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FDA Will Not Ban Textured Breast Implants at this Time

Lauren Dunn, NBC News: May 3, 2019.


Almost one month after an emotional hearing on breast implant safety, the Food and Drug Administration announced it would not ban textured breast implants, which have been linked to a type of lymphoma.

Allergan’s textured implants have already been yanked off the market over safety concerns in 38 countries, including France and most recently Canada. But the FDA said Thursday there isn’t enough evidence to warrant a ban in the United States.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard set forth in the Federal Food, Drug, and Cosmetic Act,” the agency said Thursday.

The implants, which have a rough, sandpaper-like surface, are linked to breast implant associated-anaplastic large cell lymphoma or BIA-ALCL, a cancer of the immune system that can be deadly if it’s not treated early enough. In the United States, 457 women have been diagnosed with the disease. Worldwide, 17 have died.

“This disease is still so grossly underestimated and we will continue to see more deaths and diagnosed women,” Michelle Forney, who was diagnosed with BIA-ALCL last year, said. “However, not banning textured implants because it doesn’t meet a banning standard from a legislative act gives me more concern that our country cannot protect us or our children from other cancer-causing devices.“

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning — the FDA’s strictest caution.

Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

“We are considering these actions to help to ensure that all women who consider breast implants have the information they need to have thoughtful and balanced discussions with their health care professional about both the benefits and risks of breast implants based on clear information reflecting the most current understanding of these issues,” the FDA said in a statement.

Critics fear the moves don’t go far enough to protect women.

 

See the original story here.

Breast Implants Linked to Rare Cancer Get OK to Stay on U.S. Market

Storm Gifford, New York Daily News: May 2, 2019.


A type of breast implant that has been linked to a rare cancer form will not get pulled from the American market.

That was the Food and Drug Administration’s decision on Thursday, which claimed its risks didn’t warrant a countrywide prohibition.

But the agency was mulling issuing a strong warning for the implants and requiring manufacturers to strictly report any potential problems.

Recently, regulators have contended with the recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health woes attributed to the implants.There have been more than 600 documented cases of the cancer worldwide, among an estimated 10 million women with implants.

The announcement is the latest in a decades-long effort to manage implant risks and complications that can include scarring, pain, swelling and rupture, reported The Associated Press.

Although the FDA says it doesn’t have concrete proof that implants are harmful, women considering getting them “should be aware of these risks.”

French officials recently issued a ban of breast implants associated with a form of lymphoma, including those sold by Allergan. But the FDA’s director for medical devices said he won’t take that step yet.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard,” said Dr. Jeffrey Shuren.

President of the National Center for Health Research Diana Zuckerman, who has studied breast implant safety, said a ban may not be needed to phase out textured ones.

“I think a lot of physicians are going to avoid them and patients are going to say they don’t want them, said Zuckerman.[…]

See the original story here.

80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.

Editorial Board, The New York Times: May 4, 2019.


When the Food and Drug Administration announced last month that it couldn’t guarantee the long-term safety and efficacy of vaginal mesh products — medical devices that have been on the market for decades — the collective response from tens of thousands of women harmed by the products sounded something like this: Duh.

The mesh, which is used to hold pelvic organs in place when muscles become too weak to do the job, has long been tied to life-altering injuries, including nearly 80 deaths as of 2018. In the past decade, seven companies have spent a collective $8 billion to resolve more than 100,000 patient claims — making litigation over vaginal mesh (or pelvic mesh, as it is sometimes called) one of the largest mass tort cases in United States history. As those lawsuits have made clear, most of these medical devices were approved for market with nearly no clinical data.

It seems incredible that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy. But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.

Problems can take years to emerge and can be impossible to correct, in part because permanent implants are not easily extracted from the body. (Removing mesh from pelvic tissue has been likened to removing chewing gum from long, thick hair). When trouble does arise, device makers often equivocate, regulators dither and patients seeking redress are forced into lengthy and expensive court battles. In the end, faulty products can remain on the market for years.

The F.D.A. finally pulled the remaining vaginal mesh products off the market last month (although most companies had already stopped selling them because of all those lawsuits). But on Thursday, the agency said it would not ban a breast implant linked to a rare form of cancer and so many other side effects that doctors have coined a new term — “breast-implant illness.” Like mesh, the breast implant was approved years back, based on meager safety evidence. Regulators now say there is not enough proof of harm to justify reversing that decision.

The risks of waiting loom large: In the past decade, nearly two million injuries and more than 80,000 deaths have been linked to faulty medical devices, many approved with little to no clinical testing, according to a global investigation by the International Consortium of Investigative Journalists.

