Category Archives: News Stories & Editorials

FDA Stops Sales of Transvaginal Mesh for Pelvic Organ Prolapse

Michelle Llamas, Drug Watch: April 16, 2019.

The U.S. Food and Drug Administration has ordered manufacturers of all remaining transvaginal mesh devices for pelvic organ prolapse repair to stop selling their products immediately, according to the agency’s April 16, 2019 press release.

The action comes after the FDA convened an advisory panel on Feb. 12, 2019 to solicit input from experts on how to evaluate the risks and benefits of mesh placed through the vagina for repair of pelvic organ prolapse, a condition in which organs drop into the vagina, usually after childbirth. The controversial implant has been blamed for complications such as severe pelvic pain, bleeding, vaginal erosion and death.

The agency reviewed data provided by manufacturers, and it did not find evidence that transvaginal mesh for POP works better than surgery without mesh to repair weakened pelvic muscles. Thousands of women undergo transvaginal surgery for POP each year, and this order is the latest aimed at protecting these women, the agency said in its press release.

Patient advocates and consumer watchdog groups applaud the FDA’s crackdown on mesh.

“The FDA has made the right decision,” Diana Zuckerman, president of the National Center for Health Research, told Drugwatch in an emailed statement. “Since it is well known that surgical mesh can cause very painful and serious complications, we agree with the FDA that it should not be approved for use in procedures where there are no benefits compared to surgery without mesh.”

The affected mesh devices are Boston Scientific’s Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System and Coloplast’s Restorelle DirectFix Anterior.

The FDA is giving the companies 10 days to submit a plan to withdraw their devices. They must also continue to follow-up with patients who are already enrolled in their 522 clinical trials.

After the FDA reclassified transvaginal mesh for POP as a high-risk device in 2016, the agency required manufacturers to submit new safety and effectiveness data. Most manufacturers, including Johnson & Johnson, simply pulled their devices off the shelves instead of doing additional studies.

That left Boston Scientific and Coloplast.

To continue selling their devices, the companies had to submit a premarket approval (PMA) application with additional data to prove the effectiveness of surgical mesh for transvaginal repair of POP.

“The panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair,” the FDA press release said.

After reviewing the PMAs, the FDA determined manufacturers “have not demonstrated a reasonable assurance of safety and effectiveness.”

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the agency’s press release.

These implants were originally cleared for sale through the controversial 510(k) process, which allows devices on the market without rigorous testing.

“Too many women and men have been harmed by surgical mesh that was allowed on the market without any requirement for clinical trials,” Zuckerman told Drugwatch. “Even when FDA expressed concern about surgical mesh for POP in 2016, too many surgeons continued to use it.”

The FDA began slowly chipping away at mesh after it held its first committee meeting in 2011, and thousands of women have been waging a war against the device for years.

Many have filed lawsuits against mesh makers such as Johnson & Johnson’s Ethicon unit, Boston Scientific and Coloplast. In a 2018 report, 60 Minutes called the consolidated mesh litigation, which includes tens of thousands of lawsuits, “the largest multi-district litigation since asbestos.”

While many advocates laud the FDA for their decision, others claim safety issues don’t end with pulling POP mesh from the market.

Removing POP mesh is a “wonderful start,” patient advocate and mesh survivor Tammy Jackson told Drugwatch. Jackson told her mesh story in the Netflix documentary The Bleeding Edge. She points out that mesh for stress urinary incontinence remains on the market.

“It’s made from polypropylene [like] POP mesh. SUI mesh causes the same complications,” she said. “The problems don’t end with POP mesh being removed.”

She calls on the FDA and medical device industry to “do the right thing” and stop making and marketing pelvic mesh.

Zuckerman says the agency should require clinical trials for all mesh used in surgeries.

“FDA’s finally requiring clinical trials for mesh used for pelvic organ prolapse (POP) was an important first step, but the thousands of patients harmed by surgical mesh clearly show that clinical trials should be required for all types of surgical mesh,” she said.

In the meantime, the FDA has told women who are currently implanted with mesh to continue to see their doctors for routine check-ups. If they are satisfied with their surgery, they don’t need to take action. But women who suffer from vaginal bleeding or discharge, pelvic or groin pain, or pain with sex should notify their health care providers.


See the original article here.

FDA Progressive Device Approval Proposal Raises Eyebrows

David Lim, MedTech Dive: April 16, 2019.

Buried in FDA’s recent 384-page budget justification is a proposal that would upend how the agency approves risky medical devices for life-threatening conditions, empowering regulators with a two-step approval process allowing companies to generate safety and effectiveness evidence after a device is already on the market.

Such a system would automatically sunset the initial approval if a company does not demonstrate appropriate levels of safety and effectiveness. Regardless, the idea within the FDA’s fiscal 2020 budget proposal is raising alarms on Capitol Hill and among patient advocates worried it is the latest example of FDA’s device center being too friendly toward the industry it is tasked with regulating.

