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More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database

Sydney Lupkin and Christina Jewett, KHN; May 30, 2019


UNITED STATES – NOVEMBER 9 – The outside of the Food and Drug Administration headquarters is seen in White Oak, Md., on Monday, November 9, 2015. The FDA is a federal agency of the United States Department of Health and Human Services and has been in commission since 1906. (Photo By Al Drago/CQ Roll Call)

The Food and Drug Administration has acknowledged that more than 56,000 never-before-disclosed surgical stapler malfunctions were quietly reported to the agency from 2011 through 2018.

The newly acknowledged reports were detailed in an executive summary for FDA advisers. The agency convened a meeting of experts this week to help it determine whether surgical staplers should be moved out of its lowest-risk category — reserved for simple devices like tongue depressors and bandages — to a higher grade that may require testing and additional oversight. Surgical staplers are used to cut and seal vessels and tissues inside the body.

When the FDA initially announced the meeting in March, it acknowledged in a letter to doctorsthat “many more device malfunction reports” were reported to the agency than it had publicly disclosed. The FDA executive summary published this week shows that the total reports more than doubled when the agency took nonpublic reports into account, totaling nearly 110,000 malfunctions or injuries from 2011 through 2018.

“It shocks the conscience,” said Chad Tuschman, a lawyer representing Mark Levering, 62, of Toledo, Ohio, who suffered a serious brain injury after a stapler malfunction caused massive bleeding in 2018. The surgeon, hospital and device maker Covidien, a division of Medtronic, have all denied allegations of wrongdoing in an ongoing legal case.

Surgical staplers have a unique ability to harm patients if they malfunction. Often used in minimally invasive surgeries, they are meant to both cut tissue and vessels and then quickly seal them. Patients have been gravely harmed when staplers have failed to fire or seal tissue, suffering from massive bleeding or infections if stomachs or intestines aren’t sealed properly.

The nonpublic reports were sent to the FDA as “alternative summary” reports, the topic of a recent Kaiser Health News investigation that focused on the agency accepting millions of hidden reports related to medical devices — including for surgical staplers.

The agency had previously acknowledged that in 2016, even as it posted fewer than 100 stapler-related injuries in a public database called MAUDE, it accepted nearly 10,000 reports into its little-known internal alternative summary reporting database. (The data in the FDA’s executive summary contains reports for staplers and staples, which experts have said were just different names for the same problem.)

Tuschman said he was stunned that there were more hidden reports than public ones in the executive summary. “The first question should be ‘Why?’ Why would they have the right to submit to a hidden database?”

Leading surgical stapler makers include divisions of Medtronic and Johnson & Johnson. Medtronic has said the FDA granted it exemptions for stapler-related malfunctions; Johnson & Johnson said it has not. (Ethicon is the name of its subsidiary medical devices company.)

On Thursday, the advisory panel recommended switching surgical staplers to a higher-risk classification with additional safety requirements, according to meeting attendee Jack Mitchell, director of health policy for the nonprofit National Center for Health Research. FDA spokeswoman Stephanie Caccomo declined to confirm this, citing a media office policy against telling reporters what happens at advisory committee meetings, which are open to the public.

“Every surgeon that I have ever worked with has had stapler failures,” said Dr. Doug Kwazneski, a Michigan surgeon who authored a survey in 2013 about “unacknowledged” stapler problems after searching the FDA’s public database of device incidents and coming up empty-handed.

“Going into something without data is dangerous,” Kwazneski said. “If the information exists, we should have access to it.”

More than 400 deaths have been reported since 2011 in the FDA’s public MAUDE database; fatalities can’t be reported to the alternative summary reporting database. Deaths were associated with Ethicon and Covidien products.

In recent communications about stapler safety to doctors, the FDA has advised against using the staplers on large blood vessels.

Kwazneski said surgical staplers are a time-saving tool, which lessens the risk of anesthesia complications during surgery, for example. But it’s important for physicians to remember they can fail.

Diana Zuckerman, president of the National Center for Health Research, said that alternative summary reports are “a well-kept secret” and that any reports related to their existence were “done in a way that was not understood as a repository for hundreds of thousands of serious adverse event reports.” […]

See the original story here.

