All posts by BIeditor

4 in 10 Adults Over 50 Consult Online Reviews When Picking a Doctor

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Steven Reinberg, HealthDay: April 14, 2021

Finding a new doctor can be a daunting task. For help, many older adults turn to online reviews, a new study finds.

In fact, many people rate online reviews as highly as they would a recommendation from friends and family when picking a doctor, the new research found.

“Doctors and policymakers should know that many older adults are viewing and valuing online ratings and reviews when choosing physicians,” said researcher Dr. Jeffrey Kullgren. He’s an associate professor of internal medicine at the University of Michigan in Ann Arbor.

[….]

Diana Zuckerman is president of the National Center for Health Research, a nonprofit think tank that conducts research on a range of health issues. She said that choosing a doctor is a complex undertaking.

“The trouble with these ratings is they’re not based on how good the physician is,” said Zuckerman, who wasn’t involved in the new study. “They’re usually based on convenience issues, like how long do you have to wait in the waiting room, how nice is the doctor, and does the doctor listen to you. These are all nice things, but they’re not really the important things.”

[….]

In all, the survey found that 40% of adults aged 50 to 80 have used online doctor rating sites and trust them almost as much as recommendations from family or friends for choosing a doctor. Also, online ratings were seen as more important than where a doctor went to medical school or trained.

[….]

Women, people with more education and those with chronic conditions were the most likely to turn to online rating sites, the investigators found.

[….]

Zuckerman said that most people don’t have the expertise to rate a doctor in ways that are meaningful in terms of how good a physician is or how good the medical care that they’re going to get is.

Often, online ratings should be taken with a grain of salt, she said, because you don’t know exactly what the ratings are based on.

The recommendation of friends or family members can be helpful, but in the end, it’s going to be how your experience with a doctor measures up to your needs and expectations that are important. And you shouldn’t be afraid to change doctors if you’re dissatisfied with your care, she advised.

Zuckerman agreed with the researchers that it’s up to policymakers and clinicians to set standards and criteria for online reviews. Patients, too, need to understand the pros and cons of online ratings.

You can read the entire article here.

What Genentech is doing to fix biotech’s diversity problem

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Fortune Editors, Fortune: April 7, 2021

There’s a big problem with clinical trials: a lack of diversity. And that issue is ultimately detrimental to countless people’s lives and health.

Take, for example, breast cancer research. For a long time, the thinking in the health care world was that Black women didn’t develop breast cancer as often as white women, but when they did, they were more likely to die because of it.

“There was this assumption that it was an issue of access to care, the quality of care,” says Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank that analyzes the latest research and helps consumers and organizations put that information to work. But “if you looked at the research, you saw that the original major studies of breast cancer treatment were done on white women.”

That meant the research featured fewer women with triple-negative breast cancer, which Black women develop more often than white women. “Because [women with triple-negative breast cancer] weren’t studied,” Zuckerman continues, “[the researchers] didn’t realize that the treatments that they were studying would not work on those types of cancer.”

Zuckerman talks with Fortune’s Ellen McGirt on this week’s episode of Leadership Next, a podcast about the changing rules of business leadership. Also on the episode with McGirt and cohost Alan Murray is Alexander Hardy, who became CEO of biotech company Genentech two years ago.

Hardy has made it clear that he’s committed to boosting diversity within the biotech world and in clinical trials, and he was already doing so before the pandemic. But COVID-19 crystallized some of the issues in the U.S.

[….]

During the show, Hardy also discusses the ways the COVID-19 pandemic has changed the biotech industry, and how those changes could spill over into research on diseases such as Alzheimer’s, ALS, and cancer.

To read the entire article and listen to the podcast, click here.

Coronavirus Relief Act Gives Drug Makers New Sway Over FDA

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By David S. Hilzenrath, Project on Government Oversight:

Last year, based on growing concerns about the safety of certain sunscreens, the Food and Drug Administration (FDA) published a plan of action.

It proposed concluding that, for two sunscreen ingredients, the risks outweigh the benefits, and it proposed declaring that there was insufficient data to support the safety of a dozen others—for example, one that has shown up in blood plasma, amniotic fluid, urine, and breast milk.

It proposed restricting properties of spray sunscreens to reduce the risk of inhaling them and suffering lung disease, and it proposed requiring that many sunscreens meet a stricter standard for protection against ultraviolet radiation.

It said it wanted to eliminate “potential confusion permitted by the current labeling regime,” under which a product labeled with a higher sun protection factor or SPF can provide “inferior protection” than one with a lower SPF because it filters a narrower spectrum of ultraviolet radiation.

The FDA’s proposal was apparently derailed by the coronavirus.

More specifically, by part of Congress’s response to the pandemic: the economic relief legislation known as the CARES Act, passed in late March.

While Americans were focused on a deadly plague and its devastating fallout, Congress fundamentally altered FDA oversight of thousands of drugstore items.

Little-noticed provisions of the CARES Act gave manufacturers new sway over the consumer protection agency and streamlined the process by which the FDA makes decisions about so-called over-the-counter or OTC drugs—products marketed for personal health and sold without a prescription.

[…]

“User Fees”

[…]

While the CARES Act requires the FDA to negotiate with industry, it requires the agency to “consult” with others, such as “representatives of patient and consumer advocacy groups.” In the realm of prescription drugs, the so-called patient advocacy groups the FDA consulted the last time user fees came up for renewal generally had ties to the pharmaceutical industry, POGO’s 2016 “Drug Money” investigation found.

The FDA and manufacturers have for years been laying the groundwork for adoption of user fees for over-the-counter products. In 2016 and 2017, they held a series of meetings on the subject. Industry participants included Procter & Gamble, Bayer, Sanofi, Johnson & Johnson, and a trade association, the Consumer Healthcare Products Association.