“We strongly oppose the proposal because it would greatly weaken an already lax regulatory framework for approving high-risk devices. It’s an unnecessary provision,” Mike Carome, director of Public Citizen’s Health Research Group, told MedTech Dive. “It would allow devices to come to market with some information about safety, but no information about effectiveness.”

Mark Brager, vice president of communications for AdvaMed, told MedTech Dive the proposal “did not come from industry, it was definitely not us.”

The proposal would allow “expedited access to devices that would otherwise be reviewed under the premarket approval or De Novo classifications pathways.”

The idea does have one notable cha​mpion: Jeff Shuren, the director of FDA’s Center for Devices and Radiological Health. In an interview with MedTech Dive, Shuren said the proposal has been “discussed publicly for several years now.”

“Progressive approval is about an appropriate technology coming to market under one regulatory standard but can only remain on the market if it meets a second regulatory standard,” Shuren said. “It is for technologies for which the potential public health benefit is so much greater, for example at least some of the breakthrough devices.”

But a similar approach does not have backing from Shuren’s former boss, Commissioner Scott Gottlieb.

Gottlieb, who stepped down earlier this month, sought to calm concerns among lawmakers that 2018 user fee legislation allowing conditional approval for animal drugs in some cases would set a harmful precedent.

“FDA believes conditional approval offers a unique pathway to address specific challenges of certain aspects of veterinary medicine that human medicine does not face. Therefore, FDA does not believe this pathway would be suitable for human medical products,” he and FDA Center for Veterinary Medicine Director Steve Solomon wrote in a July 2018 letter to HELP Committee Chairman Lamar Alexander, R-Tenn., and Ranking Member Patty Murray, D-Wash.

Gottlieb reaffirmed during his last week as FDA commissioner he believes a stepwise approval should only be used for animal drugs, not human medical products.

“We were very clear that we thought this was a construct that made sense in the context of animal drugs,” Gottlieb told MedTech Dive after his final testimony to Congress. “It wouldn’t make sense in other product areas. We’re not looking to do that, that’s a concept that was narrowly tailored for the purpose of animal drug approvals.”

But Shuren argued the provision has appropriate safety protections given the marketing authorization would sunset without appropriate data being submitted to FDA.

“This may be a very reasonable approach for technology and a responsible way for technology to come to the marketplace under which they still have a strong evidentiary basis to support their marketing with additional postmarket data collection in a timely manner that they need to provide to continue to demonstrate there’s a reasonable assurance of safety and effectiveness. And if not, the marketing authorization would sunset. It puts teeth in the postmarket data collection,” Shuren said.

It doesn’t appear Congress is keen on taking up the proposal anytime soon.

House Energy & Commerce Committee Ranking Member Greg Walden, R-Ore. has “asked for legislative text that would help us understand the proposal,” according to a Republican committee aide. And a Democratic aide told MedTech Dive lawmakers have “a number of concerns about this proposal.”

While ideas in the president’s budget are often called “dead on arrival” in Congress, Diana Zuckerman, president of the National Center for Health Research, said it is concerning FDA is pushing the idea.

She notes most commissioners do not have medical device experience and delegate responsibility to the CDRH director.

“This is exactly in contradiction to then-Commissioner Gottlieb’s letter. This is a radical proposal. It is radical in a way that really puts patients at risk,” Zuckerman said.


See the original article here.

FDA Reviews Breast Implant Safety as Women Raise Concerns

Diane Ashton, Fox News: April 11, 2019.

Thousands of women across the country who believe their breast implants are making them sick are calling on the Food and Drug Administration to take action. The women blame their implants for a number of auto immune illnesses, and a variety of symptoms such as joint and muscle pain, chronic fatigue and migraines. They’re demanding new warnings and restrictions on the devices.

The FDA maintains there is not enough evidence to link breast implants and connective tissue diseases like lupus and rheumatoid arthritis. However, it has acknowledged that women with breast implants may have an increased risk of developing a rare cancer called anaplastic large cell lymphoma (ALCL). Nearly 700 cases have been reported worldwide, and most involved textured implants. Canada and the Netherlands are suspending sales of textured implants, and France has banned them.

An FDA advisory committee held hearings on breast implant safety on March 25 and 26 in Silver Spring, Maryland. After the two-day hearing, the panel didn’t recommend any immediate restrictions on the implants. The FDA says it will reveal what actions it will take in the coming weeks.

Dr. Diana Zuckerman, president of a Washington DC-based non-profit called the National Center for Health Research, testified at the March 25th FDA hearing. She tells Fox News, “We don’t know how many women get sick from breast implants but we do know that some women are getting very sick. And the evidence is when the implants are removed, they can have almost miraculous recoveries. And so it’s time for the FDA to acknowledge that breast implants can make women sick with these autoimmune types of symptoms. And to warn them about it before they get breast implants, but also to warn them about it when they start to get sick.”

