Category Archives: We Are Quoted

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 Reviews Breast Implant Safety as Women Raise Concerns

Diane Ashton, Fox News: April 11, 2019.


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

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

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

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

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

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

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

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

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

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

 

See the original article here.

Leaking Breast Implants Leave Women Fighting Infections, Insurers

Ayanna Alexander, Bloomberg Law: April 8, 2019.


Insurers can deny coverage for treatment related to infections caused by breast implants, causing a budding advocacy movement.

“The insurers use the fact that there’s no true medical definition for breast implant illness as an opportunity to try not to pay for it,” said Scot Glasberg, a former president of the American Society of Plastic Surgeons.

Women who have suffered from breast implant illness are asking the FDA for help, but the agency can’t do much when it comes to insurance coverage. Leaking implants can cause a variety of illnesses, but women who need them removed face a series of obstacles from getting necessary screenings to negotiating with insurers to cover the procedures.

The FDA has taken an interest in the problem, however. It held a public meeting on the issue in March. It also flagged two implant manufacturers—Sientra Inc. and Mentor Worldwide LLC—for failing to test their products for safety and effectiveness after they were approved.

Unless breast implants leak, interrupt cancer screenings, or lead to chronic severe pain in the breasts, insurers won’t deem removal medically necessary, according to Diana Zuckerman, who heads the National Center for Health Research. “Since breast implant illness isn’t recognized, it’s not included,” she said in an interview.

Major health insurance providers such as Aetna Inc., cover some breast implant removal surgeries, but they have to be medically necessary, not cosmetic. Aetna also considers the removal medically necessary if the patient has a cancer of the immune system.

The average cost for breast implant removal surgery ranged from $5,000 to $8,000 in 2017 for uninsured patients, according to the National Center for Health Research. The average surgeon’s fee for the procedure was $2,556 in 2018, according to the American Society of Plastic Surgeons. That didn’t include anesthesia, operating room facilities, or other related expenses.

Jamee Cook, the co-founder of the Breast Implant Victim Advocacy, said it’s also difficult to get coverage for the test to determine if the implant did actually rupture.

“What we’re seeing is some insurances will cover if it’s a confirmed rupture,” she said. “The problem is not all can be confirmed. Another problem is if the implant surgery was cosmetic, most of insurers won’t cover the MRI to see if it did rupture.”

Cook had a ruptured breast implant in 2012, which caused swollen lymph nodes, fatigue, and chronic sinus infections. She ended up with an autoimmune illness and couldn’t get her implant removed until 2015.

Autoimmune illnesses or infections that come from breast implants can affect lymph nodes, lungs, saliva, and tear glands and joints. Silent ruptures, which normally occur in silicone-filled implants, are tears that leave little to no signs or symptoms because the silicone is usually trapped in the tissue that surrounds it.

Zuckerman said it’s easier to get removal or other treatment covered by insurance if plastic surgeons vouch for their patients and note the symptoms for insurers. That doesn’t always happen during consultations.

“Of, course, doctors can’t tell insurers what to cover, but a statement can say they know that women are suffering and help patients get closer to coverage,” she said

Individually, some plastic surgeons have been willing to work with insurance companies to help patients get covered. But as a whole, she said the industry has been reluctant to push to have breast implant illness recognized as a medical condition.

In his own practice, Glasberg said he notes the best code that describes the illness as it relates to implants and adds it to a bill, but the insurance company usually sends it back.

“In order to [appeal], I have to get documents from whoever the patient has been seeing to prove they’ve been dealing with [breast implant illness] symptoms,” he said. “If these other doctors can weigh in and say it could be related to the implants, that helps.”

Coverage is determined based on the patient’s medical need and circumstances for treatment, the provider and specific plan, who’s providing the treatment and where, and other medical factors according to Cathryn Donaldson, a spokeswoman for America’s Health Insurance Plans, a trade group representing insurers.

“If it is medically necessary, it is generally covered,” Donaldson said. “I would recommend patients reach out to their insurance provider if they have questions about specific benefits and/or their provider network.”

Zuckerman said women can build a better case to avoid insurance denial.

“We found that women were only asking about the symptoms associated with [breast implant illness] because that was more severe to them, even though they had leaking implants or pain,” she said. “They have to focus on and talk about what insurance companies care about covering.”

Glasberg said an FDA study on women suffering from breast implant illness will help medically define it and could even help insurers see the medical need for treatment.

“The FDA basically is in the business of studying patient safety, so that’s probably the only direction they can go,” he said. “There are many symptoms.”

He said plastic surgeons could also be a resource in tightening the “loosely defined” symptom list and “come up with a diagnosis code.” […]

 

See original story here.

France Bans Breast Implants Amid Cancer Suspicions

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


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

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

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

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

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

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

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

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

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

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

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

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

 

See the original article here.

Are Breast Implants Safe? FDA is Looking into Claims

Kris Pickel, CBS5 News: March 25, 2019.


Are breast implants safe?

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

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

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

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

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

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

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

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

See the original story and video here.

Women Need Better Information on Breast Implants, Panel Says

Laurie McGinley, Washington Post: March 26, 2019.


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

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

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

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

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

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

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

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

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

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

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

See the original story here.