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Washington – US health authorities will allow a type of breast implant linked to a rare form of cancer remain on the market, saying that its risks do not justify a national ban.
The Food and Drug Administration announced on Thursday that it was considering bold caveats for implants and demanded a tighter reporting of the problems faced by manufacturers. This announcement is the latest in decades of government efforts to manage implant risks and complications that may include scars, pain, swelling, and rupture.
In recent years, the FDA and other regulatory agencies around the world have discovered the recently confirmed link with a rare cancer and the thousands of unconfirmed complaints about other health issues that women attribute to implants, including arthritis, fatigue and muscle aches.
FDA regulators said in a statement that, although they do not have definitive evidence of the involvement of these chronic conditions by implants, women who plan to use them "should be aware of these risks." To this end, the agency indicated that she would consider adding a boxed warning – her most serious type – to breast implants and a checklist describing the various potential damages to the patients who are breastfeeding them. plan.
Earlier this month, the French authorities published a rare ban on breast implants associated with a form of lymphoma, including those sold by the manufacturer Allergan. The director of medical devices at the FDA said that the agency was not ready to take this step.
"At the moment, the FDA does not believe that, based on all the data and information available, the device meets the ban standard," said Dr. Jeffrey Shuren in a statement.
The cancer associated with implants is not breast cancer but lymphoma that develops in the scar tissue surrounding the breasts. Almost all confirmed cases involve a type of textured implant designed to prevent slippage and minimize scar tissue.
Shuren said the variety accounted for less than 10% of the US market, consisting mainly of smooth implants. He noted that there had been cases of cancer with smooth implants, raising questions about the fact that several factors contribute to the disease.
There have been more than 600 cancer cases worldwide, out of about 10 million women with implants.
Kimra Rogers is one of those women. He was diagnosed with a case of anaplastic large cell lymphoma associated with a breast implant after noticing a lumen under his arm.
"I could smell a mass the size of an egg, it was an egg for a lemon [sized]she was very fat, "she told" CBS This Morning "in 2017. She learned that it was a cancer, probably related to cosmetic breast implants that were not found in her body. she had set up 17 years ago.
"I have never been informed that I could possibly have cancer.They said they were 100% safe," Rogers said.
Diana Zuckerman, who studied the safety of breast implants, said that a ban might not be necessary to phase out textured implants.
"I think a lot of doctors will avoid them and patients will say they do not want them," said Zuckerman, president of the National Center for Health Research, a non-profit organization, who evaluates studies and conducts his own research.
Breast augmentation is the most popular form of cosmetic surgery in the United States, with approximately 300,000 women undergoing the procedure each year. Another 100,000 women receive implants for breast reconstruction after a cancer operation.
In an effort to "promote greater public transparency," the FDA also said Thursday that breast implant manufacturers would no longer be allowed to summarize routine injuries and complications in grouped reports. Manufacturers are required to report all serious injuries, malfunctions and deaths related to their devices. However, as part of FDA's alternative summary notification program, breast implant manufacturers and other manufacturers could file quarterly updates representing thousands of incidents, most of which are unclear. Were not listed in a public database.
This practice – which the FDA is committed to phasing out – has been criticized for obscuring the actual number of incidents reported to regulators. Reports submitted to the FDA include submissions from companies, physicians, patients, and lawyers often including incomplete unverified information and duplicates.
Prior to the March meeting, the FDA revealed for the first time that it had received more than 350,000 reports of breast implants over the last decade.
According to Madris Tomes, a former FDA staff member who founded a company to analyze medical device reports, the number of reports visible in the agency's searchable database is about seven times higher.
"There are more than 300,000 non-serious malfunctions and injuries, these should be publicly available and allow it to decide if they are serious." Said Tomes.
Mass reports regarding other medical devices are allowed under a new program that plans to make them public.
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