FDA authorizes sale of breast implants related to cancer and reinforces warnings

In the United States, at least 457 women have been diagnosed with cancer, according to the FDA, and nine have died. Cancer affects the cells of the immune system and is found around the breast implant.

Recognizing that international health agencies have decided to ban the sale of textured implants, the FDA said that market share in these countries could reach 80%, while market share in the United States United is minimal in comparison.

"The type of macro-textured implants targeted by some of our international counterparts accounts for less than 5% of the breast implants sold here," the agency said in a statement. "At the moment, the FDA does not believe that, on the basis of all available data and information, the device complies with the prohibition standard set out in the Federal Law on Food, Drugs and Cosmetics."

"Do not ban textured implants is very discouraging for us and for patients with lymphoma," Cook said. "We will continue to press for this ban, even if it is not a gesture that they are willing to make."

According to the American Society of Plastic Surgeons and the Plastic Surgeon Foundation, about 10 to 11 million women worldwide have breast implants.

The FDA raised the possibility of the disease in 2011, claiming that the risk of cancer after breast implant placement was small but significant. He asked the doctors they had noticed changes in their patients and urged women to look for symptoms such as a build-up of fluid or a mass around their implants. The symptoms of cancer also include swelling and redness around breast implants.

Since that report, the scientific community has learned more about the link between breast implants and anaplastic large cell lymphoma.

Improve warnings

In addition to BIA-ALCL, the agency has expressed concern about the risk of implant rupture and a condition called capsular contracture, in which the breasts become hard and misshapen, causing chronic pain and discomfort. an increase in immune system disorders.

"Concerned patients have stated that their implants may be linked to health problems involving their immune system's response to these devices, resulting in a variety of symptoms such as chronic fatigue, cognitive problems, joint and muscle pain," he said. the FDA.

While acknowledging that there was "no definitive proof that breast implants are the cause of these symptoms," the agency said that the fact that many immune problems disappear when removing implants meant that " women who are considering a breast implant should be aware of these risks. "

Labeling changes such as box warnings and a patient's decision checklist could be one of the ways in which the agency communicates some of the important health concerns related to breast implants.

These are the main changes advocacy for breast implant victims wanted, Cook said.

"The FDA has stated that it is considering these actions," she said, "but, based on the conversations we have had in recent weeks, I have a lot of trouble." hope that they pursue them. "

Fight against the notification of adverse events

Breast implant manufacturers will also face a major shift in the way adverse events are reported, the FDA announced. In the past, manufacturers could provide a summary of the patient's problems or concerns, but this method did not take into account "unusual, unique or unusual adverse events that, in the case of breast implants, included BIA-ALCL "said the FDA.

In the future, manufacturers will have to submit individual reports on adverse events that will be made public in the coming weeks, the agency said.

Device Events founder Madris Tomes, who developed a tool to search for adverse events in the FDA database, said the action "was a step in the right direction."

"It appeared that the summaries contained a lot of data that should have been available before this meeting," she said, adding that adverse data should never be disclosed to the public.

While welcoming the work of the registries in her statement, the FDA said that "more needs to be done to increase the number of health professionals contributing to registries and the types of information collected by registries." ".

The agency pointed out that she has been monitoring the risks associated with breast implants since 2011 and sees the issue as a priority.