Women are particularly well acquainted with this cycle. Essure, a permanent birth control device consisting of two metal coils injected into the fallopian tubes, has been linked to autoimmune disorders and more than 800 pregnancy losses. The product was pulled from the market last year —  by the device maker, which cited declining sales, not by the F.D.A. And the power morcellator — a spinning blade that shreds uterine tissue so it can be more easily extracted from the body — has proved deadly for some women, whose cancer was spread by the device. As The Times has reported, the morcellator was widely used for 20 years before regulators realized there was a problem.

But that’s not to suggest that only women are affected: There have been metal hips that released poisonous debris into the body, implantable defibrillators that shock people at random (causing indescribable terror) and artificial heart valves with questionable shelf lives. In operating rooms, there have been staplers that misfire; temperature control machines that spray bacteria into open chest cavities; and robotic surgeons that slap, burn and, in some cases, maim patients.

In every one of these cases, a combination of dubious regulatory approvals, skimpy post-market surveillance, and faltering responses from regulators caused irrevocable harm that might have been avoided.

After searing investigations by journalists and patient advocates, the F.D.A. has promised to make “transformative” changes to medical device regulation. But so far, the agency’s suggestions have been meager at best. And in the meantime, regulators have accelerated the device approval process, not slowed it down.

Dr. Jeffrey Shuren, head of the agency office in charge of device regulation, has suggested that the benefits of bringing innovative products to market quickly are worth the increased risks.

It’s true that devices have restored hearing, vision and the ability to walk and have provided many other benefits to millions of people. But the drive to innovate does not justify the growing catalog of medical device disasters. Patients should not have to wonder whether devices will save their lives or destroy them. Reasonable changes could greatly improve the current system.

Tighten approval standards. Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “updated” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. Eight years ago the Institute of Medicine advised the F.D.A. to abolish at least one of these loopholes, what’s known as the 510(k) pathway. It’s past time for the agency to heed that advice, and to ensure that no medical device intended for permanent residence inside a human body is used on patients without first being rigorously tested.

Fix post-market surveillance: Industry proponents say that medical devices can be brought to market quickly and safely by having companies conduct rigorous testing after products go to market instead of beforehand. But companies often fail to complete such studies, even when they’re ordered by regulators. What’s more, device makers frequently skirt rules requiring them to report publicly all incidents of malfunction, injury or illness — often through mechanisms that the F.D.A. itself created. And after years of wrangling, the industry and its regulators have still not fully put a system in place to better notify patients of product recalls and other safety issues.

The F.D.A. has vowed to fix some of these lapses. They’ve promised to abolish reporting exemptions that keep safety issues hidden from the public and to promote breast implant registries that monitor patient outcomes.

That’s a good start, but more can be done. An industry that prides itself on innovation, and earns some $400 billion in annual revenue, should be well equipped to build a global medical device registry where patient outcomes for all medical devices are openly monitored, and where doctors and patients can log concerns and obtain information.

Loosen industry’s grip. Dr. Shuren reportedly referred to device makers, not consumers, as his office’s main customers at a recent industry gathering. As misguided as that statement may sound, he’s not wrong: The medical device industry funds 35 percent of the office’s work, and by law, that funding is contingent upon the agency’s approving devices quickly, and through the least restrictive pathway possible.

It’s not solely those laws that give medical device makers influence over regulators. The industry maintains a well-oiled revolving door with the F.D.A. — as The Associated Press has noted, the last four people to hold Dr. Shuren’s position have gone on to lucrative industry gigs. Device makers also spent more than $300 million lobbying Congress in the decade ending in 2017, according to the Center for Responsive Politics. What’s more, they pay doctors and hospitals hundreds of millions in consulting fees every year, according to the National Center for Health Research. None of this violates any rule, but all of it contributes to the current crisis.[…]

See the original article here.

Breast Implants Tied to Rare Cancer to Remain on US Market

Mathew Perrone, Associated Press: May 2, 2019.


This AP story appeared in media outlets across the country, including yahoo.com and WTVD.com and in the Orlando Sentinel and NY Post.

U.S. health authorities will allow a type of breast implant linked to a rare form of cancer to stay on the market, saying its risks do not warrant a national ban.

But the Food and Drug Administration said Thursday it is considering bold warnings for the implants and requiring stricter reporting of problems by manufacturers. The announcement is the latest in the government’s decades-long effort to manage implant risks and complications that can include scarring, pain, swelling and rupture.

