All posts by BIadmin

Nancy Gallegos


California

Hello,

Thank you for allowing me the chance to share my story with your respected panel. My name is Nancy Gallegos. I traveled here from Fresno, Ca. at my own expense, so I have no conflict of interest.

I decided at the age of 24 to get my breast implants. I was young, very vulnerable, and just knew this would change my confidence for the better! Self-esteem was all I wanted.

So I was implanted with Allergan Textured Saline Implants. And if I might add, I am still sick with these today. One might say, “But you look just fine”. For me, this is just a mask. Internally I am suffering.

My health issues started 6 years ago. For many years, I lived symptom free. Until 2013, when all things came crashing down.

The once upbeat, motivated, very confident woman had now turned into a woman who could not get up off her couch, drive her daughter to school, or pass a mandatory test at her job in order to stay employed.

My husband used to describe me as an independent, motivated, and extremely outgoing. Anyone that knows me would say the same. Now he sadly feels this illness has consumed my life. My illness is all I talk about. And he would like the old me to come back! Even though he supports me, I know I’m not the same person he married 10yrs ago.

Today I am asking for proper informed consent. I feel we should be provided very crucial information before implanting, and at that point, the patient can make their own decision whether or not they would like to proceed. One thing I might add is, it’s very difficult going to see your physicians because we are so ill & they have no idea what Breast Implant Illness is. Therefore, many incorrect diagnosis are given with medication prescribed that has no effect.

I myself deal with depression, weight gain, joint pain, insomnia, auto immune disease, Vitamin D Deficiency, anemia, high blood pressure, memory loss, and much much more. I am so thankful a friend directed me to the Breast Implant Illness page, because now I felt like I belong somewhere. These women are dealing with the same issues I have been crying about for years! This page has given me insight as to what no doctor has been able to explain or diagnose. I am a woman in my 40’s that has to walk around with a pill box everywhere I go! Numerous medications with no ultimate effect.

I cannot wait to explant! However, the cost to remove my implants costs almost double what I paid to get them in. Health insurance makes it near impossible to cover. Why do I pay thousands of dollars on an expensive PPO Insurance, yet get denied coverage for explant when i’m extremely ill. I just want my health back!

In closing, I ask you today, to please listen & know we are women in a world of struggle. I would hope that if you had a wife, child, or family member crying out for your help, and they too have breast implants, please listen and know these implants are making women deathly ill, and changing our lives entirely!

Thank you.

Nancy testified at the FDA Advisory Committee on breast implants in March 2019.

Robyn Towt


My name is Robyn Towt. I am a breast cancer survivor. I was diagnosed in 2017 and I had a double mastectomy and reconstruction with Mentor Silicone breast Implants. I did not have chemotherapy or radiation treatment, nor did I take hormone therapy drugs, I only did surgery. I was feeling just fine until the implants were put into my body, they made me horribly ill. I’ve had three cancers in my life of 46 years and having breast implants were worse than all three cancers put together. I suffered the entire time that I had them in with the following symptoms:

headaches/migraines, heart palpitations, difficulty breathing, difficulty swallowing, skin rashes, hair loss, joint pain, extreme fatigue, physical therapy 3 times a week, anxiety, choking feeling, chest pain, burning pain, red eyes, chronic inflammation, dizzy/lightheaded, insomnia

I went back to my surgeon 4 times and she said it wasn’t from my implants, and that my implants are safe. I also wasn’t given the patient information brochure prior to getting my implants. ALL of the health issues that I was experiencing are outlined in that booklet. If I had that booklet, I would have been able to determine the cause of my failing health much sooner.

Another breast cancer lady shared with me how her implants made her sick, leaving her bedridden and unable to work. Her story resonated with me and sounded remarkably similar to mine. So I removed them after just 4 months and every single symptom has resolved. I then became a member and administrator of the FB group Breast Implant Illness and Healing by Nicole.

