Category Archives: We Are Quoted

FDA Ending Controversial ‘Alternative Summary Reporting’ Program

Thomas Dworetzky, DOTMed News: May 8, 2019.


Following the groundbreaking Kaiser Health News report exposing the scope of the little-known FDA “alternative summary reporting” program that let medical device makers “conceal millions of reports of harm and malfunctions from the general public,” the agency has now stated that it will be shutting the program down, according to KHN.

FDA cited the decision in a statement about its “new efforts to protect women’s health and help to ensure the safety of breast implants,” especially textured implants, which have been linked to a type of cancer and which the agency now plans to leave on the market as it “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,” Amy Abernethy, M.D., Ph.D., FDA’s principal deputy commissioner, and Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement. But the announcement also addressed the way in which adverse breast implant events were reported with “alternative summary reporting,” stating that “the FDA has ended all summary reporting of breast implant medical device reports.”

The statement then addressed the controversial alternative reporting issue for devices beyond the implants, as well.

“This is part of a larger effort to end the alternative summary reporting program for all medical devices, which we intend to complete in the coming weeks,” the agency stated, continuing, “this program was established in 1997 to more efficiently review adverse events for well-established risks, but was not allowed for patient deaths and unusual, unique or uncommon adverse events, which, in the case of breast implants, included BIA-ALCL. Alternative summary reports were not previously available in our public database for medical device reports, Manufacturer and User Facility Device Experience (MAUDE) [the FDA public-facing database of device safety reports].

The Kaiser report exposed that the 20-year-old program had 1.1 million reportskept from both public and professional review since 2016.

Former FDA official Dr. S. Lori Brown told KHN that this ending was a “victory for patients and consumers.”

“The No. 1 job of the FDA — it shouldn’t be ‘buyer beware’ — is to have the information available to people so they can have information about the devices they are going to put in their body,” Brown told the investigative news group.

In March, the revelations in the KHN report prompted concern for healthcare professionals.

“The FDA absolutely should be making all of this information available,” Diana Zuckerman, president of the National Center for Health Research, told the news agency. 

The numbers of these “alternative summary reporting” (ASR) exemptions, Zuckerman added “takes my breath away,” KHN reported at the time. 

Former FDA chief Dr. Scott Gottlieb confessed to the news agency at the time that he “wasn’t aware of the full scope of the reports that weren’t going into MAUDE.”[…]

 

See the original story here.

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.

FDA Orders Makers of Women’s Surgical Mesh to Stop Selling the Products

Thomas Burton and Stephen Nakrosis, Wall Street Journal: April 16, 2019.


The U.S. Food and Drug Administration ordered the two makers of surgical mesh for women’s pelvic repair to take their products off the market, responding to years of complaints about pain, bleeding and scarring from the devices.

The federal agency, following a safety hearing on the topic in February, said that Boston Scientific Corp. and Coloplast Corp. hadn’t demonstrated reasonable evidence that the mesh products worked better than surgery without the products.

Transvaginal mesh is used to treat a condition called pelvic organ prolapse, in which organs like the bladder, uterus and others sag into the vaginal area. It is estimated that about one in eight women has surgery in her lifetime to treat the condition.

The condition can be treated with conventional surgery that uses a woman’s own tissue. But some surgeons have maintained that the synthetic mesh product can lead to a more permanent repair. Mesh products also are used in hernia repair and urinary incontinence treatment, but these uses carry a lesser risk in the view of surgeons and they remain on the market.[…]

 

See original story here.

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.