In recent years, the FDA and other regulators around the world have grappled with the recently confirmed link to a rare cancer and the thousands of unconfirmed complaints of other health problems that women attribute to the implants, including arthritis, fatigue and muscle pain.

FDA regulators said in a statement that while they don’t have definitive evidence that implants cause those chronic ailments, women considering implants “should be aware of these risks.” To that end, the agency said it will consider adding a boxed warning — its most serious type — to breast implants and a checklist describing various potential harms for patients considering them.

Earlier this month, French authorities issued a rare ban of breast implants associated with a form of lymphoma, including those sold by manufacturer Allergan. The FDA’s director for medical devices said the agency wasn’t ready to take that step.

“At this time, the FDA does not believe that, on the basis of all available data and information, the device meets the banning standard,” Dr. Jeffrey Shuren said in a statement.

The cancer tied to implants is not breast cancer but lymphoma that grows in the scar tissue surrounding the breasts. Almost all confirmed cases involve a type of textured implant designed to prevent slippage and to minimize scar tissue.

Shuren said that variety accounts for less than 10% of the U.S. market, which is primarily smooth implants. He noted there have been cases of the cancer with smooth implants, raising questions about whether multiple factors contribute to the disease.

There have been more than 600 cases of the cancer worldwide, among an estimated 10 million women with implants.

Diana Zuckerman, who has studied breast implant safety, said a ban may not be necessary to phase out textured ones.

“I think a lot of physicians are going to avoid them and patients are going to say they don’t want them,” said Zuckerman, president of the nonprofit, National Center for Health Research, which evaluates studies and conducts its own research.

Breast augmentation is the most popular form of cosmetic surgery in the U.S., with roughly 300,000 women undergoing the procedure each year. Another 100,000 women receive implants for breast reconstruction after cancer surgery.

In a move to “promote greater public transparency,” the FDA also said Thursday that breast implant manufacturers will no longer be permitted to summarize routine injuries and complications in bulk reports. Manufacturers are required to report all serious injuries, malfunctions and deaths related to their devices. But under the FDA’s alternative summary reporting program, breast implant makers and other manufacturers could file quarterly updates representing thousands of incidents, most of which were not listed in a public database.[…]

See the original story here.

FDA Allows Breast Implants Linked to Rare Cancer to Remain on the Market

Marie McCullough, Philadelphia Inquirer: May 2, 2019.


The U.S. Food and Drug Administration on Thursday announced that it will not ban textured breast implants that can cause a rare cancer, but the agency is considering steps to ensure that women and doctors are informed of the risks of the device.

During a two-day public meeting on implant safety last month, scores of women implored an FDA advisory panel to end marketing of rough-surfaced implants, which have been linked to breast implant-associated anaplastic large-cell lymphoma, a type of cancer that typically begins with swelling in the breast.

Several countries, including Canada, France, and the Netherlands, have halted or restricted textured implant sales, but the FDA advisers rejected the idea.

On Thursday, FDA officials said existing scientific evidence does not legally justify a ban. They pointed out that textured implants make up only 10 percent of the U.S. market, and that the lymphoma has developed in a small number of cases in which the implant surface was smooth or unknown.

While refusing to restrict sales, the FDA for the first time conceded that implants may cause systemic symptoms such as chronic fatigue, cognitive problems, and pain. Many women testified last month about what is now called “breast implant illness,” but the link has been debated since silicone gel implants were introduced in the 1960s.

“While the FDA doesn’t have definitive evidence … the current evidence supports that some women experience systemic symptoms that may resolve when their breast implants are removed,” the statement said. “We believe women considering a breast implant should be aware of these risks,” the FDA statement said.

The FDA said it is considering requiring a “black box warning,” its strongest safety warning, on breast implant labeling. It may also require something women have pushed for: a check-list of risks that doctors and implant patients would have to review and sign.

The agency also said it has required companies to submit individual reports of complications or harms attributed to implants, rather than “summary reports,” which lump the problems together and omit details.

Diana Zuckerman, president of the National Center for Health Research and a presenter at last month’s hearings, called the FDA’s rejection of a sales ban “unfortunate,” but said the steps to improve reporting of problems and informed consent are “important.”

On the issue of breast implant illness, she asked whether the FDA will “require the research needed to provide the definitive proof the FDA says is lacking.”

Jamee Cook, 41, of Dallas, who suffered severe symptoms until she had her implants removed in 2015, co-founded a Facebook group devoted to breast implant lymphoma and gave an impassioned presentation at the March hearings.[…]

See the original article here.

