Category Archives: Blood Disorders

Congressional leaders ask FDA about Coumadin safety


RedBloodCellsBy Charles Ornstein

The bipartisan leadership of the House Energy and Commerce Committee is asking the Food and Drug Administration how it monitors the safety of the popular blood thinner Coumadin, particularly in light of deaths and hospitalizations of nursing home residents taking the drug.

The committee’s letter, sent last week, follows a ProPublica report co-published by the Washington Post in July that focused on the harm caused by nursing homes’ failure to manage the drug.

Our analysis of government inspection reports found that, between 2011 and 2014, at least 165 nursing home residents were hospitalized or died after errors involving Coumadin or its generic version, warfarin.

In some cases, homes gave residents too much of the drug, which caused internal bleeding. In other cases, they gave residents too little, leading to blood clots and strokes. Continue reading


Feds call from more scrutiny of Coumadin use in nursing homes


Inspectors are being asked to pay greater attention following analysis showing mistakes resulting in injuries and deaths

RedBloodCellsBy Charles Ornstein
ProPublica, Aug. 3, 2015
This story was co-published with The Washington Post.

The federal government is asking health inspectors nationwide to be on the lookout for errors by nursing homes in managing the blood thinner Coumadin, including those that lead to patient hospitalizations and deaths.

In a memo sent last month to state health departments, the Centers for Medicare and Medicaid Services cited a report by ProPublica and The Washington Post that focused on the harm caused by homes’ failure to manage the drug.

In some cases, homes gave residents too much of the drug, which caused internal bleeding. In other cases, they gave residents too little, leading to blood clots and strokes.

The analysis of government inspection reports found that, between 2011 and 2014, at least 165 nursing home residents were hospitalized or died after errors involving Coumadin or its generic version, warfarin.

In some cases, homes gave residents too much of the drug, which caused internal bleeding. In other cases, they gave residents too little, leading to blood clots and strokes. Continue reading


Lead-warning for children’s herbal cold and flu remedy from China


From the Washington Department of Health

The U.S. Food and Drug Administration (FDA) has sent out an alert regarding Bo-Ying Compound after traces of lead were found in the product. Bo-Ying Compound is used to treat a wide variety of conditions in infants and children.

boying (1)

The Washington State Department of Health received an alert regarding lead found in Bo-Ying Compound manufactured by Eu Yan Sang (Hong Kong).

This product is also manufactured by other companies and may also contain lead so people are urged not to use any Bo-Ying Compound products. Continue reading


Stop the Clot, Spread the Word


By W. Craig Cooper, PhD,
Acting Director, Division of Blood Disorders, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention

Even though the risk for blood clots may not concern you yet, they are serious and they occur frequently. Estimates are about 900,000 people a year get serious blood clots and of those, about 100,000 people die from them. On average, that’s one person dying from a blood clot about every 6 minutes.

Blood clots occur most often in the legs, but can occur in the arms as well. If the clot breaks off and travels to  your lungs, this is serious. Most blood clots are preventable. That’s why the Centers for Disease Control and Prevention (CDC) is working with the National Blood Clot Alliance to make sure that the warning signs, risk factors, and what to do if this happens to you or a loved one are well known. Continue reading


Immune system shaped by environment more than genes, twin study suggests


Diagram_of_a_white_blood_cell_CRUK_028 Cancer Research UK / Wikimedia Commons / CC license

By Carol Torgan, Ph.D.
For NIH Research Matters

The immune system is a complex network of cells, tissues, and organs that work together to protect our bodies from infection.

The system must fight off invading microbes, infected cells, and tumors while ignoring healthy tissues.

There can be significant variation in immune system function between people. It’s not known how much of the variation is caused by genetic differences (heritable) and how much is due to exposure to environmental (non-heritable) factors such as microbes.

To determine the basis of immune system variation, a team led by Dr. Mark M. Davis at Stanford University School of Medicine applied the most recent advances in immune monitoring technologies to a classic research model: studying twin pairs.

The study was funded in part by NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Results appeared in Cell on January 15, 2015.

Blood samples from healthy twins helped reveal how the environment affects the immune system.

In twin studies, researchers compare identical (monozygotic) twins, who share almost all of their genes, with fraternal (dizygotic) twins, who share about half of their genes. T

win pairs share the same prenatal environment and usually have a similar childhood environment. Thus if identical twins show more similarity on a given trait compared to fraternal twins, it suggests that genes significantly influence that trait.
[tweet “Blood samples from healthy twins helped reveal how the environment affects the immune system.”]
Continue reading


Cord Blood: What You Need to Know – FDA


Consumer Update from the US Food and Drug Administration

RedBloodCellsCord blood is found in the blood vessels of the placenta and the umbilical cord, cord blood is collected after a baby is born and after the umbilical cord is cut—an important point.