At the FDA hearing, researchers said it’s possible that silicone that leaks from implants can trigger or worsen immune system disorders in some patients. “One of the things that’s possible is that some women have a genetic predisposition to have a problem with breast implants,” Zuckerman says. “Maybe they have a family member with auto immune disease or maybe they themselves have had some auto immune symptoms. That’s what we found in our study, so we think that probably some women are more likely to get sick than others. “

Breast implant makers and the American Society of Plastic Surgeons say the implants are safe. But dozens of women who attended the FDA hearing, including Andrea Ottaiano of Morristown, New Jersey, are calling for a “black box” warning on the devices and a ban on textured implants. They also want a better patient consent process so women can be informed of the risks before getting breast implants.

“There’s not a lot of full disclosure that goes along with these devices and a lot of women that were getting them whether it was for augmentation or it’s a breast cancer reconstruction aren’t fully presented with the risk-benefit ratio, “ Ottaiano says. “And that… was just quite shocking to me, because in the field that I worked in for years, it was always so important to have transparency, and present if there were safety issues or risks.”

Ottaiano, a three-time cancer survivor, is getting her implants removed this spring. She says in the last several years, she has suffered from a painful complication called capsular contracture, along with joint pain, fatigue and other symptoms she believes are being caused by her breast implants. “My concern for my own health is I’ve had implants in for 11 years post a breast cancer bilateral mastectomy, and I’ve done the research and done the math that they are not lifelong devices. They do have a life expectancy and sometimes they need to come out. So I was lucky enough to find a doctor last year that actually listened and agreed to a course of action.”

In the United States, about 400,000 women get breast implants each year. Some 100,000 get them after cancer surgery. New York City plastic surgeon Dr. Constance Chen says she tries to educate her patients about the pros and cons of breast implants, and tell them about alternatives, such as breast reconstruction using natural tissue. Dr. Chen thinks more research needs to be done into breast implant related illnesses.  “It’s very difficult to prove causality when it comes to auto immune illnesses and implants,” Chen says. “So the evidence is sometimes hard to get which I think is part of the problem.”

She adds, “There are a lot of people who find implants just don’t agree with them, whether it’s they develop these auto immune symptoms, or it’s a foreign body that their body just doesn’t want inside of them. I’ve seen too many people who have developed these non-specific symptoms — like brain fog, fatigue, joint pains, food allergies, drug allergies, etcetera — to write them off.”


See the original article here.

France Bans Breast Implants Amid Cancer Suspicions

Johane van den Berg, Longevity: April 5, 2019.

As of Thursday, specific types of breast implants – namely those with a textured or polyurethane coating – are no longer allowed in France. The ban of these implants are due to concerns that they have the potential to cause a type of cancer called anaplastic large cell lymphoma (BIA-ALCL). In finalizing the ban, France has become the first country ever to do so. According to Eyewitness News, the National Agency for Medicines and Health Products (ANSM) called the ban a “precautionary measure” which was taken due to the “rare but serious danger” caused by the implants.

It is estimated that approximately 70 000 French women currently have the banned implants, but it is not recommended that they have “explant” surgery to have them removed. Out of an estimated 500 000 women who have undergone breast augmentation that includes different types of breast implants, 59 cases of ALCL have been reported. As of yet, three women have died from cancer. However, the ANSM said in a statement that they had not identified “any immediate risk to the health of women carrying the implants concerned.” As reported by Euronews, after the ANSM consulted with experts, they came to the conclusion that the more “textured and rough” the implants, the greater the risk of developing the disease.

In addition, earlier this year, the most popular breast implants from the pharmaceutical company, Allergan, was withdrawn from the market in Europe, while December 2018 saw ANSM in France ordering the company to cease manufacturing and selling its Microcell and Miocell implants. Both of these types of breast implants are textured. With this week’s ban in France, Allergan’s Biocell implants will also be removed. In addition to Allergan, five more implant manufacturers will be affected by this ban, including Arion, Sebbin, Nagor, Eurosilicone, and Polytech.

It is not breast cancer. When presenting with breast implants, this cancer of the immune system (Hodgkin’s lymphoma) is typically found inside a capsule of fibrous scar tissue instead of inside the surrounding breast tissue. Research indicates that they are found more frequently in textured breast implants than smooth implants. As of yet, the type of filling does not seem to have an influence on this. It develops when white blood cells, known as T-cells, become abnormal in nature. They are typically present in the lymph nodes but have been known to affect other areas of the body. Click here to find out the reports from Harvard Health on this cancer relating to breast implants.

In addition, the agency communicated on this issue as early as 2011. According to Binita Ashar, MD, general surgeon and the director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, the FDA was the first public agency to warn the public about the risks for women with breast implants to develop this disease. In a press announcement that was released in February this year, results from an updated analysis of BIA-ALCL indicate that in the US, 457 women have been affected by this cancer, with the first documented case reported in 1997. 9 related deaths have been recorded.

The guidelines of the National Comprehensive Cancer Center (NCCN) that covers the diagnosis and treatment of BIA-ALCL state that the majority of women with this disease present with “a large spontaneous perioprosthetic fluid collection occuring at least 1 year and on average 7-10 years following cosmetic or reconstructive implantation following cosmetic or reconstructive implantation with a textured surface implant.”