How the FDA Handles Recalls of Life-Saving Implants Could Put People at Risk, Patients Say

Nicole Carr, WSBTV; May 20, 2019



Jonesboro resident Geraldine Robinson is one of millions of Americans who use an implanted medical device to improve, and possibly extend her life.

In 2013 she was implanted with a defibrillator to help with her congestive heart failure. She went to the doctor for checkups every six months. Robinson thought her device would keep her healthy for years. But last month the hospital called to tell her that device’s battery was failing. Robinson rushed to the emergency room.

“I was scared they wasn’t going to get to me in time,” Geraldine said.

The next day doctors replaced her device. The reason for the surgery noted on her patient information card was, recall.

Channel 2’s Nicole Carr searched the FDA recall database and found Robinson’s device had been recalled two years earlier. The manufacturer’s suggested course of action was to monitor the device.

While Robinson said she had no idea her device was recalled, her hospital said she was mailed a letter to notify her. Robinson said she never got that letter.

Diana Zuckerman, president of The National Center for Health Research, said she wasn’t surprised that Robinson’s recalled device remained implanted for years.

“This is the doctor having to say to the patient, ‘This implant in your body has been recalled but we don’t think you should have it removed unless you’re having obvious problems with it,” Zuckerman said.

Zuckerman was also said Robinson is most likely not alone in her confusion, and often patients don’t learn their device is recalled.

“Perhaps the patient has moved and the doctor or even the hospital doesn’t know where that patient is anymore,” Zuckerman said.

Linda Radach, an implant recipient herself, said she believes the recall process needs an overhaul.

“The FDA is very, very slow to use their authority to issue a recall instead requiring warning letters and requiring post market surveillance studies. Most of which are never completed,” Radach said.

According the FDA website they hardly every issue a recall, instead trusting manufacturers to self-report. An FDA spokeswoman said recalls are not the only way they get dangerous products off the market.

There are several patient resources available for medical device recipients, including questions to ask your doctor about the approval process.

Radach said a 2006 metal on metal hip replacement failed leaving dangerous cobalt chromium debris in her system.

“I’ve now had six total hip replacements,” Radach said. She said her issues were never reported to the FDA by her doctors and her device was never recalled. She did her own research and found her device had been approved for market three years after it was put in her body. “That alarmed me enough to realize this was much, much bigger than just me.”

Radach told Channel 2 Action News many of the parts that made up her implant were cleared through the 510k process which rarely requires clinical trials on human patients. The process has been in place since 1976.

Zuckerman said the 501K process it’s not enough.

“All those companies have to do is prove that their new device is substantially equivalent to a device that’s already on the market,” Zuckerman said.

In 2011 Zuckerman co-authored a report that found from 2005 until 2009, 113 recalls were class one. Only 21 of those recalls went through clinical trials. She said things haven’t improved.

“Instead of saying ‘let’s be more stringent and require clinical trials for more implants,’ they’re doing exactly the opposite,” Zuckerman said. […]

See the original story here.

Breast Reconstruction Options After Mastectomy


Many breast surgeons and breast cancer patients believe that breast reconstruction is an important step in recovering physically and mentally from a mastectomy.  Research shows that women who undergo flap procedures (described below) have a better quality of life after reconstruction than women undergoing reconstruction with breast implants.1

However, not all women are able to undergo those procedures.  Unfortunately, many patients are not given complete information about the different options for breast reconstruction, including the risks and benefits of each.  In fact, a recent study showed that only 43% of mastectomy patients received the information and counseling necessary to make an informed decision regarding their reconstruction choice.2

The Women’s Health and Cancer Rights Act of 1998 is a law that requires that private insurance companies pay for breast reconstruction if they pay for mastectomies.  This includes reconstruction on the removed breast, modification of the other breast to create a symmetric appearance, and treatment of any complications that result from a mastectomy or reconstruction.  The forms of reconstruction covered may vary by state and insurance provider, so it is important that you call your insurance provider to see which options will be covered in your particular case.3

This article does not provide medical advice, but we provide information based on scientific research and from speaking to many experts in the field.  We recommend discussing your treatment options with a physician whom you trust.  As a patient, you have the right to seek more than one medical opinion.

Which Type of Breast Reconstruction is Best?

The decision of which reconstruction option to choose, if any, is a personal one.  To make an informed choice, however, patients need to meet with breast surgeons who are skilled at the different options.  Since most breast surgeons only know how to do reconstruction with breast implants, they don’t usually provide good information to their patients about the benefits of other options.