FDA Won’t Ban Breast Implants Linked to Cancer at This Time

Laurie McGinley, Washington Post: May 2, 2019.


A month after a dramatic hearing in which many women called on the Food and Drug Administration to ban a type of breast implant linked to a rare cancer, the agency said it won’t take that action now but will increase efforts to collect and disseminate information about risks involving the device.

The FDA does not believe that the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information, according to a statement issued Thursday by Amy Abernethy, FDA principal deputy commissioner, and Jeff Shuren, director of the agency’s Center for Devices and Radiological Health.

Some other countries have banned or restricted sales of certain textured implants because of concerns about what’s called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

Some of those devices are not sold in the United States, the FDA said. In addition, while textured implants make up as much as 80 percent of the market share in some other countries, they represent only 10 percent or less of the implants sold in this country, the agency said.

The majority of women who develop the implant-related cancer have textured implants, but there are some cases in which cancer patients have implants with smooth surfaces, the FDA said. And in many of the lymphoma cases, the agency doesn’t know whether the implants were smooth or textured.

As of last Sept. 30, the FDA had identified 457 cases of implant-related lymphoma and nine deaths worldwide. The American Society of Plastic Surgeons reported 16 disease-related deaths worldwide as of Jan. 1, 2019.

The FDA officials also addressed “breast implant illness” a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue — a topic that was repeatedly raised at the March hearing. The agency said it “doesn’t have definitive evidence demonstrating breast implants cause these symptoms,” but added that evidence supports “that some women experience systemic symptoms that may resolve when their breast implants are removed” — and that women should be made aware of the risk before getting implants.

That statement, said Diana Zuckerman, president of the National Center for Health Research, is the closest the FDA has come to acknowledging breast implant illness. “That’s definitely progress,” she said. She added she was disappointed the FDA didn’t ban certain textured implants, but said it wasn’t surprising since the agency has only banned two devices in its history — powdered surgeons’ gloves and prosthetic hair fibers.

At the two-day hearing before an FDA advisory committee in late March, women who said they had been harmed by implants demanded the agency take new steps to protect consumers, including providing more information about risks and banning certain devices. Many said that they weren’t given adequate information about possible problems before getting implant surgery. Committee members echoed their concerns, urging the agency to ensure patients have a clearer understanding of the risks.

Responding to such concerns, the agency said it is considering requiring implants to carry what’s called a boxed warning — the agency’s strongest safety warning. And it may require doctors and patients to sign checklists of risks to make sure women have the necessary information to make an informed decision.

Jamee Cook, who had her breast implants removed in 2015 and co-founded Breast Implant Victim Advocacy, said she was ?very disappointed” that the FDA did not ban the textured devices. But she said she was pleased by the agency’s other steps.[…]

Read the original article here.

NCHR Public Comment to FDA on Breast Implant Safety

National Center for Health Research, April 26, 2019


National Center for Health Research Public Comment on General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting [FDA-2019-N-0426].

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery
Devices Panel of the Medical Devices Advisory Committee meeting on breast implants. The
National Center for Health Research is a nonprofit research center staffed by scientists, medical professionals, and health experts focused on research, programs, services, and policies that affect public health. Our Center analyzes scientific and medical data and provides objective health information to patients, providers, and policymakers. We do not accept funding from companies that make medical products, so we have no conflicts of interest.

Our Program to Help Women Seeking Insurance Coverage for Implant Removal

Since its founding in 1999, our Center has heard from thousands of women who told us that their breast implants have caused serious health problems. In 2015, we began to offer a program that helps women navigate their health insurance policies so that they can get coverage when the removal of breast implants is medically necessary. In the past 3 years, more than 6,000 women have contacted us, and the number continues to grow dramatically. Some weeks we are contacted by more than 200 new women seeking our help to get their breast implants removed because of serious medical problems. Their reasons for needing their implants removed include leaking and ruptured breast implants, chronic pain from capsular contracture or from implants that are too large, autoimmune or connective tissue symptoms or diseases (referred to as “breast implant illness”), and ALCL. Some women contact us after recently developing symptoms from their breast implants, while others have been living with chronic health issues for years but either did not know they might be related to their breast implants or did not have the financial resources to have their implants removed. Prior to passage of the Affordable Care Act, breast implants were considered a “pre-existing condition” and explant surgery was almost never covered by health insurance.

Most women tell us that had they known that breast implants might cause these serious health problems, they never would have gotten them. We hear every day how women trusted their doctors when they were told that breast implants were safe and that complications were rare.