The plan the FDA and industry developed set out “performance goals” for the agency to meet under an anticipated user fee regime, including what the document describes as “substantially shortened timeframes” for the FDA to act on requests from manufacturers of over-the-counter drugs.

“This goals document represents the product of FDA’s discussions with the regulated Industry, and consideration of input by public stakeholders,” the document, called a “commitment letter,” says.

The performance goals “are important for facilitating timely access to safe and effective medicines,” the document says.

The plan the FDA and industry developed was contingent on action by Congress. Now that Congress has acted, the FDA plans to follow the performance goals in that document, FDA spokesman Charlie Kohler said in an email to POGO.

Diana Zuckerman, president of the National Center for Health Research, said the commitment letter “does not seem appropriate.”

“Performance goals should include at least as much attention regarding evidence of safety or effectiveness as it does to the issues that industry cares the most about,” Zuckerman said by email.

Historically, industries have embraced user fees as a means of reducing regulatory delays. For Congress, getting companies to pay for regulators’ salaries has been an easier pill to swallow than spending taxpayer dollars or adding to federal budget deficits.

The new user fees will enable the FDA to increase its budget and staffing for overseeing nonprescription drugs.

In the 2016 slide presentation, the FDA said it was spending just $8.2 million a year and had the equivalent of only about 30 full-time employees to oversee “hundreds of thousands of products consumed – in many cases, on a daily basis – by millions of Americans.”

The FDA compared the $8.2 million to what it said was the $8 million cost of producing “the ‘Blackwater’ episode of the hit TV series Game of Thrones.”

According to the industry’s Consumer Healthcare Products Association, over a five-year period, the user fee program will generate more than $130 million in fee revenue for the FDA.

 

[…]

Read the full article here. 

What People With Cancer or Compromised Immune Systems Need to Know about Coronavirus (COVID-19)

Uncategorized, ,

National Center for Health Research: Updated November 15th, 2022

The coronavirus can infect anyone, young or old, healthy or frail. People with cancer and other serious health conditions, and their loved ones, need to be especially careful. Here’s what you need to know.

Some cancer treatments, such as chemotherapy, targeted therapies, immunotherapy, and radiation, can weaken the immune system and possibly cause lung problems. People who have weakened immune systems or lung problems are more likely to have serious symptoms if they become infected with this virus. Anyone with cancer in the lungs (whether lung cancer or cancer that has spread to the lungs) is especially at risk if they develop COVID-19.

What is coronavirus?

Coronaviruses are a large group of viruses that can cause respiratory illness. The new (novel) coronavirus is called SARS-CoV-2 and the illness it causes is called coronavirus disease 2019, which is why it’s abbreviated as COVID-19.  Since it is new, nobody has immunity from it.

How does COVID-19 spread between people?

The virus usually spreads through close contact with other people, especially through droplets when a person coughs or sneezes – or even when they breathe normally. These droplets can travel through the air and can be inhaled or get into the noses, mouths, or eyes of people nearby.

It is most contagious when the person has symptoms, but it is possible to catch the virus from infected people who have no symptoms at all. In addition, these droplets (as well as fecal matter containing the virus) can end up on surfaces where it can survive for short periods of time.

Symptoms tend to start between 2 and 14 days after coming into contact with the virus. Although some people have compared the symptoms to a cold or flu, not everyone with COVID-19 has those types of symptoms. In fact, some people (especially children, teens, and younger adults) have very mild symptoms or none at all, which is why getting tested is so important before you spend time with others. These symptoms have been reported in people with COVID-19:

·       Fever or chills

·       Cough

·       Shortness of breath or difficulty breathing

·       Fatigue

·       Muscle pains

·       Headache

·       New loss of taste or smell

·       Sudden confusion (delirium)

·       Skin rash, redness on toes/fingers

 ·       Chest pains

·       Sore throat

·       Congestion or runny nose

·       Nausea or vomiting

·       Diarrhea

·       Skipping meals

·       Abdominal pains

·       Sneezing

·       Changes in the mouth or tongue

Studies out of the United Kingdom show that the most common symptom associated with COVID-19 is a sore throat, with fever and loss of smell becoming rarer in patients. Tim Spector, a professor of genetic epidemiology at King’s College London, reported that “COVID starts in two-thirds of people with a sore throat,” which is something to keep an eye out for if you think you may have COVID.

Most people who are infected with this coronavirus have mild symptoms and can recover at home in about 2 weeks. However, symptoms can become severe. These are the ones that require immediate medical attention:

  • Difficulty breathing or shortness of breath
  • Persistent chest pain or pressure
  • Confusion or inability to awaken
  • Blueish color in the lips or face

People who are older than 60 or with other medical conditions are more likely to develop severe illness and complications from COVID-19. The most serious complications include pneumonia, stroke, blood clots, organ failure, and death.

How can I protect myself and others?

If you live in the U.S., the best way to protect yourself and others it to get one of the 3 vaccines available. The vaccines are widely available throughout the U.S. in multiple locations from community health centers to local pharmacies. Treatment options for COVID-19 do not cure the virus but FDA has designated treatments can help prevent hospitalization and death. The FDA has approved one drug treatment for COVID-19 and granted emergency use authorizations (EUAs) for 12 drug treatments, two of which were later rescinded. However, several of the remaining 10 treatments are now rarely used. Details about available treatments are described here.