Over 75,000 women in our group have had a similar experience. In a recent survey of over 2,300 women, 83% said they were not given the patient information brochure, 83% said they did not feel they understood all the risks at the time, and 97% said they weren’t given enough time to make an informed decision. This is not acceptable.

I work closely with the AZ Society of plastic surgeons. The four board members of that society told me that they don’t give the booklet to every patient because they only get a couple of booklets in each shipment of breast implants. I also contacted

a mentor rep who confirmed that only a few booklets are given with each shipment, but the surgeons can request more and they will be provided. Part of the premarket approval agreement between the breast implant manufacturers and the FDA in 2006 was that EVERY single patient was to get that patient information booklet.

None of this information is new. The FDA has been hearing all of this…FOR DECADES. These same stories of sick women pleading for help. Women are not being properly informed and breast implant manufacturers are not being held accountable. Something needs to be done to remedy this situation. It is very difficult to be optimistic about solving this problem when the SYSTEM has COMPLETELY FAILED us for DECADES.

SOMETHING needs to change, this is a global women’s health crisis.

In March 2019, the FDA released that the implant manufacturers have clearly violated the conditions of their PMA. I implore the FDA to revoke the premarket approval that was given to the breast implant manufacturers in 2006. There should be consequences for these violations, otherwise the safety studies will never be completed and women will continue to suffer.

In the meantime, in order to protect women and give them proper information to make an informed medical decision, I am suggesting implementing the following…for FULLY INFORMED CONSENT.

  • Mandatory Patient Information booklet
  • Mandatory Patient/Doctor Checklist (see attached)
  • Mandatory Chemical Ingredient list
  • Black box Warning Statement including ALCL and autoimmune
  • Mandatory testing explant patients for ALCL at implant manufacturers expense
  • Continuing education for surgeons on how to properly remove implants
  • NBIR to include explant patients retrospectively, following and monitoring symptoms pre and post explant.
  • Health Care Provider Letter to physicians, clinicians and surgeons stating that breast implants cause autoimmune diseases
  • IMMEDIATE BAN AND RECALL of all textured breast implants
  • Funding for awareness of Breast Implant Illness and ALCL

For the breast implant manufacturers I suggest…

  • Compensation and reimbursement for explants of theTHOUSANDS of women who have suffered autoimmune and health issues and CANCER from implants that were deemed “safe”. The manufacturers need to be held accountable.

Robyn testified before the FDA Advisory Committee on breast implants in March 2019.

Julie


Quebec, Canada

My name is Julie and I’m from Quebec Canada.

I had Mentor smooth cohesive gel implants from 10 years.

When I decided to get breast implants, I knew every surgery had risks and that

implants could rupture or cause contracture.

But my surgeon said that the newest generation of implants were impossible to rupture, and  the cohesive gel would never leak.

Implants transformed me from an athlete with a full-time job to a full-time patient.

3 weeks after getting implants I noticed the first changes in my health.

I experienced extreme exhaustion, rapid weight gain, paralyzing brain fog, and in

tolerance to sound and heat.

Nine months after getting my implants, I was diagnosed with Hashimoto’s disease.

Later on I experienced muscle pain so severe I had to stop exercising. My hair was falling out and I was always thirsty. I was also diagnosed with asthma.

I then developed food intolerances and allergies. My throat was closing up after each bite and my gastro-intestinal issues became so severe that I had to stop working.

In 2016, I read about Breast Implant Illness. I had been searching for the cause of my health problems for 10 years and it was right in front of me: I had 2 polymer bags inside of my body. I had my implants removed in January, 2018.

A month after surgery, I sent my implants and capsules to be analyzed by Dr. Pierre Blais.

My capsules were 100 times thicker than what he usually sees and were covered with granulomas.

But the most shocking was the fact that one of my implants had a small rupture of longstanding origin that had leaked silicone OIL  into my body for years.

After my explant surgery, several of my long-term symptoms disappeared almost immediately.

Today marks 14 months since my explant surgery.

While some of my symptoms still remain, I am healthier than I’ve been in years. My implants greatly compromised my health and it may take years to recover.