The same guidelines have indicated that early diagnosis and treatment of the disease is usually associated with “excellent prognosis”. Metastasis has, however, been reported. In addition, the importance of initial ultrasound evaluation of women presenting with signs and symptoms of BIA-ALCL has been emphasized, and the NCCN recommends fine-needle aspiration as the method of fluid sampling.

“We hope that this information prompts providers and patients to have important and informed conversations about breast implants and the risk of BIA-ALCL. “At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,”. Dr Ashar wrote.

When it comes to patients, the FDA recommends that each person take the responsibility to educate themselves before agreeing to surgery. “Before getting breast implants,” the agency said in a statement, “make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surface implants. Additional information is available on the FDA’s Breast Implants website.

After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedures for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women. It ranks above liposuction, nose reshaping, eyelid surgery and a tummy tuck. The problem, explains Dr. Diana Zuckerman, Ph.D., and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation.

Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.

Symptoms of this condition – which Dr. Zuckerman explains, is a pattern of health problems likely caused by an autoimmune reaction to the implant – include mental confusion, joint pain, hair loss, dry eyes, chronic fatigue, and persistent flu-like symptoms. “In some cases,” she says, “silicone gel is leaking into their bodies and causing the autoimmune reaction. When the gel leaks into organs such as the lungs and liver, it can’t be removed surgically.” Click on the link to find out more about this condition and why it is gaining recognition.


See the original article here.

Are Breast Implants Safe? FDA is Looking into Claims

Kris Pickel, CBS5 News: March 25, 2019.

Are breast implants safe?

Tens of thousands of women say breast implants made them sick.

The US Food and Drug Administration (FDA) is now looking into the claims that Arizona’s Family Kris Pickel has been investigating for years.

Women from all over the country went to FDA headquarters in Washington on Monday.

These women represent the growing number of women coming forward  who believe breast implants are the source of unexplained illnesses ranging from extreme fatigue, joint pain to memory issues and auto-immune disorders.

Breast Implant Illness is not currently recognized as a medical condition.

The FDA’s stance is that science doesn’t link implants to illness. An FDA panel is taking another look at the science.  They are also hearing from doctors, experts, industry representatives and  women who became ill after getting implants.

Dr. Diana Zuckerman with the National Center for Health Research says 6,000 women have asked for  help getting insurance companies to pay for their implants to be removed.  Dr Zuckerman says they’ve only been able to help 1,000 women get their implants removed and of those only 25% were able to get insurance coverage.  

However, the results after explanting are dramatic. Of the 1,000 women, 90% reported their health improved with 61% saying there were “much better”.  

See the original story and video here.

Device-Safety Experts to FDA: Make Data Public

Christina Jewett, NBC News: March 27, 2019.

Medical device safety researchers are calling on the Food and Drug Administration to release hundreds of thousands of hidden injury and malfunction reports related to about 100 medical devices.

A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices.

One such program began about 19 years ago and allowed companies to file alternative summary reports about injuries or malfunctions into a database not visible to doctors, medical researchers or the public.

While the FDA pledged quickly to review the safety of one such device — the surgical stapler — researchers say the agency needs to open the data on scores of other devices, which have included mechanical ventilators and pacemaker electrodes.

“The FDA absolutely should be making all of this information available,” said Diana Zuckerman, president of the National Center for Health Research, who has testified to Congress and the FDA about device safety.

During a recent interview, FDA Commissioner Scott Gottlieb said that he had no immediate plans to release the device-safety reports, but that the matter is under review. In an updated statement Tuesday, he added that “we are looking at ways to make ASR [alternative summary reporting] data received prior to 2017 more easily accessible.”

“I think that the imperative of the agency is to make as much of this information available to the public as possible,” Gottlieb said during the interview last week. “I think these databases by and large should be searchable to the public.”

An agency spokeswoman said the FDA revoked most of the “alternative summary reporting” exemptions in mid-2017 and asked device makers who kept their exemptions to file a public report summarizing what information they’d send in a spreadsheet directly to the agency. That new approach doesn’t affect the hidden reports dating to 2000.

Agency data show that more than 2 million alternative summary reports have been filed since the start of 2014.

In a February guidance statement for device makers, the FDA said summary reporting can streamline reporting for the industry and simplify the agency’s review process “while maintaining or enhancing the quality, utility, and clarity of MDRs [device reports] through a more holistic view of reportable event trends.”

Makers of about 100 devices filed reports that way over the years, and the FDA has not disclosed the reports’ content beyond responding to KHN’s questions about specific devices. Among the devices involved are implantable defibrillators and the staplers, which in 2016 were linked to under 100 public reports of harm, even as nearly 10,000 malfunction reports were filed discreetly within the FDA.

Asked for more detail on staplers and other devices with exemptions, the agency referred to the Freedom of Information Act process, which can take nearly two years.

That’s not soon enough for organizations like the ECRI Institute. Chief policy officer Ronni Solomon said the nonprofit does device-safety analyses for the government and evidence-based reports for hospitals and performs device-related accident investigations.