What if you are pregnant?  Research shows that COVID infection is dangerous to pregnant women and that vaccinating pregnant women is safe.  For example, a study of more than 24,000 newborns, of whom almost 17,000 were exposed to a mRNA COVID vaccine in the first or second trimesters when their mothers were vaccinated, found no differences in preterm birth rates, neonatal hospitalizations, congenital abnormalities or infant mortality.  A small study found that most infants born to COVID-vaccinated mothers had persistent antibodies at 6 months, compared with infants born to mothers who had been infected with SARS-CoV-2.

In contrast to vaccination, a COVID infection increases the chances of serious harm for pregnant women.  A retrospective study of more than 14,000 pregnant women found that those with COVID infections were more likely to die or have serious illness related to hypertensive disorders of pregnancy, postpartum hemorrhage, or infection other than SARS-CoV-2 compared to pregnant women who did not have a COVID infection (13% vs 9%).  All 5 maternal deaths in the study were women who were infected with COVID.

What should I do if I develop symptoms?

If you develop more than one of the symptoms listed above, get tested for COVID, using an at-home test. That’s the fastest way to get results, but keep in mind that the rapid tests (whether at home or anywhere else) are not as accurate as the PCR test. If you have symptoms but your rapid test is negative, test yourself again a day or 2 later, because the tests get more accurate after a few days of symptoms.

If you have symptoms that worry you, call your doctor whether or not you test positive. If you have severe symptoms, such as difficulty breathing, persistent chest pain or pressure, confusion or inability to awaken, or blueish color in the lips or face, you need to call 911. Tell the 911 operator that you think you have COVID-19 so the responders can take the necessary precautions to protect themselves.

People who experience mild symptoms can usually stay home and will recover in about 2 weeks. People are discouraged from simply showing up at the doctor’s office with symptoms: Call them first so you have tell them about your symptoms and any other health problems so that they can help decide what to do. If you do become sick, you can take the following steps to protect others:

  • Get tested for COVID-19, ideally with a PCR test to confirm the results (positive or negative) of your at-home test
  • Wear a face mask
  • Stay home, unless you need essential medical care
  • Stay away from others in your home as much as possible
  • Cover your mouth and nose when you cough or sneeze, properly dispose of tissues, and wash your hands
  • Monitor your symptoms and temperature

If you were not tested for COVID-19, you should follow those steps until at least one or two weeks have passed since you first noticed symptoms or your fever or other symptoms go away for 3 full days without medicine. If you have been diagnosed with COVID-19 based on test results, you should follow those same steps until you have 2 negative test results taken 24-hours apart, and your symptoms improve.

What if my cancer treatment is delayed?

When a person is diagnosed with cancer, they are likely to want treatment as soon as possible.  Treatment or testing may seem more urgent than it really is, especially with cancers that often grow slowly, such as prostate cancer or breast cancer. And, if you don’t have COVID-19, you don’t want to be exposed to it during cancer surgery, testing, or follow-up appointments.  Talk to your doctor about what is the best strategy to get the treatment you need when it is safe to do so.

Questions?

We are here to help by answering your questions.  We do not provide medical care.  If you have questions contact info@center4research.org and we’ll get back to you as soon as possible.

 

FDA considers black box warning for all breast implants

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Mariel Carbone, WCPO Cincinnati: February 09, 2020

Although many other survivors choose implants after their mastectomies, [Lily McBreen is] adamant that she won’t. Having almost lost her life once, she’s worried the side effects of receiving breast implants could endanger it again.

[…]

“I wanted to avoid the rheumatological symptoms that have been out in the news for so many decades,” she said. “There has been so many accounts of women complaining of problems with them.”

Those symptoms, which women are calling “breast implant illness,” are among the many reasons the United States Food and Drug Administration could soon take extreme measures when it comes to educating the public about implants.

[…]

Currently, the black box warning exists only as a draft while the FDA continues to consider its implementation.

The draft warning outlines three main concerns.

First, “breast implants are not considered life time devices” and women may require more surgery if complications occur.

It also states that implants have been associated with BIA-ALCL.

[…]

Finally, it describes how some patients have reported a variety of symptoms, including “joint paint, muscle aches, confusion, chronic fatigue, autoimmune disease and others.”

The FDA is also proposing a patient decision checklist, which would include situations in which the device should not be used, considerations for a successful breast implant candidate, risks of surgery, the importance of using an appropriate physician, the risk of BIA-ALCL and other symptoms and discussion of other options.

Still, some have said these proposals don’t go far enough, including Diana Zuckerman who is President of the National Center for Health Research. The center initiated the Breast Implant Working Group, which is made up of six experts including patient advocates and plastic surgeons.

“The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients,” the working group said in a statement. “The FDA draft Black Box states that ‘breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).’ Association implies correlation rather than causation. In fact, the evidence is clear that breast implants can cause BIA-ALCL.”

Read the original story here.

No Shortage of Controversies for New FDA Commissioner

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Thomas M. Burton, The Wall Street Journal: January 29, 2020

New Food and Drug Administration commissioner Stephen M. Hahn rises at 4 a.m. each day for an hour of intensive strength and stamina training. On stressful days, he fits a second workout in during the late afternoon.

Dr. Hahn, 60, takes over an FDA under fire for failing to adequately respond to the health threat from growing use of e-cigarettes and vaping products. This spring, he and the agency will face applications from e-cigarette companies and have to decide what e-cigarette products can qualify to stay on the market.

[…]

Dr. Hahn also faces thorny decisions on stem-cell research and use of cannabidiol, or CBD, that will likely put him in the hot seat between rival advocacy groups.

The man taking on these challenges comes to the FDA with a sterling reputation in medicine and management, but with no previous government experience, unlike his predecessor Scott Gottlieb. That has some concerned about his ability to tackle the issues ahead.

“Always we have concerns when someone comes in who doesn’t know the FDA, which is a complex organization,” said Diana Zuckerman, president of the public-interest research group National Center for Health Research in Washington.  “I never think it’s a good idea.”