“Because cord blood is typically collected after the baby is delivered and the cord is cut, the procedure is generally safe for the mother and baby,” explains Keith Wonnacott, Ph.D., Chief of the Cellular Therapies Branch in FDA’s Office of Cellular, Tissue, and Gene Therapies. Continue reading


Blood donors needed


RedBloodCellsThe American Red Cross says it faces a looming blood shortage, leading to an urgent need for donors of all blood types to roll up a sleeve and give.

Nationally, donations are down approximately 8 percent over the last 11 weeks, resulting in about 80,000 fewer donations than expected, the Red Cross Reports.

Last week Puget Sound Blood Center issued an appeal for donors after collections began to dip sharply as a result of the ongoing heat wave. During the past week, over a half dozen blood drives were suspended or cancelled as temperatures soared.

Continue reading


Puget Sound Blood Center hosts 10th annual ‘Faces For Life’ fundraiser


Puget Sound Blood Center logoBy Katherine Loh
UW News Lab

“I say the blood center is almost like the FBI where you don’t hear about it very often and in the end it’s probably a good thing, because if we were in the front pages or the headline, it may be because we screwed something up,” said Michael Cheever, director of Development for the ‘Faces for Life’ event held by the Puget Sound Blood Center (PSBC).

The PSBC hosted its annual fundraiser gala and silent auction, ‘Faces for Life,’ on Saturday evening, April 27 at the Bellevue Hyatt Regency. Cheever oversees many of the mechanics of the event and while it may sometimes be a challenge, he is glad to be a part of it.

“We can’t be more grateful for the patients that are coming out and baring their souls to speak,” Cheever said. “Through those stories, we use it to educate people that we are more than just your typical blood bank.”

Beth Newman, an emergency room nurse in her late 30s, was on her way to work when she was t-boned by a speeding van. She is a ‘face’ for blood donors after surviving a large amount of internal damage. Gary Arvan is another ‘face’ featured for organ transplant after receiving a new liver. The third ‘face’ featured was a patient’s family in support for pediatric leukemia after their 10-year-old daughter collapsed and underwent treatment for chemotherapy.

Beth Newman

Beth Newman

Aside from the silent auction offering opportunities for paradise getaways and Seahawks tickets behind the 50-yard line, this year’s fundraiser featured a video highlighting the three patients mentioned above and their very different but powerful stories.

However, the PSBC takes pride in more than just raising money as one of four blood centers that conduct research for various programs. As a blood center with a centralized database and testing system, they were instrumental in replacing plastic jars and bottles with glass to store blood more effectively. Its researchers have found new ways to store platelets for cancer patients up to five days, giving the Fred Hutchinson Cancer Research Center an opportunity to continue with bone marrow transplants in a more effective manner. Cheever is proud of the advancements PSBC has made.

“The head of our research institute has found what he believes could be a treatment for pediatric malaria,” said Cheever. “We are lucky enough to be in Seattle where the Gates Foundation and everyone else in town who are looking at vaccines for malaria will certainly help us prevent future generations from getting it.”

Kelly Notter, a PSBC and gala volunteer stated she was very excited about being a part of their efforts.

Many of the gala’s volunteers were excited to have the video be a large part of displaying the work the blood center has aimed to achieve.

Leah Rapalee, Development Coordinator at the PSBC, agreed and said that having the “faces” as a highlight of the night’s event was very important.

“We were just looking at patients trying to show the breadth of the work that we do,” said Rapalee. “They’re also very good speakers and good at engaging with people.”

If you are looking for ways you can help the Puget Sound Blood Center, you can visit their website <> or attend a variety of their other fundraisers including ‘Golf Gets in your Blood 2013’<> in partners with the Bleeding Disorder Foundation of Washington, ‘Swim for Life 2013’<> that funds their Leukemia patient research programs, or the ‘Taste for Life’<> that is put on by PSBC’s Young Professional Ambassadors volunteer group.

KATHERINE LOH is a student in the University of Washington Department of Communication News Laboratory


Lung Cancer

A glimpse into future of cancer screening

Lung Cancer

X-ray showing lung cancer – Photo/NCI

By Elia Ben-Ari
NCI Cancer Bulletin

Ask experts to predict the future of cancer screening, and you’ll get a range of answers.

But all would agree that we need better ways to detect cancers early in the course of disease, and these new tools should improve on the benefits of screening while limiting the harms.

“There have been some improvements in triaging patients with new molecular approaches, but with the possible exception of spiral CT screening for lung cancer, we haven’t had any major breakthroughs in early detection” for more than two decades, noted Dr. David Sidransky, director of head and neck cancer research at the Johns Hopkins University School of Medicine.

The dearth of such advances is not for lack of trying. Developing new screening approaches and rigorously establishing their validity is challenging, however, and there are many potential stumbling blocks along the way.

“The bar for ‘proof’ that a particular screening strategy is clinically effective is very high,” noted Dr. Mark Greene, chief of the Clinical Genetics Branch in NCI’s Division of Cancer Epidemiology and Genetics (DCEG). “A screening test must be shown to reduce the death rate from the disease for which screening is being done.”

