[ad_1]
A type of breast implant linked to a rare cancer can still be sold in the United States, even though it has been banned in many other countries, the Food and Drug Administration announced Thursday.
Implants, which have a textured or slightly rough surface, as opposed to a smooth coating, have been associated with cancer of the immune system called anaplastic large cell lymphoma.
The vast majority of cases occurred in women wearing textured implants, mainly those manufactured by Allergan. But the F.D.A. said that the risk, although increased, was still low and that there was not enough data to justify the ban on implants.
He also indicated that in some patients with lymphoma, the type of implant was not known, so that smooth implants could not be excluded as cause.
Dr. Mark Clemens, plastic surgeon and lymphoma specialist at the Dr. Anderson Anderson Cancer Center in Houston, said the disease was exclusively related to textured implants. He said that there was no known case of lymphoma in the world in a woman who had only smooth implants. Some cases have occurred in women with smooth implants, he said, but they had previously textured.
He described the F.D.A. like "sin excessively to be conservative".
Around the world, he said, there have been more than 600 cases of lymphoma and about 20 deaths. In the United States, 265 cases have been reported. About 10 million women worldwide have implants, which are used for esthetic enlargement of the breast or for reconstruction after a mastectomy for breast cancer.
In the United States, only about 10% of implants are textured, but in other countries this figure can reach 80%.
The announcement of the agency followed a Two-day public hearing in March, during which researchers and implant manufacturers presented data. The women described a number of diseases that they developed after obtaining implants, including lymphoma.
The F.D.A. statement acknowledged that in some women, implants may be associated with systemic problems called "breast implant disease", which includes a constellation of symptoms such as chronic fatigue, pain, cognitive and immune problems.
"While the F.D.A. There is no conclusive evidence that breast implants cause these symptoms, but current evidence confirms that some women have systemic symptoms that may go away when their breast implants are removed, "the agency said. in a statement.
Dr. Amy Abernethy, Senior Deputy Commissioner, and Dr. Jeff Shuren, Director of the Center for Appliances and Radiation Health. "We believe that women who are considering a breast implant should be aware of these risks."
Agency officials are committed to taking steps to make women and health care providers more aware of the risks. The statement states that the F.D.A. consider requiring a black box warning – the most serious – for products and requiring physicians to consult a checklist with patients describing the risks associated with implants as part of the informed consent process prior to surgery . But the agency did not engage in these actions.
Jamee Cook, co-founder of Broke Implant Victim Advocacy, is said to be disappointed that textured implants are not prohibited. But she welcomed the proposals of F.D.A. to better inform patients of the potential risks associated with breast implants.
"There is information in the manufacturer's brochure, but it's 40 or 60 pages," Cook said. "Put it together on a piece of paper that requires the patient to sit here to read and check all these boxes, then if she still wants these implants, give her the power, it's her decision as a patient. But we want them to have all this data readily available before making their decision. "
Agency representatives also stated that they would no longer allow manufacturers to file summary reports containing dozens or more adverse effects associated with breast implants or other less accessible medical devices than those registered in the US. the database of public agencies called MAUDE. ).
But Madris Tomes, a former program manager for the agency that founded a company called Device Events, said manufacturers could still use a new summary reporting system set up in August called the Voluntary Malfunction Summary Reporting Program. .
"I have the impression that this change is only semantic," Ms. Tomes said. "What will prevent manufacturers from duplicating their behavior and doing the same thing they did before, categorizing deaths and injuries into abstracts so that they are not visible?" by the public? "
A spokesperson for the F.D.A. stated that breast implants would not be part of the new summary reporting system.
She became a patient advocate and met with F.D.A. responsible repeatedly. At the March hearing, she insisted that textured devices be removed from the market.
She praised the agency's proposals to add warnings to implant labeling and asked doctors and patients to consult a checklist describing the risks.
Noting that the agency's statement was not final, but using terms such as "would" and "could" for the proposed actions, Ms. Hollrah said, "This is progress, but we will be watching closely I can guarantee you that we are here now and we will be here in the future to ensure that this continues. "We are not leaving."
[ad_2]
Source link