What’s more, Dr. Hahn may not have long to make his mark if Mr. Trump fails to win re-election Nov. 3. “It’s a hard thing to come in with so little time [in the president’s term] and so little government experience,” said a former FDA commissioner, Robert Califf, who served under President Obama. “It’s so difficult to change policy with so little time.”

Dr. Hahn didn’t immediately comment for this article.

[…]

Read the original story here.

Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

Testimonies and Statements by NCHR, , , ,

Scot Glasberg, MD,  Diana Zuckerman, PhD, Alan Matarasso, MD, Karuna Jagger, Raylene Hollrah, Jamee Cook, and Maria Gmitro, December 23, 2019

Download the comment here.

Comment to the FDA Docket on the FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

A Working Group comprised of two former presidents of the American Society of Plastic Surgeons, the president of a national research center, and four nationally respected patient advocates came together to find common ground regarding the risks of breast implants.   As individuals (Dr. Scot Glasberg, Dr. Alan Matarasso, Dr. Diana Zuckerman, Ms. Karuna Jagger, Ms. Raylene Hollrah, Ms. Jamee Cook, and Ms. Maria Gmitro), we are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person is considering surgery.

Black Box Warning

The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients.  For example, it should specify that breast implants can cause ALCL, breast implants are not lifetime devices (instead of FDA’s proposed Black Box wording that they are “not considered lifetime devices), replace technical jargon, and be more explicit about the evidence regarding breast implant illness instead of making it sound like it is not a real risk.

The FDA draft Black Box states that “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”  Association implies correlation rather than causation.  In fact, the evidence is clear that breast implants can cause BIA-ALCL.

The FDA draft says that the rates of BIA-ALCL “are not well defined.”  Although correct, that terminology will not be understood by all patients.  Instead, it should state that the rates “are not known.”

We agree with the FDA draft that it is important to illustrate the seriousness of BIA-ALCL by stating that “Some patients have died from BIA-ALCL.”

The draft Black Box wording regarding symptoms of breast implant illness would be confusing to patients.  It refers to systemic symptoms, which is the correct term, but not one that all patients would understand.  It does not mention breast implant illness, which although not an established medical term, is one that is well understood by patients.  The FDA draft background paper and Black Box warning both state that “some” patients with breast implants “have reported a variety of systemic symptoms,” which implies that the numbers of women with these symptoms is small and that they reported the symptoms but that they haven’t been diagnosed.  That is incorrect.  The wording should be changed to “patients have experienced a variety of symptoms.”  The FDA proposed Black Box statement that “some patients report complete resolution of symptoms” again implies that these improvements are reported but not medically confirmed.

On the contrary, a review of several well-designed studies by De Boer et al. (2017) found that most women with breast implant illness who had their implants removed and not replaced were confirmed by physicians to have complete or substantial improvement in their symptoms and overall health.

In addition, the FDA draft Black Box does not mention the risk of autoimmune/connective tissue diseases.  The Black Box should specify that “several studies suggest that women with silicone gel or saline-filled breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases.” That statement is supported by the largest long-term study to date, by Watad et al. (2018), a retrospective analysis of 24,651 women with breast implants (confirmed by medical records) and 98,604 matched women who did not have breast implants. The strongest association with breast implants (OR>1.5, p<0.001) was recorded for Sjögren’s syndrome, systemic sclerosis (scleroderma) and sarcoidosis, based on new medical diagnoses made after the women received breast implants, which were included in medical records during a period of up to 20 years.  In addition, (Coroneos et al. 2019) reported that Allergan’s study of 60% of the almost 50,000 women they enrolled in their study submitted to the FDA, physicians’ diagnoses of their patients two years after their implant surgery found statistically significant increases in fibromyalgia, rheumatoid arthritis, and lupus compared to the general population.  Although the Mentor data reported in that study are very flawed, the Allergan data, which were provided to the FDA, seem solid.

Patient Informed Consent Checklist

The Breast Implant Working Group created a checklist that was provided to the FDA in October.  This checklist has been endorsed by the American Society of Plastic Surgeons, the National Center for Health Research, Breast Cancer Action, Our Bodies Ourselves, National Women’s Health Network, Jacobs Institute for Women’s Health, Breast Implant Victims Advocacy, Just Call Me Ray, and Breast Implant Safety Alliance.  It was also supported by more than 77,000 individuals who signed a petition that the Working Group provided to FDA officials on December 9, 2019

We agree with the FDA that the purpose of a patient checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. Based on our experience with patients, we urge the FDA to ensure that the checklist is:

  • Brief and easy-to-understand, formatted with information on specific issues that are presented succinctly;
  • Jargon-free. Keep in mind that the average reading level in the U.S. is 6th
  • Organized to focus on the information that patients are less likely to obtain from other sources. It should not start with lengthy sections that are not especially interesting to patients.

Focus and Organization of the Checklist

The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms. It is therefore essential that the checklist provide information that thousands of implant patients have stated they were not warned about.  For that reason, the checklist should not focus on surgical and cosmetic risks, which are the types of risks that all patients are warned about in standard consent forms.  Instead of the almost full page of mostly surgical risks that are listed at the beginning of the FDA’s draft checklist, such risks should be summarized very briefly in one sentence, with the checklist focused on other risks that patients could otherwise not be aware of.  Similarly, cosmetic and local risks should be listed last in the checklist, since that information is more likely to be provided through other means.

The FDA draft checklist starts with “Considerations for a Candidate for Successful Breast Implantation,” cancer risk and a short section on “systemic illness.”  We suggest shorter, more focused headings and information to make the checklist more engaging and easy to read.