There are several studies which look at the long-term outcomes for each of the reconstruction options, and these can help patients to make a decision.

For example, a study published in 2018 analyzed over 2000 reconstruction patients and found that patients who undergo autologous breast reconstruction (“flap” procedures) are generally more satisfied in the long-term than women who choose reconstruction with breast implants.  After two years, patients who chose to get flap procedures reported having a better quality of life than patients who got breast implants.  Some of the areas in which the flap patients reported greater satisfaction include their psychosocial, physical, and sexual well-being.4

The researchers also found differences in surgery-related complications within the first 2 years after surgery.  Flap procedures have significantly higher rates of short-term surgery-related complications that occur immediately following surgery.  In contrast, breast implants have more surgery-related complications that occur weeks or months after the surgery is completed. 5 In addition, women are likely to need multiple surgeries to replace implants over their lifetime.6

A description of the options for reconstruction is below.

Reconstruction with Breast Implants

Breast implants are the most common form of breast reconstruction after mastectomy.  7 This is probably because breast implants are the easiest form of reconstruction and most plastic surgeons are not skilled enough to perform the other types of breast reconstruction discussed below.  There are silicone gel breast implants and saline breast implants on the market, and both options have a high complication rate for reconstruction patients.  You will probably be told that breast implants are not lifetime devices, but that’s an understatement.  Studies by researchers and by implant manufacturers have shown that after three years, most reconstruction patients will have at least one serious complication.8,9

Below are some of the most common complications of breast implants.

In addition, women who have breast implants, either for mastectomy or healthy breasts, are more likely to develop a type of lymphoma (cancer of the immune system) called ALCL.17

You can read more about risks and complications related to breast implants here and more about the different types of breast implants here.  Despite the risks, some women get implants because they are not good candidates for other types of breast reconstruction.  Women who are very thin or very physically active, have poor veins, or who may become pregnant in the near future may not be good candidates for other reconstruction options.

Reconstruction with Autologous Tissue Transfer (Flap Procedures)

Autologous tissue transfer (also known as a flap or flap procedure) refers to any procedure in which the body’s own tissue is used to reconstruct breasts.  Surgeons take fat and other tissue from another part of a woman’s body and move it to create breasts.  Sometimes, implants are used along with the tissue transfer to create larger breasts.  When implants are used with flap procedures, the risk for complications is higher than for either procedure alone.  For that reason, it makes sense to choose either flap reconstruction or implants but not both.

There are various types of autologous tissue transfer as described below.

Flap Reconstruction with Muscle and Fat

In this procedure, surgeons take muscle and fat from other areas of the body and move it to the breast area.  The most common form of this procedure is the TRAM flap, which uses muscle and fat from the abdomen.  While using stomach muscle is typical, surgeons can also take muscle from the inner thigh or buttocks.  Reconstruction methods using fat and muscle create a more natural looking reconstruction than those using only fat due to their added firmness.   Also, the larger amount of tissue used during muscle and fat reconstructions enables the surgeon to create larger breasts than those with fat only.  A drawback to this type of surgery is its complexity.  Veins and arteries must be reattached to the muscle and fat, so this surgery requires an experienced vascular surgeon.  Even with a good surgeon, this surgery isn’t 100% successful.  However, if it is successful, these reconstructed breasts can last a lifetime.   But, if muscle is removed from the abdomen, the women will not have as much strength there as they did before.18

Flap Reconstruction with Fat Only

Some reconstructions are performed using only fat.  The most common form of this is the DIEP flap, which takes skin, vessels, and fat from the abdomen but spares the muscles.  Surgeons can take tissue from most areas of the body that have a large fat supply.19 Reconstruction with only fat takes more time than other procedures because the tissue has to be harvested and removed from the body before the reconstruction can take place.20 To be a good candidate for this procedure, women need more body fat to create the breast.  This means that women with low body fat or poor vascularity may not be good candidates for this surgery.  The difficulty of this form of reconstruction are similar to those of reconstructions done with muscle and fat.  However, since no muscle is used, patients should not expect to permanently lose strength in any part of their body.21