Much of the search for new screening tests focuses on biomarkers—proteins, DNA, RNA, or other molecules that can signal the presence of cancer and be detected noninvasively in blood, urine, or other readily obtained patient samples or tissues.

Researchers are also developing new imaging methods that could be used for early detection, either alone or in concert with biomarkers.

Whatever the approach, “screening is moving away from detecting an advanced consequence of cancer, which is the formation of a mass [or tumor], toward detecting the very earliest changes in the cancer process,” said Dr. Larry Norton, deputy physician-in-chief for breast cancer programs at Memorial Sloan-Kettering Cancer Center.

Dr. Norton chairs the external consulting team for the Early Detection Research Network (EDRN), an initiative of NCI’s Division of Cancer Prevention that supports efforts to discover and validate new cancer biomarkers and technologies.

“Molecular detection of cancer is possible only through evidence-based strategies and implementation,” commented Dr. Sudhir Srivastava, who directs the EDRN. “It takes a village to meet the challenges of early-detection research.”

The Post-PSA Era

Microscopic view of prostate cancer

Prostate Cancer

In the case of some cancers, researchers are developing new screening tests because the value of existing tests for those cancers has been called into question, perhaps most notably in the case of prostate specific antigen (PSA) testing for prostate cancer.

“The idea that one biomarker such as PSA is going to be useful for all settings has evolved. We now believe that we’ll need panels of biomarkers,” said Dr. Mark Rubin, a professor of pathology at Weill Cornell Medical College.

To identify those biomarkers, researchers are using methods such as microarrays and whole-genome sequencing, which rapidly yield a wealth of information, to profile changes that occur in cancer.

Using such an approach, Dr. Rubin, Dr. Arul Chinnaiyan of the University of Michigan, and their colleagues discovered the fusion gene TMPRSS2-ERG, which is found in about half of all prostate cancers.

“That fusion gene is seen only in cancer, and, in particular, only in prostate cancer,” said Dr. Rubin, whose team has developed a test to assess the levels of this fusion gene in urine samples. “Our approach now is to try to explain the other 50 percent of prostate cancers with other cancer-specific molecular events” that could eventually form a screening test based on a panel of genetic markers.

For example, Dr. Rubin co-led a recent study that identified a gene called SPOP that is mutated in about 10 percent of prostate cancers.

“We can add that gene mutation to the gene fusion to improve on the test,” he explained. “This is the sort of approach we think will be useful for prostate cancer, as well as other cancers in the future.”

Applying Lessons Learned

To avoid unnecessary biopsies or treatment of prostate and other screen-detected cancers, researchers are trying to find biomarkers that better identify which cancers are likely to progress, noted Dr. Joshua LaBaer, director of the Center for Personalized Diagnostics at the Biodesign Institute at Arizona State University and co-chair of EDRN’s steering committee.

“What we’ve learned from PSA is that if we’re going to come up with new screening tools, we also have to develop tools that give us a better idea of disease prognosis.”

Whereas some cancers detected by screening will progress and metastasize, others may never cause illness during a person’s lifetime.

“What we’ve learned from PSA is that if we’re going to come up with new screening tools, we also have to develop tools that give us a better idea of disease prognosis,” said Dr. James Brooks, a professor of urology at Stanford University.

Dr. Brooks and Dr. Sanjiv Gambhir, chair of the department of radiology at Stanford, lead a project to deploy new technologies that could form the basis for the next generation of prostate cancer screening tests.

To pave the way for tests that rely on panels of blood-based diagnostic or prognostic protein biomarkers, they are starting to test the performance of a magneto-nanosensor chip technology developed at Stanford.

The sensor, which detects proteins tagged with magnetic particles, can measure the levels of up to 64 different proteins simultaneously, in very small sample volumes.

The Stanford team also hopes to adapt an imaging technology being studied in Dr. Gambhir’s lab to improve the accuracy of prostate cancer detection by transrectal ultrasound.

The method uses gas “microbubbles” that are encased in a lipid shell to which specific antibodies are attached as a contrast material for ultrasound imaging.

The antibodies target a receptor for vascular endothelial growth factor, which is a protein found in newly formed tumor blood vessels. The patented antibody-labeled microbubbles are awaiting Food and Drug Administration approval for human testing.

The Stanford team’s long-term goal is to combine their blood-based biomarker and imaging methods to improve early detection and prognostic assessment of prostate cancer and eventually other cancers.

Combining molecular biomarkers and imaging for cancer screening “is a very powerful approach,” commented Dr. Sidransky. “We used to believe in the power of a marker to do everything,” he added. “We now know that’s not true.”

A Sense of Urgency

Researchers have long sought an effective screening strategy for ovarian cancer, and numerous candidate biomarkers for the disease have fallen short of expectations.