Who shouldn’t get breast implants?

The above heading should replace “Considerations for a Candidate for Successful Breast Implantation,’ since that latter heading implies that the patient characteristics listed are the only ones that would reduce the chances of complications or other problems.  In terms of content, the FDA draft wording on who should not get breast implants contains important information but is much too long and includes information that could be summarized.  The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms.  We recommend a short summary regarding active infections, cancer, or wound healing, and the following wording instead:

I understand that the safety of breast implants was never studied for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Risk of Cancer: BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma)

We recommend that the FDA’s draft wording for BIA-ALCL could be improved as follows:

I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.

Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance. 

Systemic Symptoms:  Breast Implant Illness

As noted earlier, “Breast Implant Illness” should be the term used, since “systemic symptoms” is not a term that all patients would understand.  Also as noted earlier, the FDA draft guidance and draft checklist consistently imply that the number of women reporting symptoms of breast implant illness is small and that there is no research evidence that the symptoms are caused by their implants.  For example, the FDA’s draft wording that “some women report” implies that a small number of women are claiming an illness that isn’t real.  It is more accurate and meaningful to patients to say that several studies support the apparent causal link to breast implant illness symptoms (Watad et al 2017 and Colaris et al. 2017) and to symptom improvement after implants are removed (DeBoer et al. 2017), for example).  It should also state that the largest, long-term studies also indicate a statistically significant increase in certain autoimmune or connective tissue diseases, as summarized on page 2 of this document, citing Watad et al. 2018 and Coroneos et al. 2019). For that reason, ASPS, researchers, women’s health organizations, and patient groups endorse the following wording:

I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include symptoms such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and skin problems.

Several studies of women with breast implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women:  Chronic Fatigue Syndrome; Multiple Sclerosis (MS); Rheumatoid Arthritis (RA); Sjögren’s syndrome; and Systemic Sclerosis/Scleroderma.

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Breast-Implant Specific Risks

This heading in the FDA’s draft Checklist is misleading, since BIA-ALCL and many other risks of breast implants are specific to breast implants.  More important, this section is much too long and includes too many topic areas.

We therefore recommend the following shorter, more specific sections:

How long do breast implants last?

It’s essential that patients understand what it means when experts say that breast implants “don’t last a lifetime.”  Since many implant patients are young, some think that means they only last 30-50 years.  Even saying “the longer you have them, the more likely they are to break” can be misinterpreted to refer to 30 or 40 years later.  For that reason, the Working Group Checklist specifies “Implants may rupture or leak at any time, and that is more likely the longer you have them” and that “it is likely that I will need other surgeries related to my breast implants over the course of my life.”

The wording should be succinct, explicit, and easy to understand.  Augmentation patients are already aware that their insurance policy does not cover cosmetic surgery, but it is important for them to also know that insurance is unlikely to cover subsequent surgeries due to complications or breakage, since they might mistakenly assume that problems related to implants will be covered even if the initial cosmetic surgery is not.  We recommend the following wording:

I understand that breast implants are not expected to last for the rest of my life.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries for removal, and probably would not cover replacement. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Chemicals and Metals in Breast Implants

Patients should be informed about the chemicals and metals in the specific make and model of breast implants they are considering.  Since the checklist is for all breast implant patients, it should include a brief, general statement about chemicals and heavy metals, but each patient should get separate, more detailed information about the specific model of implant they are considering.  We recommend the following wording for the checklist:

I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Rupture and Leakage

Patients would benefit from a section with a heading of “Rupture and Leakage.”  Although this overlaps with the issue of how long implants last, more specific information about silent rupture is important.  We recommend the following wording for the checklist, understanding that if FDA no longer recommends MRIs after 3 years, that wording should be revised, but the explicit information about the risks of silicone migration should be included:

I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by mammogram, MRI, or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Capsular Contracture

Capsular Contracture is a common complication that therefore should have its own heading.  Our recommended wording is as follows:

I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Breast Cancer

Breast cancer issues should be a separate heading in the checklist, not part of the section on ACLC, in order to avoid confusion.  Our recommended wording is as follows:

I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.

Interference with Breastfeeding

Since the data are lacking, our recommended wording is as follows:

I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Loss of Sensation to Breast or Nipple(s)

Many women do not understand that breast implant surgery can cause loss of sensation.  While more likely among reconstruction patients, it is important to note that augmentation patients can also experience loss of sensation or painful sensitivity.  We therefore recommend this wording:

I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Cosmetic Complications

Cosmetic complications should be the last section of the checklist, because like surgical complications they are often included in standard informed consent documents.  We recommend the following brief, easy to understand, but explicit warnings, such as using the term “sag” instead of ptosis:

I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.

 

FOOTNOTES:

Colaris MJ, de Boer M, van der Hulst RR, Cohen Tervaert JW. (2017) Two hundred cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature. Immunologic Research 65(1):120-128. doi: 10.1007/s12026-016-8821-y

Coroneos C, Selber J, Offodile A, et al. (2019) US FDA breast implant postapproval studies: Long-term outcomes in 99,993 patients. Annals of Surgery 269(1):30-36. doi: 10.1097/SLA.0000000000002990

De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. doi: 10.1007/s12026-016-8813-y

Watad A, Quaresma M, Brown S, et al (2017) Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome)—an update. Lupus 26(7):675-681. doi:10.1177/0961203316686406

Watad A, Rosenberg V, Tiasano S. et al. (2018) Silicone breast implants and the risk of autoimmune/rheumatic disorders: A real-world analysis. International Journal of Epidemiology. 47(6):1846-1854. doi: 10.1093/ije/dyy217

 

 

Device warning letters plunged nearly 90% over 5 years. An FDA official predicts a rebound

We Are Quoted

FDA warning letters to medical device manufacturers slid by nearly 90% between 2015 and 2019, but may be set to rebound upward in 2020, according to device center Associate Director for Compliance and Quality Erin Keith. Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency.