Having thorough data on device-related harm is key on all fronts, she said, noting that the organization is exploring ways to get access to more FDA data.

Dr. Alan Shapiro, an associate professor at the New York University School of Medicine who has used the agency’s public device-safety database, called MAUDE, in his research, said paring down patient-safety data and keeping it in-house is the wrong move in the current era of artificial intelligence and automation.

He noted that an important safety tenet in hospitals is: the more eyes on the patient the better. He said there’s a clear parallel to the work researchers do with agency data to identify device-safety lapses.

“The FDA isn’t so capable that they can afford to hide data,” he said.

Hani Elias, chief executive of Lumere, said his consulting company uses the open FDA device data to advise health systems across the nation on device safety for purchasing decisions. He co-founded the company after seeing hospitals make device-buying decisions based on the effectiveness of the sales force rather than on quality and safety.

“There’s a lot of benefit in opening up this data,” Elias said.

Among the benefits of greater transparency would be the peer pressure among device makers — stripped of reporting exemptions — to make their products safer.

“You don’t want to be the people known for the products known for hurting people,” said Alan Card, an assistant professor and patient-safety researcher at the University of California-San Diego School of Medicine.

In 2018, the FDA approved a new pathway for makers of 5,600 device types to file malfunction reports in summary format. That program relieves the device makers of seeking a special exemption. It requires one public report detailing a novel or unique type of malfunction. Information about subsequent, similar malfunctions can be sent straight to the FDA in a spreadsheet.

The agency has also quietly granted device makers other summary-reporting exemptions for injury information gleaned from litigation and from device-specific registries used for research. Device makers filing such reports also have to file a public report summarizing the data that is sent directly to the FDA and isn’t readily available to the public.

Agency records show that some cardiac device makers have filed hundreds of death reports under the registry exemption. The FDA confirmed that nearly 12,000 litigation summary reports related to injuries associated with pelvic mesh were filed in 2017 alone.

Prior to the KHN investigation, Zuckerman said she was aware the FDA granted reporting exemptions but the sheer number of reports “takes my breath away.”

In the interview, Gottlieb said he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.” Gottlieb has announced his resignation; his last day will be April 5.[…]


See original article here.

Women Need Better Information on Breast Implants, Panel Says

Laurie McGinley, Washington Post: March 26, 2019.

Members of a Food and Drug Administration advisory committee scrutinizing the safety of breast implants urged the agency on Tuesday to take steps to ensure that patients have a clearer understanding of the risks — which includes a rare cancer that is linked to several deaths around the world — posed by the devices.

The members, speaking at the conclusion of a two-day FDA hearing, signaled support for a standardized, easily understood consent form that would lay out the major risks of the devices and be reviewed by patients and their doctors before a woman underwent surgery.

They said the FDA could negotiate the format and content of the consent form with patients, plastic surgeons’ groups and manufacturers. Frank Lewis, chairman of the agency’s panel on general and plastic surgery devices, said the current documents written by manufacturers are too long — some are more than 70 pages — and unwieldy. “They were constructed to provide legal protection for the companies,” he said.

During the sometimes emotionally wrenching hearing on implants, several women testified that they had not been adequately warned of risks posed by implants and were harmed by the devices.

The FDA had asked the panel to hold the hearing and provide guidance on several complicated issues involving implants, which have stirred controversy for decades.

The panel members came up with other suggestions for the FDA. One said that the tissue removed when implants are taken out should be analyzed by pathologists to try to understand what caused any illness or complication. Another said it was important to try to establish an official definition for “breast implant illness” — the constellation of autoimmune problems that many women say are caused by implants — so that insurance would pay for treatment of the ailments. The FDA has said the weight of evidence does not support such “systemic” effects from implants.

But the panel did not appear to reach consensus on recommending that any implants be taken off the market, including certain textured ones that have been linked to cancer. Many patients and advocates called for such a ban, but several panel members said they opposed the step at this time.

At the end of the meeting, however, Texas plastic surgeon Pierre Chevray, a member of the panel, called for banning textured implants that have been barred in other countries.

The FDA has identified 457 cases and nine deaths in the United States associated with the cancer, called Breast Implant-Associated Anaplastic Large Cell Lymphoma. Six hundred cases and 17 deaths have been reported worldwide. Several countries have banned one type of textured devices.

Diana Zuckerman, a longtime advocate who is president of the National Center for Health Research, said the recommendations from the panel “were rather vague,” but she said the meeting was important because it allowed women to tell their stories to the FDA and the surgery panel. “We don’t know what comes next, but I’m hopeful,” she said after the meeting.

The panel also said that the FDA should change its recommendation that women with implants begin to get MRIs after three years to check for ruptures. Perhaps starting after six years would be more practical, considering the cost involved, members said.[…]

See the original story here.

Women Who Say They Were Sickened by Breast Implants Demand FDA Action: ‘I Was Not Warned.’

Laurie McGinley, Washington Post: March 25, 2019.

Women who say they were harmed by breast implants demanded the Food and Drug Administration take new steps to protect consumers, including providing more information about potential risks and banning devices linked to the most serious complications, including cancer.