“Ovarian cancer is the paradigm for why we need early detection,” said Dr. Michael Birrer, a professor of medicine at Harvard Medical School. The disease can be cured by surgery if discovered early. But “75 percent of tumors are detected at the advanced stage, and those patients are hard to cure,” said Dr. Birrer.

Dr. Birrer and Dr. Steven Skates, an associate professor of medicine at Harvard, are leading a two-pronged effort to discover new biomarker candidates that may ultimately lead to a blood test for the early detection of ovarian cancer.

We used to believe in the power of a marker to do everything. We now know that’s not true.—Dr. David Sidransky

The first strategy will use extensive proteomic profiling of fluids from benign and malignant tissues, such as ovarian cysts, “to find candidate biomarkers that are systematically different between the two,” Dr. Skates explained.

The second strategy involves genomic analyses to identify genes that are expressed differently in ovarian cancer tissue samples than they are in normal tissues that may give rise to ovarian cancer, and then bioinformatic analyses to look for genes whose protein products are also likely to be secreted into the bloodstream.

Using either the proteomic or genomic approach, or a combination of both, the researchers hope to come up with a short list of candidate biomarkers for further testing and refinement.

“We may be lucky to find that some of those candidates are actually early-detection biomarkers that can be measured in blood,” Dr. Skates said.

Those biomarkers could form the basis of a blood test to screen postmenopausal women, and other women at increased risk of ovarian cancer, at regular intervals.

For women who test positive on the blood test, a follow-up test, such as transvaginal ultrasound or newer imaging methods, might be used as part of an overall screening approach in the future, Drs. Birrer and Skates suggested.

Gazing into the Crystal Ball

3d Chromosome with DNA visible insideNo one can predict with certainty which types of tests will be most effective for screening for particular cancers. However, “if you want to prognosticate the future of cancer screening, my guess is that nucleotide [RNA or DNA]-based tests are going to be the most promising, at least in the short term,” Dr. Brooks said. “The power of nucleic acids is that you can amplify them to an extraordinary degree, which you can’t do with proteins,” Dr. LaBaer added.

Future DNA-based screening tests might detect methylation or other epigenetic modifications of DNA that occur specifically in cancer. “For example, we published a paper last year showing widespread and reproducible changes in DNA methylation in prostate cancer,” Dr. Brooks said.

And future screening tests may detect biomarkers in patient samples other than blood or urine. “One area where I think you’re going to see a change is in…tumors that affect the gastrointestinal tract” or other parts of the digestive system, Dr. LaBaer predicted. “You can look in stool for aberrant nucleic acids [from cells shed by tumors].” Researchers are also investigating sputum-based tests to detect lung cancer early.

“A possibility for the future is that we may stop thinking about cancers in terms of organ sites and may think more in terms of disrupted pathways or molecular variants of cancer,” Dr. LaBaer continued. In that case, “the biomarker people are going to have to work closely with the imaging people to very quickly turn a biomarker discovery into identifying where the tumor is.”

“We’re rapidly changing our concept of what cancer is,” noted Dr. Norton. “You can’t separate screening from understanding biology, from therapy, from prevention. The biggest challenge is weaving it all together [into] the big picture.”

Furthermore, he added, “we may find out that early detection is not helpful in certain situations, and that’s also important. We may not want to screen for certain cancers if we find out that prevention may be a better place to put our resources.”

“Mortality rates for some cancers have remained constant for the past 40 years, and in some of these cancers, new therapies have extended life for a few years but are not increasing the cure rates,” Dr. Skates noted. “Improved early detection for these cancers could shift that number so that more people are cured…. The payoff could be so big.”

The NCI Cancer Bulletin is an award-winning biweekly online newsletter designed to provide useful, timely information about cancer research to the cancer community. The newsletter is published approximately 24 times per year by the National Cancer Institute (NCI), with day-to-day operational oversight conducted by federal and contract staff in the NCI Office of Communications and Education. The material is entirely in the public domain and can be repurposed or reproduced without permission. Citation of the source is appreciated.

Red Cross Large

$10 Million Red Cross fine highlights the troubled history of its blood services


by Lena Groeger

A few weeks ago, the Food and Drug Administration hit the American Red Cross with a nearly $10 million fine for safety violations, lax oversight and faulty testing of its blood services.

The fine is just the latest of more than a dozen the Red Cross has racked up in the last decade.

In 2003, a federal court, frustrated by repeated blood safety violations by the Red Cross, gave the FDA the power to fine the organization.

Forty-six million dollars in penalties later, many of the same violations — understaffing, ineffective screening of donors, failure to recall infected blood — are outlined in the recent letter the FDA sent to the executive vice president of Biomedical Services for the Red Cross.

The 32-page letter describes hundreds of violations over several months in 2010 at 16 Red Cross facilities across the country, and details how the Red Cross repeatedly failed to properly track and record information about donors and blood units.