[…]

Diana Zuckerman, president of the National Center for Health Research, said the trend is emblematic of a regulator that is overly focused on pleasing industry.

“It could have several different causes, reorganization could be one. [Medical Device User Fee Amendments] regulations could be part of it, which requires more meetings. But there is this emphasis on customer service, which is defined as making life easier for the industry. Industry is an important customer, but so is the American taxpayer,” Zuckerman said.

[…]

Another method FDA has utilized is increasing the number of alternative methods of disseminating information, such as issuing Letters to Health Care Providers and Safety Communications. For example, in April 2019, the agency issued a safety communication alerting patients and providers of mammography problems at a medical clinic in Ohio, noting the facility “was unable to meet the parameters for a key quality control test on the day of the 2018 annual inspection.” FDA noted in the safety communication quality problems at East Palestine Family Medical Clinic dated back to October 2017, and recommended patients screened at the facility receive an additional mammography.

[…]

Read the original story here. 

Breast Implant Working Group’s Comments on FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

Testimonies and Statements by NCHR, , ,

Scot Glasberg, MD,  Diana Zuckerman, PhD, Alan Matarasso, MD, Karuna Jagger, Raylene Hollrah, Jamee Cook, and Maria Gmitro, December 23, 2019

Download the comment here.

Comment to the FDA Docket on the FDA’s Draft Guidance to Improve Patient Communication on Breast Implants

A Working Group comprised of two former presidents of the American Society of Plastic Surgeons, the president of a national research center, and four nationally respected patient advocates came together to find common ground regarding the risks of breast implants.   As individuals (Dr. Scot Glasberg, Dr. Alan Matarasso, Dr. Diana Zuckerman, Ms. Karuna Jagger, Ms. Raylene Hollrah, Ms. Jamee Cook, and Ms. Maria Gmitro), we are urging that the FDA require a black box warning and Patient Informed Consent Check List that provides information about the risks of cancer, breast implant illness, and other serious health problems in explicit and easy-to-understand wording that all individuals considering breast implants can understand, regardless of educational level or stress that is inevitable when a person  is considering surgery.

Black Box Warning

The FDA’s draft Black Box warning is too vaguely worded on BIA-ALCL and breast implant illness, and includes jargon that will not be understood by all patients.  For example, it should specify that breast implants can cause ALCL, breast implants are not lifetime devices (instead of FDA’s proposed Black Box wording that they are “not considered lifetime devices), replace technical jargon, and be more explicit about the evidence regarding breast implant illness instead of making it sound like it is not a real risk.

The FDA draft Black Box states that “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).”  Association implies correlation rather than causation.  In fact, the evidence is clear that breast implants can cause BIA-ALCL.

The FDA draft says that the rates of BIA-ALCL “are not well defined.”  Although correct, that terminology will not be understood by all patients.  Instead, it should state that the rates “are not known.”

We agree with the FDA draft that it is important to illustrate the seriousness of BIA-ALCL by stating that “Some patients have died from BIA-ALCL.”

The draft Black Box wording regarding symptoms of breast implant illness would be confusing to patients.  It refers to systemic symptoms, which is the correct term, but not one that all patients would understand.  It does not mention breast implant illness, which although not an established medical term, is one that is well understood by patients.  The FDA draft background paper and Black Box warning both state that “some” patients with breast implants “have reported a variety of systemic symptoms,” which implies that the numbers of women with these symptoms is small and that they reported the symptoms but that they haven’t been diagnosed.  That is incorrect.  The wording should be changed to “patients have experienced a variety of symptoms.”  The FDA proposed Black Box statement that “some patients report complete resolution of symptoms” again implies that these improvements are reported but not medically confirmed.

On the contrary, a review of several well-designed studies by De Boer et al. (2017) found that most women with breast implant illness who had their implants removed and not replaced were confirmed by physicians to have complete or substantial improvement in their symptoms and overall health.

In addition, the FDA draft Black Box does not mention the risk of autoimmune/connective tissue diseases.  The Black Box should specify that “several studies suggest that women with silicone gel or saline-filled breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases.” That statement is supported by the largest long-term study to date, by Watad et al. (2018), a retrospective analysis of 24,651 women with breast implants (confirmed by medical records) and 98,604 matched women who did not have breast implants. The strongest association with breast implants (OR>1.5, p<0.001) was recorded for Sjögren’s syndrome, systemic sclerosis (scleroderma) and sarcoidosis, based on new medical diagnoses made after the women received breast implants, which were included in medical records during a period of up to 20 years.  In addition, (Coroneos et al. 2019) reported that Allergan’s study of 60% of the almost 50,000 women they enrolled in their study submitted to the FDA, physicians’ diagnoses of their patients two years after their implant surgery found statistically significant increases in fibromyalgia, rheumatoid arthritis, and lupus compared to the general population.  Although the Mentor data reported in that study are very flawed, the Allergan data, which were provided to the FDA, seem solid.