Reconstruction with the Latissimus Dorsi

This surgery, commonly known as Lat flap, uses the latissimus dorsi muscle to reconstruct breasts.  The latissimus dorsi is a muscle of the upper back that extends around the side of the body. This procedure is more likely to fail than some other flap procedures, but less likely to have surgery-related complications or need reoperations within the first two years.22

Lat flap can be performed on women who do not have enough body fat for other forms of autologous reconstruction, and is frequently used with breast implants.  Some surgeons prefer it because the only visible scar will be from the mastectomy, and because the muscle can remain attached to its original blood source, which lowers the chance of the tissue dying after transfer.  However, since the latissimus dorsi is a large and important back muscle, the procedure can lead to serious difficulties moving, lifting, or performing strenuous exercise.  Patients who choose this option can also expect to get fatigued more easily.23

It’s Your Choice

As you can see from the research above, flap procedures are a very good choice for women who want a lifetime solution that avoids the complications typical of breast implants, and the possible risk of developing lymphoma.  However, fewer doctors perform flap procedures.  They are also longer and more complicated surgeries than reconstruction using breast implants.  For this reason, it is extremely important that women choosing a flap procedure go to a surgeon who is very experienced in autologous reconstruction.

When making a reconstruction decision, it is important for each woman to weigh the risks and benefits of each procedure with a doctor that is capable of these different options, so that she can make a decision that is right for her.

We hope this information is helpful. For more information, check out http://www.breastimplantinfo.org or feel free to write to us at info@center4research.org / info@stopcancerfund.org

The comments and statements of the National Research Center for Women & Families are believed and intended to be accurate, and where applicable, based on scientific literature. NRC’s statements do not constitute medical diagnoses, medical advice, plans of treatment, or legal opinion, and we are not responsible for the use or application of this information. All medical information should be reviewed with your health care practitioner.

We hope that the information we’ve provided is helpful. In order to maintain this free service to all women and their families, we invite your tax-deductible contributions to NRC (see http://www.center4research.org/contribute/ )

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.

Is the 21st Century Cures Act a Solution or a Problem?

Robert Kaplan, The Regulatory Review: May 7, 2019.


In December, 2016—a time when the U.S. Congress could barely agree on anything—the U.S. House of Representatives and the U.S. Senate came together to pass the 21st Century Cures Act. Championed by Representative Fred Upton (R-Mich.) and Representative Diana DeGette (D-Colo.), the Act uses 312 pages to outline a plan to accelerate the licensing and delivery of medical cures. It includes many attractive features. But, as I will show here, it also contains provisions that could increase risks to patients.

The Act was attractive because it provides about $6.3 billion in funding, mostly for the National Institutes of Health (NIH), the major supplier of research funding for American universities and research institutions. Although the NIH faces very little political opposition, the agency had been deprived of adequate funding for at least a decade.

Beyond support for the NIH, the Act was appealing because it provides funding for mental health care. It endorses parity in payment in most private and some federal health insurance plans for physical health and mental health services and strengthened suicide prevention programs. It also provides much-needed funding to confront the opioid epidemic.

The 21st Century Cures Act had the support of patients, researchers, universities, and a broad political constituency. But there is a catch. In several key ways—including notably the use of surrogate markers instead of better forms of evidence to show the drug benefits—the Act threatens public health by lowering U.S. Food and Drug Administration (FDA) standards for new drugs and medical devices.

The Act was originated and promoted by the major pharmaceutical companies who employed over 1,300 lobbyists to promote the bill. The companies were concerned that FDA used strict methodological standards to evaluate the efficacy and safety of new pharmaceutical products. The companies argued that zealous concern for efficacy and safety deprived patients of new cures, and they succeeded in adding provisions to the Act that allow FDA to become less rigid.

Opponents were concerned that the Act deemphasized methodologies that have long been used to evaluate the safety and efficacy of new drugs. Indeed, supporters of the Act hoped to reduce reliance on the double-blind randomized clinical trial, the gold standard for establishing that medicines cause improvements in health outcome. Pharmaceutical companies regarded these methods as outdated and suggested that new drug licensing should depend on preclinical studies, including animal studies, case histories, and in some cases just the clinical experience of doctors. As it turns out, the companies’ suggestion became reality. The Act now includes a provision that allows for the consideration of “real world evidence,” which includes “sources other than randomized clinical trials.” Some of these alternative methods are associated with established biases.