(To see a history of Red Cross fines and many of the documents cited in this article go to ProPublica’s timeline of Red Cross fines.)

For example, the agency failed to notify health departments when donors had infectious diseases such as HIV and syphilis, failed to add new donors with infected blood to a national list of people who aren’t allowed to donate, and failed to review records of donors who had bad reactions, such as a 16-year-old who lost consciousness and fell to the floor after giving a unit of blood.

It also failed to follow written procedures, such as the case of a phlebotomist in Arizona who stuck herself with a needle before sticking a donor with the same needle to draw blood. The case went unreported for a month, because a staff member “was not aware of the need to immediately notify a Medical Director,” according to the inspection letter.

In a recent statement, the Red Cross said it was disappointed that the FDA issued the fine for “an inspection conducted so long ago” and noted that it has “already taken corrective steps to address those matters and that improvements in operations have been made.”

In an email to ProPublica, a Red Cross spokeswoman also said there is no evidence that these violations endangered any patients, adding that the blood supply is safer than it has ever been.

The spokeswoman said the agency has made significant improvements, including reducing the number of problems system-wide by at least 65 percent, and is investing in technology upgrades.

For example, the agency recently upgraded software and computer equipment at blood drives to better collect and track donor information.

The FDA’s letter laying out the fines says the Red Cross “has known of these continuing problems and has failed to take adequate steps to correct them.”

The FDA also noted that “many of the violations recounted in this letter are virtually identical to violations charged in previous [letters].” In June 2010 the FDA imposed a $16 million penalty on the Red Cross for the same type of violations.

The chronic problems raise the question of whether penalties are working at all.

The Red Cross has been making promises and failing to keep them for over a decade, according to Sidney Wolfe, who heads the health research group at the consumer watchdog organization Public Citizen.

Wolfe said he wrote to head of the FDA in 2000, urging it to hold the Red Cross in contempt of court. A federal court first put the Red Cross under government supervision in 1993 after finding blood safety lapses. A decade later, in 2003, the court empowered the FDA to impose fines.

“But fast-forward nine years ahead, and we have the same violations,” Wolfe said.

If the Red Cross disagrees with an assessment, it can ask the FDA to reevaluate the penalty, but in most cases the fine only changes by a few thousand dollars.

Most of the recent problems inspectors cited have to do with managing records and tracking blood donors. The Red Cross says it is unaware of any infections or deaths that stemmed from problems noted in the report, and that “serious problems” account for only three percent of the total problems found.

The FDA doesn’t think that’s good enough.

“FDA cannot definitively say there was never any danger to the blood supply since the violations can create conditions that could lead to potential safety consequences,” said FDA spokeswoman Patricia El-Hinnawy.

The government requires that the Red Cross (like any blood services operation) have multiple safeguards for its blood services.

That includes asking a donor questions to identify any risks, checking his or her name against a national list of people who aren’t allowed to give blood, testing for infectious diseases, keeping track of blood units so infected blood isn’t released, and investigating any deviations from standards.

Because blood transfusions always carry a degree of risk, the FDA considers every step in that process critical to minimizing problems.

“Failure of an individual safeguard does not automatically translate into the release of unsafe products,” an FDA spokeswoman told ProPublica in an email, “however, it may increase the potential for risk.”

In 2008, the Red Cross consolidated its blood work to two facilities: one in Charlotte, N.C., and the other in Philadelphia. The offices are in charge of managing, tracking and, if need be, recalling blood.

But according to the inspection letter, both offices have been chronically understaffed, and simply haven’t been able to carry out their required functions in a timely or effective manner. As of 2010, the offices had a backlog of about 18,000 donor management cases.

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Teens and young adults talk about coping with cancer in new video series


Seattle Children’s has released a new series of videos on the medical center’s YouTube channel featuring a group of teens and young adults talking about coping with cancer.

Each year, about 70,000 young people in the U.S. aged 15 to 39 years are diagnosed with cancer.

In the series, a group of teens and young adults from Children’s Adolescent Young Adult Oncology Program talk about their experiences with the disease – from treatments and hair loss, to dealing with school, friends and family.

The diagnosis of cancer often complicates the lives of young people, who are already grappling with the social and psychological challenges confronting them as they transition from adolescence to adulthood.

Producers of the series hope that seeing other teens and young adults with cancer talk about their experiences will help other young patients struggling with the diagnosis of cancer cope.

“It is so important for these teens and young adults with cancer to know that there is a peer out there that understands what they are going through and that support is available,”  Dr. Rebecca Johnson, medical director of the Adolescent and Young Adult Oncology Program at Seattle Children’s Hospital.

The discussion group was facilitated by Teen Talking Circles, a nonprofit organization that offers teens “a safe place to tell their truth,” and trains adults to start Teen Talking Circles in their communities.

To learn more about the challenges facing teens and young adults with cancer read our series from the NCI Cancer Bulletin.

