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Women express concerns about the safety of breast implants

What these efforts may be – such as leaflets, black box warnings, or a ban on certain implants – remains to be seen, while women who claim to have contracted breast implants hope for change.

A According to an article published in the journal Plastic and Reconstructive Surgery this month, a link between breast implants and systemic diseases including autoimmune diseases was reported in the 1960s.
  FDA overhauls approval procedures as medical devices come under attack

Many plastic surgeons reported on patient satisfaction with breast implants, but agreed that patients have all the latest information should be able to make a decision in the selection process. One surgeon asked the FDA to restrict the sale of breast implants to only board-certified plastic surgeons.

Some patients in the hearing requested that structured surface implants should be withdrawn from the market, mandatory tests for health risks associated with breast implants, and improved communication and informed consent about the risks and benefits of breast implants, such as a warning sign ,

New York-based photographer Nadia Dara Diskavets, who was not involved in the FDA meeting but knows about firsthand breast implant disease, wants to get a warning sign and a waiver on patients before undergoing breast implantation. These include the latest information on health risks, including the potential risk of breast implant disease or an adjuvant-induced condition known as autoimmune / inflammatory syndrome.

"The surgeon must inform the patient that he is aware of the potential risks and symptoms associated with breast implant disease, so if they experience symptoms that often mimic other autoimmune problems, they are aware of the possibility of that their implants are the cause and that they can heal by removing the implants, "said Diskavets. [19659006InBezugaufdieBesprechung"MeineSorgeistdassdieFDAplastischeChirurgenumKommentarezurSicherheitvonImplantatenbittetMeinesErachtenshabensiezudiesemThemakeinWissen"sagtesie"FürvieleFrauendauertesimDurchschnittfünfbissiebenJahreumeinesystematischeAutoimmunreaktionaufImplantatezuentwickelnBisdahinsindFrauenlangenichtmitihrenChirurgeninKontaktoderwissennichtdassImplantatedieUrsacheseinkönntenHolenSiesichdieseRückmeldung"

The open to the public meeting came just days after the FDA had issued warning letters two breast implant manufacturers, Mentor and Sientra because it meets the requirements of the agency for long-term implementation failed to comply with studies evaluating the safety and risks of their silicone-gel-filled implants.
Following the warning, Mentor said in a statement, "Nothing is more important to mentors than the health and safety of women who choose breast implants and mentor behavior. Long-term clinical trials to monitor the safety and performance of our products." [19659010] Last year, Sientra announced that new data show that its growing portfolio of implants and expanders represent safe and innovative options for surgeons and patients undergoing aesthetic or reconstructive breast surgery.

Four Women, Eight Implants. Similar Symptoms.

Discavets got their breast implants for cosmetic reasons in 2010, and the first few years went well – until they developed symptoms six years later, including one rapid heartbeat, shortness of breath, extreme fatigue, brain fog, drowsiness, allergies, premature ovarian failure and gastrointestinal problems.

  Nadia Dara Discavets received breast implants in 2010 and says she causes pain and fatigue among other health problems.

"I was exhausted all the time. My body had particularly constant pain on my hips, so much so that I could not sit for more than 15 minutes. My stomach hurt constantly. I became allergic to many foods that I had eaten just a few months before, "she said, seeing doctors, but none of them had a diagnosis for them

Then she saw someone on Facebook about breast implant disease – and the Posten described some of her own health problems.

Diskavets immediately believed that she found answers to why her health was deteriorating, and last year she had her breast implants removed, and within a month the majority of her symptoms had disappeared.

Discavets is a member of a Facebook group called Breast Implant Illness and Healing by Nicole, which has more than 70,000 women "who struggle with the same symptoms," she said.

"Many had to struggle for years without knowing that implants This could be the cause, and many heal after the explantation "while the implants are being removed, she said." That's why it's for everyone who Implants have, so important, that they learn about it. So, when they experience the symptoms, they can heal by explanting. "

  Kate Nunn received breast implants in 2014 after a mastectomy for breast cancer, which were later experienced rash, digestive problems, and nausea.

But that was not her only complication. Nunn also got rashes, digestive problems and nausea. "I thought I had food allergies because everything I ate made me sick," she said.

After learning about a breast implant disease from a friend, Nunn removed one of her implants in September and the other removed this month. She added that her surgery revealed that her implant had been ruptured.