Many health care researchers, including me, believe that relaxing methodological standards will put the public at risk. Risks take several forms. All drugs have potential benefits and side effects. Several systematic reviews suggest that as standards for conducting and reporting clinical trials tightened, the studies became less likely to show that treatments offer benefits to patients. Overestimating treatment benefits may harm patients by subjecting them to side effects for treatments that may not help them. When side effects are underestimated, patients may not be aware of the potential harms their medicines may cause.

Here is the crux of the issue: People use medications because they want to live longer and to feel better. Over the last few decades, FDA has put greater emphasis on measures of health outcome that are important to patients, such as length of life and quality of life.

However, drugs and devices are often evaluated on the basis of surrogate markers, including clinical lab tests that evaluate blood chemistry or tumor characters. These surrogates can be important if they are closely associated with health outcomes. But the surrogates are often uncorrelated with measures that are meaningful to patients.

For example, glycosylated hemoglobin is a good marker of diabetes control. Yet in some systematic clinical trials, patients who achieve lower glycosylated hemoglobin through aggressive medical management have a higher probability of death than those receiving usual care.

Diana Zuckerman and her colleagues at the National Center for Health Research recently studied the approval of new cancer drugs by FDA between 2008 and 2012. Among 54 new drug approvals, 36 had been evaluated on the basis of surrogate markers. In cancer studies, the surrogate measure is often tumor shrinkage. We might assume that a drug that shrinks tumors—the surrogate measure—should help people live longer higher-quality lives—the outcome. Yet, Zuckerman and her colleagues found that, for 18 of the 36 drugs, there was no evidence of improved life expectancy. The manufacturers never reported data on survival for another 13 of the drugs. It can be assumed that the companies would have reported improved survival data if such evidence existed. So, for 31 of the 36 of newly-approved cancer drugs, there was apparently no evidence that the treatment increased life expectancy.

The 18 drugs that did not improve life expectancy would still be valuable if they improved quality of life. But Zuckerman and her colleagues found only one was associated with any evidence of improved life quality. Of the 18 drugs, 15 did not improve quality of life and the remaining two drugs actually made quality of life worse. Even though the great majority of these new cancer drugs were unassociated with any benefits from the patient’s perspective, many continue to be used and are sold at a very high price. One of the drugs that reduces quality of life and does not increase life expectancy is sold for approximately $170,000 per person per year.

There at least three ways that focusing on surrogate markers rather than health outcomes can have a large negative impact on how we appraise the net benefit of medical interventions.[…]

See the original post 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.

NCHR Breast Implant Patient Checklist

National Center for Health Research


We are urging the FDA to include a black box warning about the risks of cancer and other serious health problems for women considering breast implants.  As suggested by thousands of cancer patients and augmentation patients, we are also urging the FDA to require a Checklist to be read and signed by all patients, to make sure they are aware of the many risks of breast implants.

See the checklist here or below:

BLACK BOX WARNING

Breast implants can cause a type of cancer of the immune system called BIA-ALCL (Breast implant associated anaplastic large cell lymphoma). Augmentation patients, reconstruction patients, and women with silicone or saline breast implants have developed this rare disease, which can be fatal if not caught early. Almost all women who developed BIA-ALCL had textured breast implants.

In addition, research suggests that women with breast implants have a small but significant increase in their chances of developing certain autoimmune or connective tissue diseases. Thousands of women with silicone gel or saline breast implants have reported debilitating symptoms that are typical of autoimmune, neurological, rheumatologic, or connective tissue diseases, such as joint or muscle pain, fibromyalgia, mental confusion, and painful skin conditions. Most recover significantly when their implants are removed and not replaced.

BREAST IMPLANT PATIENT/DOCTOR CHECKLIST

There are patients with silicone or saline breast implants that have experienced health problems, including cancer. These are in addition to surgical risks such as infection, necrosis (skin death), or problems with anesthesia. The purpose of this checklist is to provide information for patients considering breast implants, so that they can carefully weigh the risks and benefits of breast implants and make the decision that is right for them.

After reviewing the Patient Information Booklet, please read and discuss the items in this checklist with your surgeon. You should not initial or sign the document, and should not undergo the procedure, if you do not understand each of the issues listed below.

How long do breast implants last?

