Women worry about the safety of breast implants

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What these efforts may be – such as pamphlets, black box warnings or a ban on certain implants – remains to be seen, while women who claim to have been sick of their breast implants are hoping for a change.

A link between breast implants and a systemic disease, including an autoimmune disease, has been reported since the 1960s, according to an article published this month in the journal Plastic and Reconstructive Surgery.
FDA revises approval process while medical devices are under fire

At the meeting, many plastic surgeons indicated that patients were satisfied with breast implants, but agreed that patients should have all the information up to date to be able to make an informed choice. A surgeon has asked the FDA to limit the sale of breast implants to only certified plastic surgeons.

Some patients have requested that textured surface implants be removed from the marketplace, mandatory breast implant health testing, and improved communication and informed consent regarding the risks and benefits of breast implants, such as breast implants. breast implants. caution.

New York-based photographer Nadia Dara Diskavets, who did not attend the FDA meeting but knows about breast implant disease, would like to see a warning label and dispensation given to patients before surgery. This would include the latest information on health risks, including the potential risk of breast implant disease or a health problem called autoimmune / adjuvant-induced inflammatory syndrome.

"The surgeon must have the patient sign that she is aware of the risks and symptoms associated with the disease of breast implants.Therefore, if she has these symptoms that often mimic other autoimmune problems, she is aware of the possibility that her implants are the cause. " and that they can heal by removing the implants, "Diskavets said.

Regarding the meeting, "I am concerned that the FDA is asking plastic surgeons for their comments on the safety of the implants, which I do not think they have any knowledge of," she said. "For many women, it takes an average of five to seven years to develop a systematic autoimmune response to implants. At that time, women are long disconnected from their surgeons or are unaware that implants may be the cause. get this back. "

The meeting, which was open to the public, was held just days after the FDA sent warning letters to two breast implant manufacturers, Mentor and Sientra, for failing to meet the agency's requirements. wanted long-term studies on the safety and risks of their products. implants filled with silicone gel.
After the warning, Mentor said in a statement that "nothing is more important for Mentor than the health and safety of women who choose our breast implants and Mentor is conducting long-term clinical studies to monitor the safety and performance of our products. "
Last year, Sientra announced that new data indicated that its "growing portfolio of implants and expansion devices were safe and innovative options for surgeons and patients undergoing cosmetic surgery or reconstructive breast ".

Four women Eight implants. Similar symptoms.

Diskavets had her breast implants for aesthetic reasons in 2010 and the early years went well – until six years later, when she quickly began to develop symptoms, including an increased heart rate, shortness of breath , extreme fatigue, brain fog, dizziness, allergies, premature ovarian failure and gastrointestinal problems.

Nadia Dara Diskavets had breast implants in 2010 and says it caused her pain and fatigue, among other health problems.

"I was exhausted all the time, my body was in constant pain, especially my hips, so much so that I could not sit more than 15 minutes, my belly ached all the time. allergic to many foods that I liked to eat a few months ago, "she said She saw doctors, but none of them had been diagnosed.

She then saw a Facebook post on breast implant disease – and described many of her own health issues.

The Diskavets immediately thought they had found answers to why his health was deteriorating and last year his breast implants were removed. After a month, the majority of his symptoms are gone.

Diskavets is a member of Nicole's Facebook group entitled Breast Implant Illness and Healing, which has more than 70,000 women "who suffer from the same symptoms," she said.

"Many have struggled for years without knowing that implants could be the cause, and many have healed after explant surgery," she said. "That's why it's so important that all implant recipients are aware of the situation, so if they feel the symptoms, they can heal by explant."

Kate Nunn had breast implants in 2014 after a mastectomy for breast cancer, followed by rashes, digestive problems and nausea.

Kate Nunn, a Dallas-based bakery owner, had her breast implants in 2014 after a mastectomy for breast cancer, on which she was diagnosed in 2013.

In the years that followed, scar tissue formed around the implant, causing a complication called capsular contracture, which, according to Nunn surgeons, was due to the radiotherapy that she was receiving for her Cancer.

However, it was not his only complication. Nunn also started having rashes, digestive problems and nausea. "I was thinking of developing food allergies because everything I ate made me sick," she said.

After hearing about a disease related to a friend 's breast implants, Nunn had one of her implants removed in September and the other this month. She added that her operation revealed a rupture of her implant.

"As cancer patients, we are the ones who, in my opinion, are really being exploited," said Nunn, who is recovering from her last surgery.

Both procedures were painful and expensive, she said.