"As cancer patients, we are the ones I feel we are really taking advantage of," said Nunn, recovering after her last surgical intervention.

Both procedures were painful and expensive. She said.

"It is easy to blame the plastic surgeon, but these surgeons are told by these manufacturers that these implants are safe and they are the best of the best … What I hear is just fair said Nunn, who was not involved in the FDA meeting.

From the manufacturers, she said, "I would love to be held accountable and certainly to make amends for the women who suffered also the process, testing and testing for safety … Especially the textured implants, these things must be banned.

  Jessica Everett had health problems two years after the onset of breast implants, and she hopes to raise awareness of breast implant disease.

Jessica Everett, a Houston-based businesswoman and service woman, received her breast implants two years ago, and she has had inflammation within three months She also had fatigue and some memory loss.

She saw several doctors, and "a year after implants, I was diagnosed with four different autoimmune diseases without a family history," Everett said

While browsing Facebook, she came across a "random post", describing the condition related to breast implants, and recognized that the post described her own health problems that included 57 symptoms. She had her implants removed in February.

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

99% of my symptoms were completely gone after removing their implants Within a week and within one and a half weeks, I did not take any medications, "said Everett, who did not attend the FDA meeting but submitted a comment.

"The takeaway message is really dangerous for us to get the implants because we do not know how they will affect us. Some women do not affect them – my mother has implants and they did not affect them – but they affected me. "She said," The medical community just needs to be educated to help other women diagnose and prevent. "

Valerie Lenie, the Kansas City-based administrator of the Facebook group Breast Implant Lawsuits, received her breast implants from Cosmetic In the years that followed, she developed food allergies, joint pain, gastrointestinal complaints, and shingles, and contracted mononucleosis twice.

"I've never had Mono," she said, adding that she had an MRI scan Assessing health issues and showing that silicone penetrated her body from her implant, Lenie was shocked.

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

"So if a woman has implants and she has many unusual symptoms or she does not feel well and no one can look up what's wrong with her after she went to several doctors is, "she said," I want people to think about it Maybe it's their breast implants and that to examine.

Lenie, who attended the FDA meeting, is now launching the Facebook group to collect and share information that benefits women who are pursuing a breast implants complication trial, with 5,826 members on Tuesday.

"The old model of doing things … was disappointing"

"We have heard absolutely that the women have spoken. It has been very compelling testimony, and we partner with them in the long-term results of the implants, their safety, their health and well-being, "said Dr. Alan Matarasso, president of the American Society of Plastic Surgeons, for the FDA hearing. The company, which represents about 93% of all board-certified plastic surgeons in the United States and thousands worldwide, appreciates the continued debate on the safety of breast implants, said Dr. Andrea Pusic, president of the Plastic Surgery Foundation, the Institute supports research and international activities of society.

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

  How Surgeons Build New Breasts

The company has updated its website several years ago to include additional resources for patients and Doctors in relation to the breast implant-associated anaplastic large cell lymphoma.
The group collaborated with the FDA to establish a registry in which cases of lymphoma-linked breast implants were created in 2012 and last year an entire national breast implant registry registry in the United States.

"The National Breast Implant Registry is, in our opinion, our best way to ensure the safety of breast implants in relation to our concerns," said Pusic at the FDA meeting on Monday.

"The old model of doing something with the large follow-up studies was disappointing," she said. "Registers are really the way forward."

Last year, 313,735 breast augmentation procedures were performed in the United States, an increase of 4% from 300,378 procedures in 2017, according to data released by the plastic surgeon company this month. [19659011] Although many women have no problems with breast implants, up to 20% of augmentation implants require implants removed within eight to ten years due to complications, the FDA said.
"Breast implants are not meant to be lifetime devices, they have lifetimes of seven to over ten years, based on the implant and the patient." Tommaso Addona, plastic surgeon and president of New York's Long Island Plastic Surgical Group, who was not involved in the FDA meeting, previously told CNN.

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

"We discuss complications The implant, sometimes pain and discomfort from the implant … until the last seven years, probably a little more, we have become more aware of a particular type of lymphoma associated with breast implants," he said. "What the general public appreciates is that, as physicians and clinicians, we always want the best and safest for our patients, we not only train ourselves but also educate our patients."

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