Patient Informed Consent Checklist

The Breast Implant Working Group created a checklist that was provided to the FDA in October.  This checklist has been endorsed by the American Society of Plastic Surgeons, the National Center for Health Research, Breast Cancer Action, Our Bodies Ourselves, National Women’s Health Network, Jacobs Institute for Women’s Health, Breast Implant Victims Advocacy, Just Call Me Ray, and Breast Implant Safety Alliance.  It was also supported by more than 77,000 individuals who signed a petition that the Working Group provided to FDA officials on December 9, 2019

We agree with the FDA that the purpose of a patient checklist is to provide information for patients considering breast implants for augmentation or reconstruction, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them. Based on our experience with patients, we urge the FDA to ensure that the checklist is:

  • Brief and easy-to-understand, formatted with information on specific issues that are presented succinctly;
  • Jargon-free. Keep in mind that the average reading level in the U.S. is 6th
  • Organized to focus on the information that patients are less likely to obtain from other sources. It should not start with lengthy sections that are not especially interesting to patients.

Focus and Organization of the Checklist

The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms. It is therefore essential that the checklist provide information that thousands of implant patients have stated they were not warned about.  For that reason, the checklist should not focus on surgical and cosmetic risks, which are the types of risks that all patients are warned about in standard consent forms.  Instead of the almost full page of mostly surgical risks that are listed at the beginning of the FDA’s draft checklist, such risks should be summarized very briefly in one sentence, with the checklist focused on other risks that patients could otherwise not be aware of.  Similarly, cosmetic and local risks should be listed last in the checklist, since that information is more likely to be provided through other means.

The FDA draft checklist starts with “Considerations for a Candidate for Successful Breast Implantation,” cancer risk and a short section on “systemic illness.”  We suggest shorter, more focused headings and information to make the checklist more engaging and easy to read.

Who shouldn’t get breast implants?

The above heading should replace “Considerations for a Candidate for Successful Breast Implantation,’ since that latter heading implies that the patient characteristics listed are the only ones that would reduce the chances of complications or other problems.  In terms of content, the FDA draft wording on who should not get breast implants contains important information but is much too long and includes information that could be summarized.  The goal of the checklist should be to provide the most essential information that patients might not get from standard informed consent forms.  We recommend a short summary regarding active infections, cancer, or wound healing, and the following wording instead:

I understand that the safety of breast implants was never studied for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems and symptoms for these people.  In addition, breast implants may not be safe for anyone with a weakened immune system or certain genetic risk factors that have not yet been identified.

Risk of Cancer: BIA-ALCL (Breast Implant Associated Anaplastic Large Cell Lymphoma)

We recommend that the FDA’s draft wording for BIA-ALCL could be improved as follows:

I understand that there is a small risk for me to develop BIA-ALCL, a cancer of the immune system. BIA-ALCL is a type of lymphoma that develops on or around the scar capsule that surrounds the breast implant. I understand that the symptoms of BIA-ALCL include breast swelling, lumps, pain, and asymmetry that develop after surgical incisions are completely healed, usually years after implant surgery.

Treatment for BIA-ALCL includes removal of the implant and scar capsule, and, if not treated early, may include chemotherapy and radiation. This diagnosis and treatment may be at my own expense and is not always covered by insurance. 

Systemic Symptoms:  Breast Implant Illness

As noted earlier, “Breast Implant Illness” should be the term used, since “systemic symptoms” is not a term that all patients would understand.  Also as noted earlier, the FDA draft guidance and draft checklist consistently imply that the number of women reporting symptoms of breast implant illness is small and that there is no research evidence that the symptoms are caused by their implants.  For example, the FDA’s draft wording that “some women report” implies that a small number of women are claiming an illness that isn’t real.  It is more accurate and meaningful to patients to say that several studies support the apparent causal link to breast implant illness symptoms (Watad et al 2017 and Colaris et al. 2017) and to symptom improvement after implants are removed (DeBoer et al. 2017), for example).  It should also state that the largest, long-term studies also indicate a statistically significant increase in certain autoimmune or connective tissue diseases, as summarized on page 2 of this document, citing Watad et al. 2018 and Coroneos et al. 2019). For that reason, ASPS, researchers, women’s health organizations, and patient groups endorse the following wording:

I understand that because of the lack of long-term safety data, we are still learning about the health problems that result from breast implants.  To date, thousands of women have reported to the FDA or to researchers that they have experienced serious health problems that several studies have linked to their breast implants. This may occur either immediately after getting implants or years later. These often include symptoms such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and skin problems.

Several studies of women with breast implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women:  Chronic Fatigue Syndrome; Multiple Sclerosis (MS); Rheumatoid Arthritis (RA); Sjögren’s syndrome; and Systemic Sclerosis/Scleroderma.

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, several studies indicate that most symptoms improve partially or completely after having their implants and capsules removed.

Breast-Implant Specific Risks

This heading in the FDA’s draft Checklist is misleading, since BIA-ALCL and many other risks of breast implants are specific to breast implants.  More important, this section is much too long and includes too many topic areas.

We therefore recommend the following shorter, more specific sections:

How long do breast implants last?

It’s essential that patients understand what it means when experts say that breast implants “don’t last a lifetime.”  Since many implant patients are young, some think that means they only last 30-50 years.  Even saying “the longer you have them, the more likely they are to break” can be misinterpreted to refer to 30 or 40 years later.  For that reason, the Working Group Checklist specifies “Implants may rupture or leak at any time, and that is more likely the longer you have them” and that “it is likely that I will need other surgeries related to my breast implants over the course of my life.”

The wording should be succinct, explicit, and easy to understand.  Augmentation patients are already aware that their insurance policy does not cover cosmetic surgery, but it is important for them to also know that insurance is unlikely to cover subsequent surgeries due to complications or breakage, since they might mistakenly assume that problems related to implants will be covered even if the initial cosmetic surgery is not.  We recommend the following wording:

I understand that breast implants are not expected to last for the rest of my life.  Implants may rupture or leak at any time, and that is more likely the longer you have them.  In addition, it is likely that I will need other surgeries related to my breast implants over the course of my life.  If I am a cosmetic surgery patient, my health insurance policy may refuse to cover these surgeries for removal, and probably would not cover replacement. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other procedures. I understand that undergoing multiple surgeries may increase my chances of permanent breast deformity.