I understand that breast implants are not expected to last for the rest of my life and are likely to break within 10-15 years. Although less common, some break within just a few months or years. It is likely that I will need other surgeries related to my breast implants over the course of my life and if I am a cosmetic surgery patient these surgeries will probably be at my own expense and not covered by health insurance. These additional surgeries and procedures can include implant removal with or without replacement, muscle and tissue repair, scar revisions, MRI diagnostic exams, or other surgeries. I understand that undergoing multiple surgeries may increase my chances of scarring and permanent breast deformity.

Patient Initials____________

Who shouldn’t get breast implants?

I understand that the safety of breast implants has not been established for people who have autoimmune symptoms or diseases, or a family history of those diseases. Breast implants may be more likely to cause serious health problems for those people. In addition, breast implants are not safe for anyone with a weakened immune system or certain genetic traits, most of which are not yet identified.

Patient Initials____________

Chemicals and Metals in Breast Implants

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

Patient Initials____________

Rupture and Leakage

I understand that most breast implants will eventually rupture, usually within 10-15 years. When a saline implant ruptures, it usually deflates quickly. When a silicone gel implant ruptures, I may not notice any changes and the rupture may not be detected by my doctor or by MRI or sonogram. I understand that an MRI is recommended for silicone gel breast implants 3 years following surgery and every 2 years after that to check for silent rupture, and that these MRIs are not usually covered by health insurance. I understand that silicone can migrate from my implant into nearby tissues such as the chest wall, lymph nodes under the arm, upper abdominal wall, and into organs such as the liver or lungs where it cannot be removed. Since migrated silicone can cause health problems, ruptured silicone gel implants should be removed as soon as possible. I understand that, if needed, treatment of these conditions may be at my own expense and not covered by insurance or a manufacturer warranty.

Patient Initials____________

ALCL (Anaplastic Large Cell Lymphoma)

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

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

Patient Initials________________

Symptoms of “Breast Implant Illness”

I understand that tens of thousands of women have reported that they have experienced debilitating health problems associated with their implants, either immediately after getting implants or years later. These often include many different symptoms, such as: joint and muscle pain or weakness, memory and concentration problems, chronic pain, depression, fatigue, chronic flu-like symptoms, migraines, or rashes and serious skin problems.

Studies of thousands of women with implants have shown that they are significantly more likely to be diagnosed with one or more of the following diseases compared to other women:

  • Chronic Fatigue Syndrome – a serious, long-term illness that causes severe, long-term fatigue that makes it difficult to function.
  • Multiple Sclerosis (MS) – a nervous system disease affecting the brain and spinal cord.
  • Rheumatoid Arthritis (RA) – pain, swelling, stiffness and loss of function in the joints.
  • Sjögren’s syndrome – an autoimmune disease that causes dry mouth and dry eyes.
  • Systemic Sclerosis/Scleroderma (SSc) – a group of diseases that cause abnormal growth of connective tissue and can result in hard skin and painful joints.

Although women who develop these symptoms or diseases can’t be certain that they were caused by breast implants, research suggests that most symptoms disappeared or improved significantly after having their implants and capsules removed.

Patient Initials____________

Capsular Contracture

I understand that the most common complication of breast implants is when the scar tissue capsule that forms around the implant hardens or squeezes the implant. In some cases, this can be very painful, distort the shape of the breast, and can make mammography painful and very inaccurate. Implant removal is the only recommended way to fix this problem.

Patient Initials____________

Breast Cancer

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

Patient Initials____________

Interference with Breastfeeding

I understand that breast implants and breast surgery may interfere with my ability to successfully breastfeed.

Patient Initials____________

Loss of Sensation to Breast or Nipple(s):

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

Patient Initials____________

Cosmetic Complications: Asymmetry, Implant Displacement, Ptosis

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

Patient Initials____________

CONFIRMATION OF DISCUSSION OF RISKS

Patient: I acknowledge that I have received and read the Breast Implant Patient Information Booklet and this checklist. I have had time to discuss the information in both with my doctor, and understand the benefits and risks of the implants and surgery.

___________________________________________________Patient Signature & Date

Physician: I acknowledge that I have discussed the benefits and risks of breast implants as described in the Breast Implant Patient Information Booklet and this checklist. I have encouraged the patient to ask questions, and answered all questions accurately.

___________________________________________________Physician Signature & Date

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.