Recent research on 123,255 Israeli women by Watad et al. concluded that breast implants
significantly increase the chances of a woman being diagnosed with several autoimmune
diseases, such as rheumatoid arthritis and Sjogren’s Syndrome. However, because the FDA has repeatedly denied a link between autoimmune or connective tissue symptoms and breast implants, insurance companies will rarely pay for the removal of implants for women with symptoms of breast implant illness, such as joint or muscle pain, chronic fatigue, mental confusion, rashes, hair loss, and persistent flu-like symptoms. Of the thousands of women who seek assistance from our organization, only about 20% are able to get their implants removed. Even fewer get insurance coverage for their medically necessary explant surgery. The rest have to empty their savings, rely on credit cards or loans, or borrow money from friends and family. Unfortunately, most women who are unable to get insurance coverage for their breast implant removal are also unable to afford to pay out-of-pocket for explant surgery, which is why so many live with debilitating symptoms and escalating health problems for years. What might start as gradual increases in symptoms become so debilitating that many of the women lose their jobs (and with it, often their insurance), their ability to care for themselves or their families, and sometimes their spouses.

Implications for the Registries

The PROFILE Registry is intended to gather information about patients with BIA-ALCL, but not other health problems. The National Breast Implant Registry is designed to include as many Board-Certified plastic surgeons and their patients as possible, and therefore focuses only on re-operations – information that is relatively easy for physicians to document. It does not include information about the range of life-changing symptoms that thousands of women have reported, and also fails to include the thousands of women who need to have their implants removed, but are financially unable to do so. As we have found in our program assisting women who desperately seek insurance coverage for explant surgery, the number of women who have their implants removed and not replaced is only a small percentage of the number of women who want explant surgery because of medical problems. The registry needs to be substantially improved by including information about the autoimmune and connective tissue disease diagnoses as well as the moderate to severe symptoms that women refer to as breast implant illness. In addition, registries need to include information from primary care physicians and non-surgical specialists who are often conducting medical tests in an effort to determine the cause of the women’s symptoms. Most women who experience autoimmune or other symptoms from their breast implants are making appointments with primary care physicians, rheumatologists, neurologists, and other specialists; they rarely return to their plastic surgeons because those symptoms aren’t clearly related to their implants. Moreover, they tell us that when they go to a plastic surgeon because they have heard from other patients that the symptoms may be related to their implants, most surgeons tell them they are mistaken.

Another major shortcoming of the current Registry is that the data from the Registry is not
available to researchers or the public unless the ASPS Foundation chooses to make it public. Since the FDA considers registries an important aspect of post-market surveillance, it is essential that the data be available to anyone who wants to analyze it.

If Implants Can Cause Serious Symptoms, Will Removal Improve Health?

Our Center recently conducted a study of 449 women who had sought our help and succeeded in having their implants removed in 2016, 2017, or 2018. Fifty-seven percent of the women filled out our online questionnaire, all between November 2018 and January 2019. All of the women who we contacted had provided medical information to us when we had previously tried to help them obtain insurance coverage for explant surgery. Fifty-nine percent of the women in the study had symptoms for more than 5 years before they had their breast implants removed and 25% reported having symptoms for more than 10 years before explant surgery. These findings are consistent with patients’ testimony at the FDA meeting and with what thousands of patients have told us over the years: Many women have had debilitating symptoms for years, but did not know they were linked to their breast implants. So, instead of removing their implants when they first noticed health problems, they waited years, and sometimes decades, to seek explant surgery without replacement. Whether because of lack of money or lack of information that their symptoms were caused by their implants, our findings suggest that a short, easy-to-understand booklet and informed consent checklist could help warn women with limited financial resources about the risks of breast implants and also help women recognize their symptoms and consider explant surgery as an option before their health deteriorates.

We asked about family and personal health history and found that 69% of the women in our study reported a family history of autoimmune disease, 3% reported a personal history of autoimmune symptoms prior to getting implants, and 51% of the women reported that they were newly diagnosed with an autoimmune disease after getting breast implants.

Using a Likert scale with responses ranging from “much worse” to “much better,’ 61% of the women reported that their symptoms were much better since getting their implants removed and an additional 29% reported that their symptoms were somewhat better after having their breast implants removed. After performing a logistic regression to determine the factors that independently predicted health improvement after explant surgery, having explant surgery that removed as much capsule as possible predicted improvement after explant, as did not having a family history of autoimmune disease.