"It's easy to blame plastic surgeons, but these manufacturers are telling manufacturers that these implants are safe and that they are the best of the best. … After what I've heard say, this is just not true, "said Nunn, who did not attend the FDA meeting.

Among the manufacturers, she said: "I would love that they are held accountable and that they repair the women who have suffered suffering, but that they also reorganize the process, the testing process and safety tests, implants, these things should be prohibited. "

Jessica Everett had health problems after having breast implants two years ago. She now hopes to raise public awareness of breast implant related diseases.

Jessica Everett, Houston-based businesswoman and housemaid, had her breast implants two years ago. After about three months, she said, she was starting to have an inflammation of her hands – so much so that she needed surgery. She also suffered from fatigue and memory loss.

She consulted with several doctors and, "one year after implant placement, four different autoimmune diseases were diagnosed, with no family history," Everett said.

Then, while browsing Facebook, she discovered a "random message" describing a disease related to breast implants and realized that this message described her own health problems, which included 57 symptoms. She had her implants removed in February.

"I'm already back in my uniform at the military base today," Everett said Tuesday.

After the removal of his implants, "99% of my symptoms completely disappeared within a week and in a week and a half, I was not taking any medication," said Everett, who did not attend the meeting. the FDA but submitted a comment. .

"The message to remember is that it's really dangerous for us to get implants because we do not know how they will affect us." For some women, this does not affect them – my mother has implants , and they did not affect her – but they affected me, "she said. "The medical community just needs to be informed about this in order to help other women with diagnosis and prevention."

Valerie Lenie, a director of the Kansas City-based Breast Implant Lawsuits Facebook group, had her breast implants for aesthetic reasons in 2008. In the following years, she developed food allergies, joint pain, gastrointestinal problems, and shingles and contracted mononucleosis twice.

"I had never had a mono before," she said, adding that she had an MRI to evaluate her health problems. The latter revealed a leak of silicone from his implant in his body. Lenie was in shock.

She had her implants removed in 2017 and said that she was fine since.

"So, if a woman has implants and that she has a lot of strange symptoms or that she is not feeling well and that no one can understand what's wrong with her after consulting several doctors, she says, "I want people to consider that it may be the case for her breast implants and to consider that."

Lenie, who attended the FDA meeting, is now leading the Facebook group to collect and share information that would be useful to women in breast implant complications litigation. On Tuesday, the group had 5,826 members.

"The old model of doing things … was disappointing"

"We absolutely heard from the women who spoke, this testimony was very convincing and we are working in partnership with them to determine the long-term results of implants, their safety, their health and their well-being," he said. Dr. Alan Matarasso, president of the American Society of Plastic Surgeons, said about the FDA's hearing.
The company, which represents approximately 93% of all certified plastic surgeons in the United States and around the world, appreciates the ongoing debate about the safety of breast implants, said Dr. Andrea Pusic, president of the Plastic Surgery Foundation, that supports the research of society. and international activities.

"We think it's important," she said.

How surgeons build new breasts
The company updated its website a few years ago to include additional resources for patients and physicians regarding anaplastic large cell lymphoma associated with breast implants.
The group worked with the FDA to create a registry to track cases of lymphoma-related breast implants in 2012 and, last year, to create a national registry of breast implants in the United States.

"We believe that the National Breast Implant Registry is our best way to ensure the safety of breast implants with respect to the concerns we hear," said Pusic, who spoke at Monday's FDA meeting. .

"The old model of working with large post-approval studies has been disappointing," she said. "Registers are really the way to go."

Last year, 313,735 breast augmentation procedures were performed in the United States, an increase of 4% from the 300,378 procedures in 2017, according to data released by the plastic surgery company this year. month.
Although many women have problem-free breast implants, as many as 20% of augmentation implants have their implants removed within eight to ten years due to complications, according to the FDA.
"Breast implants are not meant to be used for life – they have a lifespan that can range from seven to ten years and more, depending on the implant and the patient," said Dr. Tommaso Addona , plastic surgeon and president of Long Island. Plastic surgery group in New York who did not attend the FDA meeting, had previously told CNN.

He added that he often discusses the benefits and risks of breast implants with his patients.

"We are discussing complications, which range from scarring around the implant, sometimes going through the pain and discomfort of the implant … to the last seven years, probably a little Plus, we have become more aware of a specific type of lymphoma that is associated with breast implants, "he said. "What the general public should appreciate is that physicians and clinicians always want the best and safest for our patients." We are constantly educating ourselves not only ourselves, but also our patients. "

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