Series Episodes:

Breast Thumb

Are breast implants safe? — an FDA update


Silicone Gel-Filled Breast Implants: Updated Safety Information

When the Food and Drug Administration allowed silicone gel-filled breast implants back on the market in November 2006, the agency required the manufacturers to conduct follow-up studies to learn more about the long-term performance and safety of the devices.

Today, FDA released a report that includes preliminary safety data from these studies, as well as other safety information from recent scientific publications and adverse events reported to FDA.

FDA approved silicone gel-filled breast implants for increasing breast size (augmentation) in women age 22 or older and for reconstruction (after breast cancer surgery or other medical issues) in all women. They are also approved for revision surgeries, which correct or improve the result of an original augmentation or reconstruction surgery.

Almost five years later, FDA’s report continues to support the safety and effectiveness of these implants when used as intended, but states that women should fully understand the risks before considering getting them.

  • Breast implants are not lifetime devices. The longer a woman has them, the more likely she is to have complications and need to have the implants removed or replaced. Women with breast implants will need to monitor their breasts for the rest of their lives.
  • The most frequently observed complications and adverse outcomes are tightening of the area around the implant (capsular contracture), additional surgeries, and implant removal. Other complications include a tear or hole in the outer shell (implant rupture), wrinkling, uneven appearance (asymmetry), scarring, pain, and infection.
  • Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis. However, no study has been large enough or long enough to completely rule out these and other rare complications.

FDA is working with the two manufacturers who make silicone gel-filled breast implants, Allergan and Mentor, to address the challenges in collecting follow-up data on the women who have received these implants.

“It is important that women with breast implants who experience any symptoms see their health care providers,” says Jeffrey Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Women who have enrolled in clinical studies should continue to participate so that we can better understand the long-term performance of these implants and identify any potential problems.”

FDA also provided other information today on both silicone gel-filled and saline-filled breast implants:

FDA recommends that women with silicone gel-filled breast implants do the following:

  • Follow up. Continue to routinely follow up with your health care provider. Get routine MRIs to detect a rupture that you may not be aware of (silent rupture).  FDA recommends that women with silicone gel-filled breast implants get screenings for silent ruptures three years after they get implants and every two years after that.
  • Be aware. Breast implants are not lifetime devices. The longer you have breast implants, the more likely you are to have complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal within 10 years of implantation.
  • Pay attention to changes. Notify your health care provider if you develop any unusual signs or symptoms. Report any serious side effects to the breast implant manufacturer and MedWatch, FDA’s safety information and adverse event reporting program. Report online at or by calling 800-332-1088.
  • Stay in touch. If you’re enrolled in a manufacturer-sponsored study, continue to participate. These studies are the best way to collect information about the long-term rates of complications.

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

June 22, 2011

E. coli -- Photo: Janice Haney Carr/CDC

Three cases of E. coli infection in the U.S. linked to European outbreak


E. coli -- Photo: Janice Haney Carr/CDC

The U.S. Centers for Disease Control and Prevention (CDC) is investigating three suspected cases of E. coli infections linked to the outbreak in Europe.

All had recently travelled to Hamburg, Germany, the agency reports.

The E. coli strain — Escherichia coli O104:H4 (STEC O104:H4) –produces a toxin that can cause severe, bloody diarrhea and kidney failure, a condition called hemolytic uremic syndrome, or HUS.

The outbreak was centered in Germany, which as for May 31, has seen 470 patients with HUS with nine deaths, the CDC said.

“Any person with recent travel to Germany with signs or symptoms of STEC infection or HUS, should seek medical care and let the medical provider know about the outbreak of STEC infections in Germany and the importance of being tested,” the CDC warns.

To learn more read the CDC update below:

CDC Statement on Outbreak of STEC O104:H4 infections in Germany

CDC is following a large outbreak of Shiga toxin-producing E. coli O104, or STEC O104, infections currently going on in Germany.

As of May 31, 2011, the Robert Koch Institute (RKI), Germany’s disease control and prevention agency, has confirmed six deaths and 373 patients with hemolytic uremic syndrome, or (HUS) (kidney failure), a life-threatening complication of E. coli infections.

To date, no confirmed cases of STEC O104 infections have been reported in U.S. travelers to Europe. Two cases of HUS in the United States have been reported in persons with recent travel to Hamburg, Germany.

CDC is working with state health departments to learn more about these two cases and to identify others. CDC has been in contact with the German public health authorities at RKI. We have alerted state health departments in the United States of the ongoing outbreak.

We have also requested that they report to CDC any cases in which people have either HUS or Shiga toxin-positive diarrheal illness, with illness onset during or after travel to Germany since April 1, 2011.

The strain of STEC causing illness, STEC O104:H4, is very rare. CDC is not aware of any cases of STEC O104:H4 infection ever being reported in United States.

Any person with recent travel to Germany with signs or symptoms of STEC infection or HUS, should seek medical care and let the medical provider know about the outbreak of STEC infections in Germany and the importance of being tested.