Implications for Informed Consent

Although all implant companies have patient booklets, in our experience most women report never seeing those booklets. In addition, the booklets are much too long and technical; they range in length from 55 to 180 pages, and include a great deal of information that is difficult to understand or promotional rather than informational. Nevertheless, the patient booklets include important information, such as the warning that breast implants were not studied on women with a history of autoimmune disease and therefore the safety of implants is not established for those women. However, there is so much information in these lengthy booklets that these types of important warnings are unlikely to be noticed by either doctors or patients that read them.

Although all patients sign an “informed consent” document, many are too technical for the
average patient to understand and include information that may be vague or confusing. They are often signed without having been carefully read. Informed consent is supposed to be a process, not just a piece of paper. Patients tell us that regardless of what the informed consent forms stated, their plastic surgeons were very reassuring about how safe implants are, rather than being candid about the risks. At the FDA Advisory Committee meeting on March 25-26, many plastic surgeons spoke about how carefully they provide informed consent to their patients, but those claims were undermined by the fact that many of those same surgeons stated that their patients are very happy with their implants, that ALCL is very rare and ‘not a big deal’ if caught early, and that the symptoms of breast implant illness are the same symptoms that all women tend to have. It is obvious that these physicians are unable to provide objective, informed consent about risks if they think the risks are minimal or non-existent.

Improving Informed Consent

Women need better informed consent in terms of written material and in terms of what their physicians tell them. Patient booklets specific to each company and implant model should be no longer than 20 pages and written at an 8th grade reading level, which is the reading level recommended by health educators. They should include easy-to-understand information about complications and risks, including information about BIA-ALCL and symptoms of breast implant illness. They should also include information from studies indicating that many women with breast implant illness experience significant improvement when their implants and scar capsules are removed. The writing of these booklets should require consensus among a group of experts that includes patients harmed by implants and their physicians, Board-certified plastic surgeons who put in breast implants and Board-certified plastic surgeons who primarily explant, the relevant implant manufacturer, and health educators.

In addition, there should be a required checklist, no longer than 3-4 pages, that is similar to the one that the FDA required for Essure, that provides information about the potential risks of all breast implants including BIA-ALCL and breast implant illness. These should be read and signed by patients and their doctors prior to any nonrefundable deposits for surgery. The checklist should include a black box warning regarding BIA-ALCL and breast implant illness, and information about the potential improvement in health for women who have their implants removed and not replaced.

In conclusion, we urge the FDA to require an informed consent checklist that specifically and succinctly warns of the symptoms and disease development risks that the patients at this meeting have reported. We ask that the FDA require manufacturers to complete the large, long-term studies that evaluate systemic symptoms. And finally, we urge the FDA to develop a national registry that includes symptoms as well as re-operations.

Thank you for the opportunity to comment on this important issue.

For more information, please contact Diana Zuckerman, PhD, at dz@center4research.org.

Public Comments by Women’s Health Experts on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting


National Center for Health Research Public Comment on General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

Thank you for the opportunity to provide comments on FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting.

We are writing on behalf of five nonprofit health organizations that have examined issues pertaining to women’s health for decades and have considerable expertise concerning breast implant safety issues. None of these organizations have financial or professional conflicts of interest pertaining to breast implant devices or surgery:

  • Breast Cancer Action is a national nonprofit grassroots membership organization with members across the country who are challenging the status quo and working to address and end the breast cancer epidemic.
  • The Jacobs Institute of Women’s Health identifies and studies aspects of healthcare and public health, including legal and policy issues, that affect women’s health at different life stages.
  • The National Center for Health Research is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety.
  • The National Women’s Health Network (NWHN) is a non-profit advocacy organization that works to improve the health of all women by supporting informed consumer decision-making.
  • Our Bodies Ourselves is a nonprofit educational and advocacy organization that has advanced the health and human rights for girls and women for almost 50 years.

As a follow-up to the FDA’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting on breast implants, we are writing to express our views and concerns about the current status of information about breast implants and the role of the FDA in regulating the devices.

1. There is insufficient research to determine the long-term safety of breast implants. The clinical trials submitted to the FDA have numerous shortcomings:

  1. They excluded women with a history of autoimmune disease.
  2. They had an unacceptably high “loss to follow-up.” At the FDA meeting, FDA scientists presented data from studies that had lost up to 85% of the patients to follow-up, even in the revised studies that had already eliminated the 95% of patients who had dropped out. Those revised studies were already hopelessly biased, and presenting the data as if it were meaningful was unacceptable. And, the numbers of patients were also unacceptably small in many cases, with several reconstruction and revision patient groups represented by less than a dozen patients. Accurate information on the safety of breast implants cannot be gleaned from studies with such inadequacies.