Telling searing stories about broken health, disrupted families and lost careers, the women pressed an FDA advisory panel to recommend more long-term research, bans or restrictions on certain products and a beefed-up informed consent process so that women have a clear understanding of the risks and benefits of the devices before they opt for surgery.

“I was not warned” about the risks of implants, Jamee Cook, an advocate and former ER paramedic, told the FDA’s expert committee. Cook, who lives near Dallas, said that after getting implants in 1998, she suffered for years from swollen lymph nodes, chronic fatigue, migraines and a low-grade fever. She said she eventually had the devices removed, after which many, but not all, of her symptoms eased.

The FDA said recently it is taking a closer look at implants, which have sparked anger and contention for decades. The agency asked its General and Plastic Surgery Devices Advisory Committee for recommendations on a raft of issues, and Cook’s testimony was part of a two-day hearing, which continues Tuesday, on the key issues.

Several plastic surgeons pleaded with the panel to proceed carefully, saying that implants generally are safe and an important option for women who want breast augmentation or reconstruction after breast cancer surgery. They said that women’s choices should not be curtailed. About 400,000 women a year get implants, 75 percent for cosmetic reasons and the rest for reconstruction after breast-cancer surgery.

Many of the dozens of patients who attended the meeting at FDA’s headquarters in Silver Spring, Md., wore ribbons to graphically state their concern about two types of illnesses they say are linked to implants. Black and white ribbons symbolized what’s now called “breast implant illness,” a constellation of autoimmune problems that includes joint and muscle pain and allergies and fatigue. Pink and green ribbons signified an uncommon lymphoma that health authorities around the world, including the FDA, link to some implants.

Anastasia Allmendinger, a 53-year-old resident of Newport News, Va., said that she got implants in 2010 and years later was diagnosed with the cancer, called anaplastic large cell lymphoma, or ALCL. She underwent surgery to remove the implants, chemotherapy and a stem-cell transplant, and is now doing well, but said that manufacturers should be held accountable for the illnesses and women should be better informed. Experts say that many patients can be successfully treated only with surgery.

Many of the advocates who spoke on Monday called for a ban on textured implants — the kind most strongly linked to the cancer. There is some evidence the problem could be caused by bacterial infections involving the implants, researchers said.

The FDA has identified 457 cases of the lymphoma and nine deaths in the United States. Six hundred cases and 17 deaths have been reported worldwide.

On the other main illness of concern — the one linked to autoimmune and connective-tissue disease — the FDA and the patient community have long been at odds.

Thousands of women have complained about autoimmune and connective tissue problems on social media but the FDA has repeatedly said that the “weight of evidence” does not show implants cause “systemic” illness.

That opinion was challenged last September, when researchers at MD Anderson Cancer Center found that silicone implants were linked to higher rates of autoimmune disorders such as scleroderma and rheumatoid arthritis than found in the general population. A leading author, Mark Clemens, said the study didn’t prove cause and effect but signaled a reason for concern.

The FDA immediately expressed skepticism, saying the study was flawed. But Binita Ashar, the agency’s director of surgical devices at the FDA’s Center for Devices and Radiological Health, also said the agency is stepping up its long-term surveillance of implants and using patient registries to track complications from the devices.

That view was repeated in the agency’s announcement about the meeting that began Monday. The FDA said that “there is not sufficient evidence to show an association between breast implants and rheumatologic or connective tissue disease diagnoses.” But it added, “there are numerous breast implant patients convening on social media to discuss a wide variety of symptoms that they are experiencing – symptoms which may or may not meet the diagnostic criteria to be categorized as a disease.”

Diana Zuckerman, president of the National Center for Health Research, said in an interview she doesn’t understand “why the FDA seems so close-minded” about the scientific evidence that at least some women have developed autoimmune diseases as a result of their breast implants. “We have always said we don’t know what the percentage is — just that for women who are sick, getting them out makes them better,” she said.

Zuckerman presented data on Monday from a study that her group conducted involving more than 400 women who had their implants removed because they were having health problems. In the vast majority of cases, she said, the women’s health improved. The study has not been published yet. […]

See the original story here.

US Experts: Too Soon to Pull Breast Implants Tied to Cancer

Matthew Perrone, Associated Press: March 25, 2019.

Government medical advisers said Monday it’s too soon to ban a type of breast implant that has recently been linked to a rare form of cancer, saying more information is needed to understand the problem.

The Food and Drug Administration panel didn’t recommend any immediate restrictions on breast implants after a day reviewing the latest research on the risks of the devices, which have been subject to safety concerns for decades.

The FDA has been grappling with how to manage emerging science that shows the implants can trigger a rare form of lymphoma that grows in the scar tissue surrounding the breasts. The agency identified about 450 cases of the cancer worldwide, including 12 deaths. Almost all of the cases involve a type of textured implant that is designed to stop implants from slipping and to minimize scar tissue.

But the majority of the 19 panelists — including plastic surgeons and cancer experts — said it was too soon to remove the products from the market.