I decided to create the first French-Canadian support group for women affected by breast implants. The group immediately got to over 800 members an growing very day. And these members are actually 800 patients.

I stand in front of you because women are literally dying from their implants and no one believes them.

We NEED more long-term research studies on the complications from breast implants that focus on symptoms and not just on  diagnosis.

I stand in front of you because I see women fighting EVERYDAY to get proper testing for BIA -ALCL.

Health care providers need awareness on the latest developments about diagnosis, pathology and treatment of this cancer.

I stand in front of you because every day I see women who have no clue what make or model of implants they have inside their bodies.

We NEED national registries that track all health complications and not just re-operations.

I stand before you because I know the FDA can lead the way and be the role model we need.

This meeting is FDA’s opportunity to listen to what patients are saying about their experiences with implants so that public health agencies make decisions that will help shape the future health of millions of women around the globe.

Thank you for this opportunity.

Julie testified at the FDA Advisory Committee Meeting on breast implants in March 2019.

Dawn Criss


Alberta, Canada

My name is Dawn Criss and I am from Alberta, Canada, and I have travelled here at my own expense. I received my textured breast implants in 2008 when I was 38 years old and I was not warned of any link to diseases or cancer.

For 6 years I was healthy and working.  Then in 2014 I experienced intestinal issues, chronic fatigue, unexplained rashes and itching and massive hair loss. After months of suffering, my body shut down and I was hospitalized for blood loss and Severe Ulcerative Colitis.

In 2017, my left breast swelled up twice its size. My physician referred me for an ultrasound guided needle aspiration to test for Lymphoma and an MRI to look for rupture. Both results were negative.

Despite my negative tests, I decided to remove my textured implants and replace them with smooth. On December 2017, I had my first explant surgery and it was determined that I had double capsules. The left inside capsule and implant surface tested positive for BIA ALCL.  5 weeks later I had a second surgery to remove the outside capsules and the new implants.

Since my explant last January, all of my autoimmune symptoms have subsided. In the last year, I have had only one major flare up in which it took mere weeks to recover instead of months.

New patients need to know the risks of breast implants. The Directions for Use given to plastic surgeons lists numerous concerns such as autoimmune issues, gel movement without rupture and depression. This information is given to plastic surgeons, but NOT to the patient. Therefore, the patient cannot make a well-informed decision. Transparent, informed consent with a two paged surgeon/patient checklist and a black box warning should be a priority for all new patients.

Please understand that not all women have obvious symptoms of this cancer and some of them don’t know about this disease until it is too late. False negatives from fluid collection is a common occurrence that cannot be ignored and testing capsule tissue after explant can no longer be the only acceptable way to diagnosis. The long-term safety of all breast implants needs to be investigated.  This should include BIA ALCL as well as the autoimmune symptoms typical of breast implant illness.

While all breast implants can cause an immune response, textured ones have now been proven to cause this man-made cancer. Please! Take textured implants off the market! Continue studies through a non biased organization to obtain accurate data from our current patient population and include finding a more accurate way for testing and diagnosis that does not leave a patient at risk.  We need to be able to work together within our health care systems to make sure that no one is denied testing or treatment because of their financial status regardless if breast implants were an elective choice or not.

Cancer is a hard reality for many of us to deal with. It affects not only our bodies but our minds, our relationships, our working ability and our own sense of security. For even the strongest believers, it takes away HOPE. Cancer was NOT a choice and we sure as heck didn’t elect to get it.

Dawn testified at the FDA Advisory Committee Meeting on breast implants in March 2019.

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

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


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

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

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

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

 

See original story here.

FDA Stops Sales of Transvaginal Mesh for Pelvic Organ Prolapse

Michelle Llamas, Drug Watch: April 16, 2019.


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

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

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

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

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

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

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

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

That left Boston Scientific and Coloplast.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

See the original article here.

FDA Progressive Device Approval Proposal Raises Eyebrows

David Lim, MedTech Dive: April 16, 2019.


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

 

See the original article here.

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.

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.” […]

 

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