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In addition, earlier this year, the most popular breast implants from the pharmaceutical company, Allergan, was withdrawn from the market in Europe, while December 2018 saw ANSM in France ordering the company to cease manufacturing and selling its Microcell and Miocell implants.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.

See the original article here.

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.

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.

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.

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.

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.

Maria Rachal, 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.

[…]

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.

This is a greatly shortened version of the article.  To read the entire article in MedTech Dive, see here.

Mia de Graff, The Daily Mail: March 20, 2019.

Days before a hearing on breast implant safety, US regulators have sent warning letters to two of the top implant manufacturers involved.

In the letters, the US Food and Drug Administration reprimanded Mentor and Sientra for historically failing to complete the safety studies required for medical devices to stay on the market.

If the firms do not have completed data within 15 days, the FDA warned, their blockbuster silicone implants could be pulled from the market.

The warning is a gesture to patients that the FDA intends to be firm with breast implant manufacturers, whose products have stayed on the market for years without adequate safety data, despite ranking in the highest-risk bracket for medical devices.

It comes amid global concerns over the safety of silicone breast implants, which have been officially linked to cancer of the immune system, and are alleged to cause autoimmune disorders.

Lauren Dunn, NBC News: March 19, 2019.

Less than a week before a major hearing on breast implant safety, the FDA issued two warning letters to implant manufacturers, citing their failure to do proper safety studies.

The letters sent to Mentor and Sientra warned that certain implants could be pulled off the market if the companies didn’t fulfill the agency’s requirements, which ask that manufacturers continue safety studies even after the devices are approved.

According to the letters, Mentor failed to enroll enough people in these studies. Sientra had poor follow-up rates.

“The FDA has the authority to say you either have to study it or take off the market and the company has the incentive to do one or the other,” Diana Zuckerman, president of the National Center for Health Research, told NBC News.

Zuckerman also called the letters “surprising but encouraging,” and questioned whether the FDA would take action if the companies failed to comply with the warning letters.

“You can’t assume that just because they sent the warning letter, it’s anything more than the FDA flexing their muscles,” Zuckerman said. “If the companies don’t get scared enough to comply, the big question is whether the FDA will follow through.”

In a statement to NBC News, Mentor, said it had made “multiple attempts” to discuss study requirements for its MemoryShape breast implants with the FDA.

Denise Grady and Roni Caryn Rabin, New York Times: March 19, 2019.