The studies of autoimmune and connective tissue disease funded by industry and plastic surgeons had a different set of problems:

  1. Many included small number of patients, some of whom had breast implants for short periods of time, ranging from one month to just a few years. This is not relevant to long-term safety issues, since implants tend to deteriorate and rupture over time.
  2. They evaluated the number of women with diagnoses of rare diseases, but did not include women with symptoms of those diseases, nor did they have the statistical power to evaluate significant differences between women with implants and women without implants.
  3. Many evaluated the number of women hospitalized with those rare diseases or whose medical records specified those diseases, but the studies included women who had implants for such a short time that it was unlikely that the women had yet been diagnosed or hospitalized.

2. Most women do not receive objective informed consent regarding the risks of breast implants during the decision-making process. When the FDA approved breast implants, the agency required that plastic surgeons share information about the risks in a patient booklet. Unfortunately, most women say that they do not receive these booklets prior to surgery, and the booklets themselves are too long and complicated to provide useful information to patients. For example, although the patient booklets warn that the safety of breast implants have not been studied in women with a history of autoimmune disease, that information is difficult to find in these 44-202 page patient booklets.

3. To improve informed consent, women considering breast implants need a shorter, easy to understand patient booklet, which harmed patients should help to write. These booklets should include quantitative data on risks of the company’s implants for augmentation patients and reconstruction patients that are easy to understand. As experts in educating women on health issues, we would be glad to participate in writing these booklets as well. In addition, we strongly urge that the FDA require a short, user- friendly check list that provides balanced information about the risks, similar to the 3- page check list that the FDA required doctors and their patients to sign to inform them of the possible risks of Essure. The current informed consent checklists provided by some implant companies are vague consent forms rather than specific information acknowledging the risks. Informed consent checklists should explain all of the associated risks, encourage informed and shared decision making by the patient, and ultimately prevent long-term harm. It should clearly and succinctly state the risks that can occur with breast implants, including BIA-ALCL, the possibility of autoimmune symptoms, the need to remove the implants as they age and rupture, and the cost of MRI screening for silent rupture. The checklist should include a black box warning about BIA-ALCL and breast implant illness. The checklist should also include information based on studies indicating that women with breast implant illness are significantly more likely to improve after their implants and capsules are removed.

4. Since almost all cases of BIA-ALCL are associated with textured breast implants, implant companies that make textured implants should be required to conduct large retrospective studies to evaluate if the implants have any benefits compared to smooth implants. Some plastic surgeons believe that textured implants are less likely to cause capsular contracture and some other problems, but the FDA has not vetted any data to support those claims. Similarly, the use of mesh in breast reconstruction has not been scientifically studied to determine risks or benefits, and FDA should add warnings to the label and the FDA website about that off label use. In the meantime, textured breast implants should carry a black box warning about BIA-ALCL and that information should be provided orally and in writing to all women considering implants.

5. The newly designed breast implant registry tracks only the rates of reoperation, not other complications or health problems of women with breast implants. In addition, the National Breast Implant Registry misses the thousands of women who need to have their implants removed, but are financially unable to do so. To provide useful information, the registry should include information about important, debilitating autoimmune and connective tissue disease symptoms associated with implants. Registries should include relevant medical information from physicians other than plastic surgeons. In addition, the data from the registry are not available to the public unless the plastic surgeons chose to publish information. To improve transparency and informed decision- making by physicians and patients, data from the registries should be made available for free to the FDA, independent researchers, and the public to be analyzed and published.

6. We strongly urge the FDA to require manufacturers to complete large, long-term studies that evaluate the serious symptoms that patients described at the FDA Advisory Committee meeting. Well-designed studies were required as a condition of approval more than a dozen years ago, but those studies were not properly completed, due to enormous loss to follow-up. The FDA should require such studies now, and this time the research requirements should be enforced and implants taken off the market if the studies are not completed as promised.

In summary, the lack of good data, the lack of informed consent, and the lack of unbiased information for women who have become seriously ill from their breast implants are major shortcomings that FDA can help to remedy. We would be glad to share our expertise with you. Please feel free to contact the leaders of our organizations for additional information: Ms. Karuna Jaggar, Dr. Susan Wood, Dr. Diana Zuckerman, Ms. Cynthia Pearson, and Ms. Judy Norsigian.

Lisa Rohland


Mesa, Arizona

I’m Lisa Rohland, a Surgical Technologist and First Assistant for the past 24
years from Mesa, Arizona and founder of the Arizona Breast Implant Illness
and Information Facebook page. In just eight months, I’ve helped over five
hundred sick women connect with each other and find qualified explant
surgeons.