Symptoms of STEC infection include severe stomach cramps, diarrhea, which is often bloody, and vomiting. If there is fever, it usually is not very high.

Most people get better within 5–7 days, but some patients go on to develop HUS—usually about a week after the diarrhea starts. Symptoms of HUS include decreased frequency of urination, feeling very tired, and losing pink color to skin and membranes due to anemia.

CDC is not aware that a specific food has been confirmed as the source of the infections. Travelers to Germany should be aware that the German public health authorities have recommended against eating raw lettuce, tomatoes or cucumbers, particularly in the northern states of Germany (Hamburg, Bremen, Lower Saxony, Schleswig Holstein).

We have no information that any of these suspected foods have been shipped from Europe to the United States at this time. The US Department of Defense has been notified of this outbreak because of the presence of U.S. military bases in Germany. We are not aware of any cases among U.S. military personnel.

Here are answers to frequently asked questions:

Would this be the largest E. coli outbreak ever in the world?

We are still learning more about the overall size of this outbreak. The number of HUS cases involved indicates that the outbreak is very large.

Tell us about this rare strain and are we testing for it here?

A very rare strain of Shiga toxin-producing E. coli, or STEC has been reported from some patients in the outbreak. This strain, E. coli O104:H4 has never been seen in the United States, and CDC is only aware of few reports of this strain from other countries.

Although it is rare, the United States’ public health surveillance systems are designed to be able to identify this, and other rare STEC strains, in ill people. However, the ability to detect STEC infections through surveillance depends on proper diagnostic testing of patients presenting with symptoms suggestive of STEC.

In 2009, CDC published recommendations for the diagnosis of STEC infections by clinical laboratories. The illness that it causes is similar to that caused by E. coli O157:H7 which is also a Shiga toxin-producing E. coli and the one most commonly identified in the United States.

Could people travel from Germany and spread it here?

STEC infections can be spread from person to person. The best defense is careful, thorough hand washing. Persons returning from Germany who have diarrhea should be sure to wash hands well with soap and warm water after using the bathroom, and should not prepare food for others while they are ill.

People who are in contact with ill people who recently visited Germany should also follow basic hygiene practices carefully, including washing their hands thoroughly before eating or drinking and after caring for an ill person.

Why so many sick people?

It is too early to know why this is such a large outbreak. The large size may have to do with contamination of a popular food item. However, to our knowledge a specific food vehicle has yet to be confirmed. It is also possible that the unusual strain is particularly likely to cause HUS.


The Modern Legacy of Ancient Viruses


May Eastside Science Café: The Modern Legacy of Ancient Viruses

May 9, 2011 – 7 p.m. – Wilde Rover

In the past century, we’ve seen outbreaks of new viruses such as HIV, SARS and several flu strains, but what about the viruses that came before them? These ancient, extinct viruses (“paleoviruses”) affect modern humans, too. Join Dr. Harmit Malik from the Fred Hutchinson Cancer Research Center to learn how these prehistoric germs have not only shaped our immune system, but also contributed to the repertoire of human genes.

Wilde Rover is located in downtown Kirkland at 111 Central Way.

Multiple Myeloma

Multiple myeloma update


Rep. Ferraro

Multiple myeloma was in the headlines last month, when it took the life of former U.S. Congresswoman Geraldine Ferraro, the first woman in U.S. history to run for vice president on a major party ticket.

In many ways, Ferraro’s battle with the disease was similar to that of many multiple myeloma patients.

Ferraro, for example, felt fine when the disease was first detected in 1998 by routine lab tests that were part of an annual checkup, and this is not uncommon: often patients are symptom-free early in the course of the disease.

In an interview she gave for the Dana-Farber Cancer Institute’s “First Person” series in 2003, Ferraro recalled that after she was diagnosed her physician told her that while there was no cure, there were effective treatments that could help keep the cancer in check for years.

And, indeed, with treatment Ferraro lived nearly 13 more years after her diagnosis.

Today, the outlook for some one newly diagnosed with multiple myeloma has improved somewhat: there is still no cure, but even more effective treatments are available and promising new treatments are in development.

For an update LocalHealthGuide interviewed Dr. William Bensinger, director of the Autologous Stem Cell Transplant Program at the Fred Hutchinson Cancer Research Center, an expert in treating leukemia, lymphoma, multiple myeloma and other blood disorders.

“This is a disease that’s becoming easier to treat,” said Dr. Bensinger. “Patients are living longer—several years longer—and the prospects for new drugs and treatments are improving.”

Multiple myeloma calls. Photo: Matthew Brentnall

Multiple myeloma develops when cells found in the bone marrow, called plasma cells, begin to grow uncontrollably.

The bone marrow, Dr. Bensinger explains, is essentially an organ that makes three major types of blood cells: the oxygen-carrying red blood cells, infection-fighting immune cells and platelets, which are crucial for blood clotting.