“Do we want to get into the situation where we pull one sweetener and the replacement is even worse?” said Karla Ballman, a biostatistician at New York’s Weill Cornell School of Medicine. “I think a knee jerk reaction of just pulling something without knowing what the replacement will be might get us into more trouble.”

Estimates of the frequency of the disease range from 1 in 3,000 women to 1 in 30,000. It grows slowly and can usually be successfully treated by removing the implants. The FDA said it has also received reports of the disease in smooth implants — which account for most of the U.S. market.

Another panelist said a ban on textured implants would be an “extraordinary overreaction.”

But that opinion wasn’t unanimous. The panel’s consumer representative stressed the risk to women who get implants for reconstructive purposes after breast cancer surgery and could face a second cancer.

“I think that’s so much of a risk that they need to be taken off the market,” said Roberta Brummert. Her comments set off cheers from dozens of women who attended the hearing.

In the U.S., roughly 400,000 women get breast implants each year; 100,000 women get them after cancer surgery.

On Tuesday, the same FDA panel will make recommendations on studying and defining the risks of long-term chronic conditions with breast implants. Thousands of women have blamed their implants for a host of other chronic ailments, including rheumatoid arthritis, chronic fatigue and muscle pain.

Patients and advocates have used the recent scrutiny to call for new warnings and restrictions on implants.

“Don’t ignore us. We are real,” said Holly Davis, of Charleston, South Carolina.

Davis, 60, said she experienced chronic pain, hair loss, rashes and memory loss after receiving silicone gel-filled implants following a double mastectomy in 2002. Davis said she learned her implants had ruptured when they were removed in 2017; her symptoms have since resolved.

She and other patients want the FDA to require manufacturers to give standardized risk disclosure information to all women considering implants.

“We need to know what we’re signing up for — it can’t be a surprise down the road,” Davis said.

In the U.S., most women choose silicone implants, which are considered more natural looking than saline implants. Both types have a silicone outer shell.

The panelists also heard from researchers who theorize, based in part on animal studies, that silicone that leaks from implants can trigger or exacerbate immune system disorders in certain patients.

In 1992, the FDA temporarily pulled silicone gel implants from the market because of fears they might cause breast cancer, lupus and other disorders. But when studies seemed to rule out most of the disease concern, regulators returned them to the market in 2006.

But critics of that research noted its shortcomings at Monday’s meeting.

“The studies at that time were not very good and did not have the statistical power to determine rare diseases,” said Diana Zuckerman, president of the nonprofit, National Center for Health Research, which published an analysis of more than 20 breast implant studies last year. The group concluded that virtually all were too small or too short or didn’t focus on patients who had their implants long enough to develop problems.

The FDA says on its website there is no “apparent association” between breast implants and chronic, debilitating diseases, such as connective tissue disease.

However, earlier this month, the FDA appeared to signal a shift in its thinking. The agency said it would begin studying whether certain materials used in breast implants, metal hips and other devices can trigger health problems in patients.

“We believe the current evidence, although limited, suggests some individuals may be predisposed to develop an immune-inflammatory reaction when exposed to select materials,” the agency said in a statement.


See the original article here.

FDA Takes Hard Look at Breast Implant Safety Amid Fresh Cancer Fears

Maria Rachel, MedTech Dive: March 21, 2019.

When FDA Commissioner Scott Gottlieb and device center chief Jeff Shuren teased next week’s advisory panel tackling breast implant safety, it was tucked into a broader communication on postmarket safety efforts.

But in the four months since, FDA and a domino line of regulators and scientists have flagged upticks in known cases of breast implant associated anaplastic large cell lymphoma. The form of non-Hodgkin lymphoma has been traced to at least nine U.S. deaths. And University of Southern California plastic surgeons published the first known case of similar disease in a recipient of buttocks implants.

Last week, FDA announced an initiative to scrutinize device materials’ biocompatibility, including in the case of silicone breast implants, pointing to potential harmful autoimmune reactions to the devices.

With days before the two-day meeting, the FDA chided Sientra and Johnson & Johnson-owned Mentor for not adequately meeting post-approval study standards, citing low recruitment and poor data and follow-up rates. The only other market competitors are Allergan, whose textured breast implants lost CE marking last December, and privately held Ideal Implant, the newest entrant to the U.S. market.

The FDA is expected to release background materials and specific panel questions prior to the March 25-26 meeting, but none were published as of late Thursday morning ahead of what appears to be at least the eighth advisory committee meeting on breast implants since 1991, according to an agency timeline.

The agenda Monday is set to focus on BIA-ALCL, and Tuesday slated for discussion of everything else: use of MRI screening for silent rupture of silicone gel filled breast implants, surgical mesh in procedures like breast reconstruction and mastopexy, registries for postmarket surveillance, and real-world data and patient perspectives in regulatory decision making.

Here are some facts to know before the meeting.

Early Approvals and Controversy

The International Society of Aesthetic Plastic Surgery reported there were more than 281,000 breast augmentations with silicone implants in the U.S. in 2017, and more than 44,000 implant removals.