Informed consent is the most important conversation patients have with their
surgeons. We must improve the consent procedure for breast augmentation
with implants.

Few patients are health literate. The consent form used by the ASPS is
written at a collegiate level. Reading this thirteen-page form took me 1 hour
and 48 minutes.

At this meeting in 2002, a video-based informed consent process was
suggested that permitted a woman to scrutinize the data from the skeptical,
not the supportive. This is technologically possible now more than ever.
Risks like fatigue, hair loss, migraines, memory loss and autoimmune
disorders may have been minimized in the consent process or the implant
handbook that I never received. I remember my surgeon saying, “These
risks really NEVER happen.” Then he had me sign and initial a single page
consent form acknowledging I “understood” ALL of my risks. I loved my
new saline implants but quickly became ill. I spent years apologizing to my
children with tears in my eyes that I wished I could be the mother they
deserved.

I’ve listened to the testimony of multiple women within the last year that
were part of implant studies. I continued to hear that as soon as adverse
events were reported, patients would receive a letter that they had suddenly been dropped from their study, or were just never contacted again. Several
women were removed just two years into their ten-year study.
We’ve recently learned that women reporting adverse events directly to the
FDA had their data placed into a repository. As a result, all that
information has still not been made public- not to patients, not to doctors,
and not to the media. Transparency regarding adverse events and the
chemicals contained in these implants is essential for women to make
informed decisions.

Patients need to be told about all potential risks to allow for autonomy in
the informed consent process. Otherwise, it is the surgeon and the
manufacturer making the decision on behalf of the patient, regardless of
how small that risk may be.

I would like to help you form an Advisory Committee on informed surgical
consent. This committee should have equal members of physicians,
patients who have been harmed like myself, and members of the FDA, and
other governing bodies. All surgeons should use an independent, engaging
and interactive, web based informed consent by 2020 and review and
update it annually. FDA, you have failed surgeons and patients and this is
your opportunity to make it right. Do your job.

Lisa testified at the FDA Advisory Committee Meeting on breast implants in March 2019.

Nancy Gallegos


California

Hello,

Thank you for allowing me the chance to share my story with your respected panel. My name is Nancy Gallegos. I traveled here from Fresno, Ca. at my own expense, so I have no conflict of interest.

I decided at the age of 24 to get my breast implants. I was young, very vulnerable, and just knew this would change my confidence for the better! Self-esteem was all I wanted.

So I was implanted with Allergan Textured Saline Implants. And if I might add, I am still sick with these today. One might say, “But you look just fine”. For me, this is just a mask. Internally I am suffering.

My health issues started 6 years ago. For many years, I lived symptom free. Until 2013, when all things came crashing down.

The once upbeat, motivated, very confident woman had now turned into a woman who could not get up off her couch, drive her daughter to school, or pass a mandatory test at her job in order to stay employed.

My husband used to describe me as an independent, motivated, and extremely outgoing. Anyone that knows me would say the same. Now he sadly feels this illness has consumed my life. My illness is all I talk about. And he would like the old me to come back! Even though he supports me, I know I’m not the same person he married 10yrs ago.

Today I am asking for proper informed consent. I feel we should be provided very crucial information before implanting, and at that point, the patient can make their own decision whether or not they would like to proceed. One thing I might add is, it’s very difficult going to see your physicians because we are so ill & they have no idea what Breast Implant Illness is. Therefore, many incorrect diagnosis are given with medication prescribed that has no effect.

I myself deal with depression, weight gain, joint pain, insomnia, auto immune disease, Vitamin D Deficiency, anemia, high blood pressure, memory loss, and much much more. I am so thankful a friend directed me to the Breast Implant Illness page, because now I felt like I belong somewhere. These women are dealing with the same issues I have been crying about for years! This page has given me insight as to what no doctor has been able to explain or diagnose. I am a woman in my 40’s that has to walk around with a pill box everywhere I go! Numerous medications with no ultimate effect.

I cannot wait to explant! However, the cost to remove my implants costs almost double what I paid to get them in. Health insurance makes it near impossible to cover. Why do I pay thousands of dollars on an expensive PPO Insurance, yet get denied coverage for explant when i’m extremely ill. I just want my health back!

In closing, I ask you today, to please listen & know we are women in a world of struggle. I would hope that if you had a wife, child, or family member crying out for your help, and they too have breast implants, please listen and know these implants are making women deathly ill, and changing our lives entirely!

Thank you.

Nancy testified at the FDA Advisory Committee on breast implants in March 2019.