Plasma cells are a specialized kind of white cell that make antibodies, proteins found in the blood that attack invading microbes.

Plasma cells are also important in orchestrating bone repair and remodeling, recruiting the cells that breakdown and rebuild damaged bone.

What causes plasmas cells to become cancerous is not known, says Dr. Bensinger, but it is almost certainly some form of genetic damage, but the type of damage may vary from patient to patient.

With some cancers scientists know exactly what has gone wrong, says Dr. Bensinger, “but with multiple myeloma it appears that no single common thing has gone wrong. Instead, different things happen in different patients—that is one reason treating multiple myeloma can be so difficult.”

Once they begin to grow, the cancerous plasma cells crowd out the normal cells of the marrow, hampering the production of red and white blood cells—causing anemia and reducing the body’s ability to resist infections.

The myeloma cells sto;; continue to produce blood proteins, but these are defective, says Dr. Bensinger. “The paradox is that these patients have high levels of antibodies but these antibodies are abnormal and, in fact, suppress the production of normal antibodies–patients end up more susceptible to infection rather than less.”

In addition, these abnormal proteins can also accumulate in and damage other organs, particularly the kidneys, he says.

Bone complications

Meanwhile, at sites where a bone needs repair, multiple myeloma cells stimulate the cells that dissolve damaged bone but fail to recruit a second set of cells that lay down new bone. As a result, the bone is weakened, leading to fractures.

If the rate of bone destruction is high, large amounts of calcium is released into the blood leading to other complications that can include confusion and coma.

Dr. Bensinger

About 20 percent of patients will, like Congresswoman Ferraro, have no symptoms when they are diagnosed, but the typical patients comes to the doctor complaining of pain, often back pain due to vertebral fractures, and fatigue, due to anemia, says Dr. Bensinger.

Those who have no symptoms are usually followed until symptoms or complications develop, because treatment at this stage has not been shown to help prolong life, Dr. Bensinger says.

For those with symptoms or complications, there are a number of treatment options. At the Fred Hutchinson Cancer Research Center, patients 70 years old and younger who don’t have other serious medical problems, the recommended treatment is a procedure called autologous stem cell transplant.

In this procedure, blood stem cells that are capable of reconstituting the bone marrow are collected from the patient’s blood and frozen for storage. These cells will be used to repopulate the bone marrow after the chemotherapy.

Once the blood stem cells are harvested, the patient is then treated with a combination of chemotherapy drugs with the aim of killing all or at least most of the cancerous multiple myeloma cells.

This treatment kills the normal cells as well, but in most cases the marrow can be restored by infusing the harvested stem cells, which can quickly repopulate the marrow.

About half of patients undergoing this procedure will have what is called a “complete remission”, meaning no sign of the multiple myeloma can be detected. “Remission is not a cure,” says Dr. Bensinger, “but those who have complete remission live longer.”

Overall, patients who undergo this procedure have a median survival rate of 7 years, meaning that half live less than 7 years and half live longer.

This compares to a median survival rate of about 5 years for all patients. In some cases, a second autologous stem cell transplant—a so-called tandem transplant—can achieve remission in a patient who failed to achieve complete remission with the first treatment.

Another option is a procedure called an allogenic stem cell transplant. In this procedure, instead of the patient’s own cells, blood stem cells from a donor are used to repopulate the patient’s bone marrow after chemotherapy.

But this treatment is risker: because these cells come from a genetically different person, their immune cells will see the patient’s cells and tissues as “foreign” and, as a result, attack them.

This reaction, called graft vs. host disease, can be deadly if severe. But if the reaction is less severe, the grafted cells can actually help by attacking any myeloma cells that have survived the chemotherapy treatments, phenomenon called graft vs. Tumor effect.

“The new stem cells have the capacity to destroy the small amounts of the multiple myeloma cells left behind,” says Bensinger, “and the net result is that you see higher response rates and more durable remissions.” And there is some evidence, though it is controversial, that patients with multiple myeloma have been cured after allogenic stem cell transplants, he says.

The problem with this approach is that the complication rate is very high with as many as 15 percent to 20 percent dying as result of the procedure compared to 1 percent to 2 percent of autologous stem cell transplant patients.

In addition to the transplant procedures there are a number of drug treatments that have been shown that can help keep multiple myeloma in check. These include combinations of some traditional chemotherapy agents, some newer immunomodulating compounds, and new drugs that target multiple myeloma cells more specifically.

Some of these are newer drugs will be available as part of clinical trials now underway or soon to be launched at the Fred Hutchinson, said Dr. Bensinger, including trials to see whether starting early treatment with newer drugs can be beneficial.

Photomicrograph of the multiple myeloma cells courtesy of the Multiple Myeloma Research Foundation.

To learn more:

  • Visit the Multiple Myeloma Research Foundation’s webpage.
  • Visit the National Library of Medicine’s Medline Plus page on Multiple Myeloma.