Breast implants are sold in a variety of shapes, sizes and materials, with those with textured surface in particular often cited as tied to BIA-ALCL. Textured silicone gel-filled implants may be chosen over smooth ones because the surface is supposed to help them stay in place and pose lower risk for capsular contracture, or formation of scar tissue around an implant, which can lead to other adverse outcomes like leakage or rupture.

Breast implants were made a Class III device in 1988, but it wasn’t until 1991 that FDA issued a final rule calling for PMA applications for silicone gel-filled devices. In 1992, after concluding that manufacturers did not prove adequate safety and effectiveness data for their products, FDA opted to introduce a voluntary moratorium on breast implants. During that period, access to gel-filled implants, which were defined as investigational devices, was given to providers whose patients were undergoing breast reconstruction or replacement of existing implants, known as revision. Those patients were meant to be followed through adjunct clinical studies.

Over the next decade, Allergan and Mentor had adjunct and investigational device exemption studies approved by FDA. The agency also cleared the first saline-filled breast implants, which are thought to pose a lesser health risk upon leakage or rupture than their silicone counterparts, from the two companies in 2000.

The moratorium was officially lifted in 2006 with FDA approving silicone gel-filled implants from Allergan and Mentor indicated for augmentation, reconstruction and revision, with the understanding that both manufacturers must conduct post-approval studies.

Lymphoma Concerns Flagged

Prior to the next generation of product approvals that came from Sientra in 2012, Allergan and Mentor in 2013, and Ideal Implant in 2014, FDA became the first national public health organization to flag BIA-ALCL in 2011. At the time, it was referred to only as ALCL in women with breast implants. The American Society of Plastic Surgeons describes the disease as “rare” and “highly treatable.”

In September of last year, the MD Anderson Cancer Center published a data analysis from more than 100,000 U.S. patients with breast implants. Researchers found that recipients of silicone implants had higher than normal rates of conditions like Sjogren syndrome, scleroderma, rheumatoid arthritis and melanoma, and that at seven years, reoperation rate was 11.7% for cases of primary augmentation and 25% for primary or revision reconstruction. Mark Clemens, a senior investigator on the study, is among the featured presenters Monday.

FDA said the data had “significant shortcomings” and defended its record, citing its assistance in implementing the PROFILE registry, which has tracked BIA-ALCL since 2012, and the National Breast Implant Registry (NBIR), launched six months ago to follow a broader range of patient outcomes, with FDA noting symptom patterns like chronic fatigue, cognitive issues and muscle pain. A February update from FDA indicated the agency had received 660 medical device reports related to BIA-ALCL.

“While the FDA does not have evidence suggesting breast implants are associated with these conditions, information from NBIR may help us identify risk factors for complications, such as a patient’s own medical history, the specific type of operation, the type of implant used, and concomitant use of other medical devices,” it said in a November release.

Business Impact

It remains to be seen how an increase in data and heightened involvement from FDA and other regulators could impact manufacturers’ sales. As of 2017, worldwide silicone-based breast augmentations were up about 1% to nearly 1.47 million, according to ISAPS. Breast implant removal procedures were up 8%. While the swift exit from the European market tanked Allergan’s international breast implant sales 74% year over year, that business is small compared to some of the pharma’s higher-performing products like Botox or its Restasis eye drops.

Meanwhile, some companies are looking to seize the moment. Nasdaq-listed Costa Rican company Establishment Labs launched an IPO and gained FDA approval for its investigational device exemption trial in 2018.

efferies analysts said in a note to investors Wednesday the company is experiencing a “perfect storm,” in which FDA’s upcoming actions could negatively impact current market players, but consumer interest in plastic surgery doesn’t seem to actually be declining.

“The breast implant market is ripe for the taking,” the analysts wrote.

What the Watchdogs Say

The panel could follow in the footsteps of those who weighed in on Essure, who advocated for better informed consent for patients; FDA ultimately issued the product a “black box warning,” which is reserved for calling out serious or life-threatening risks on a package’s label.

Madris Tomes, a former program manager at FDA who now analyzes adverse event data through her company Device Events, said the black box warning was not effective for patients in the case of Essure, and probably wouldn’t make a significant difference for potential breast implant recipients either.

“The patient won’t see a black box warning because they don’t see the box for the [product] that’s going to be implanted in them,” she said.

National Center for Health Research President Diana Zuckerman agreed that a black box is possible, and while FDA rarely recalls devices and already oversaw a long moratorium in this device category, she said a partial market removal of textured implants in particular wouldn’t be unheard of.

Tomes and Zuckerman think the benefit of registries is overstated, too.

“[The data] are not available to the typical doctor, and that’s not going to help with identification of autoimmune issues,” Tomes said. “Plastic surgeons are the ones using those registries, not rheumatologists and immunologists and family doctors.”

Zuckerman echoed those concerns.

“The data are not publicly available unless the American Society of Plastic Surgeons chooses to make it available,” Zuckerman said. “That’s a problem because of potential conflicts of interest that might result in not publishing results that are detrimental to ASPS.”


See the original story here.