly simple . . .

“We weren’t trying to identify anyone as a ‘bad guy,’” said Betsy Stapleton, a retired nurse practitioner who is the co-director of the Humboldt County Surgical Rate Project. “The idea was to identify what was actually happening out there and to figure out ways to address it. It led to really fascinating conversations.”

As it turned out, a large part of “what was actually happening out there” was surprisingly simple: Patients in Humboldt County weren’t playing a big enough part in their own health care decisions. Continue reading


Seeking cheaper care, patients take online bids from doctors


This KHN story also ran in wapo.

Francisco Velazco couldn’t wait any longer. For several years, the 35-year-old Seattle handyman had searched for an orthopedic surgeon who would reconstruct the torn ligament in his knee for a price he could afford.

Out of work because of the pain and unable to scrape together $15,000 – the cheapest option he could find in Seattle – Velazco turned to an unconventional and controversial option: an online medical auction site called Medibid, which largely operates outside the confines of traditional health insurance.

The four-year-old online service links patients seeking non-emergency care with doctors and facilities that offer it, much the way Priceline unites travelers and hotels. Continue reading