Chemicals and Metals in Breast Implants

Patients should be informed about the chemicals and metals in the specific make and model of breast implants they are considering.  Since the checklist is for all breast implant patients, it should include a brief, general statement about chemicals and heavy metals, but each patient should get separate, more detailed information about the specific model of implant they are considering.  We recommend the following wording for the checklist:

I understand that all breast implants contain chemicals and small amounts of heavy metals that may cause health problems. I understand that most of these chemicals are confined to the shell of the implant or stay inside the shell.  However, small quantities have been found to diffuse (bleed) from or through the implant shell, even if the implant is intact and not ruptured.

Rupture and Leakage

Patients would benefit from a section with a heading of “Rupture and Leakage.”  Although this overlaps with the issue of how long implants last, more specific information about silent rupture is important.  We recommend the following wording for the checklist, understanding that if FDA no longer recommends MRIs after 3 years, that wording should be revised, but the explicit information about the risks of silicone migration should be included:

I understand that the longer my breast implants are in place, the more likely they are to rupture, especially after the first few years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by mammogram, MRI, or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs often are not covered by health insurance. I understand that silicone may migrate from the implant into nearby tissues such as the chest wall, lymph nodes, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, it is currently recommended that any ruptured silicone implant should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Capsular Contracture

Capsular Contracture is a common complication that therefore should have its own heading.  Our recommended wording is as follows:

I understand that one of the most common complications of breast implants is when the scar tissue capsule that forms around the implant hardens. In some cases, this can be quite painful, distort the shape of the breast, and can make mammography more painful and less accurate. Removing the implant and capsule without replacing the implant is the only recommended way to guarantee that this problem is corrected.

Breast Cancer

Breast cancer issues should be a separate heading in the checklist, not part of the section on ACLC, in order to avoid confusion.  Our recommended wording is as follows:

I understand that all breast implants can interfere with mammography and breast exams, possibly delaying the diagnosis of breast cancer. I understand that if I get breast implants, I should inform the mammography technologist about the implants and ask for additional views to improve the accuracy. I understand that mammography can also cause the breast implant to rupture or leak.

Interference with Breastfeeding

Since the data are lacking, our recommended wording is as follows:

I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.  No long-term research has been conducted to determine the possible transmission of chemicals and heavy metals in the breast milk of women with implants.

Loss of Sensation to Breast or Nipple(s)

Many women do not understand that breast implant surgery can cause loss of sensation.  While more likely among reconstruction patients, it is important to note that augmentation patients can also experience loss of sensation or painful sensitivity.  We therefore recommend this wording:

I understand that breast implants and breast surgery may cause the nipple or breast to be painful, or to have decreased sensation. These changes may be temporary or permanent, and may affect sexual response or the ability to nurse a baby.

Cosmetic Complications

Cosmetic complications should be the last section of the checklist, because like surgical complications they are often included in standard informed consent documents.  We recommend the following brief, easy to understand, but explicit warnings, such as using the term “sag” instead of ptosis:

I understand that if my breasts had slightly different shapes before surgery, they may remain slightly different after surgery. I understand that the implants may cause the breasts to look slightly different in size or shape. I understand that the implant may move from the original placement location and that may result in asymmetry or other cosmetic problems. Breast implants can cause the breasts to sag over time due to the weight of the implants. I understand that if I am not happy with the results, I may need future surgeries to improve the appearance of my breasts.

 

FOOTNOTES:

Colaris MJ, de Boer M, van der Hulst RR, Cohen Tervaert JW. (2017) Two hundred cases of ASIA syndrome following silicone implants: a comparative study of 30 years and a review of current literature. Immunologic Research 65(1):120-128. doi: 10.1007/s12026-016-8821-y

Coroneos C, Selber J, Offodile A, et al. (2019) US FDA breast implant postapproval studies: Long-term outcomes in 99,993 patients. Annals of Surgery 269(1):30-36. doi: 10.1097/SLA.0000000000002990

De Boer M, Colaris M, van der Hulst RR, Cohen Tervaert JW (2017) Is explantation of silicone breast implants useful in patients with complaints? Immunologic Research 65(1):25-36. doi: 10.1007/s12026-016-8813-y

Watad A, Quaresma M, Brown S, et al (2017) Autoimmune/inflammatory syndrome induced by adjuvants (Shoenfeld’s syndrome)—an update. Lupus 26(7):675-681. doi:10.1177/0961203316686406

Watad A, Rosenberg V, Tiasano S. et al. (2018) Silicone breast implants and the risk of autoimmune/rheumatic disorders: A real-world analysis. International Journal of Epidemiology. 47(6):1846-1854. doi: 10.1093/ije/dyy217

 

 

Roundup 2019: Breast implants, mesh, paclitaxel-coated devices among hot topics at FDA expert panels

Helpful Articles

One undercurrent: Inadequacy of post-approval studies and spotty adverse event reporting, leading to incomplete data with which panelists could form opinions.

It was a busy year for FDA’s expert advisory committees, called on to tackle many of its biggest medical device questions in 2019, new and old.

[…]

Repeated meetings aren’t necessarily a negative, said Diana Zuckerman, president at the National Center for Health Research since 1999.

“We can’t think of these public meetings as a bad outcome … We wish that people weren’t being harmed by breast implants, by mesh, by Essure, and so on. But if they are being harmed, then I’d much rather there be a public meeting about it then to have it covered up,” Zuckerman said. “For breast implants especially, it’s made an enormous difference in terms of public awareness.”?

[…]

Read original story here.