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F.D.A. Will not prohibit the sale of textured breast implants associated with cancer



A type of breast implant associated with a rare cancer may still be sold in the United States, although it has been banned in many other countries, said the Food and Drug Administration on Thursday.

The implants, which have a textured or slightly worn surface, as opposed to a smooth coverage, have been associated with a cancer of the immune system called anaplastic large cell lymphoma.

Most cases have occurred in women with textured implants, mainly those made from Allergan. But F.D.A. said that the risk, although increasing, was still low and that there was not enough data to limit the ban.

It also said that in some patients with lymphoma, the type of implant was not known, so smooth implants could not be excluded as a cause.

Dr. Mark Clemens, plastic surgeon and M.D. lymphoma expert The Anderson Cancer Center in Houston said the disease was linked solely to textured implants. He said there were no known cases of lymphoma anywhere in the world in a woman who only had smooth implants. Some cases had occurred in women with smooth implants, he said, but they had previously textured.

He described F.D.A. as "celebrating on the side of being conservative."

Globally, he said, there have been more than 600 cases of lymphoma and approx. 20 deaths. In the United States there were 265 reported cases. About 10 million women around the world have implants used for cosmetic breast augmentation, or for post-mastectomy mastectomy.

Only about 10 percent of the implants used in the United States are structured, but in other countries the figure can be as high as 80 percent.

The agency's announcement followed a two-day public hearing in March, where researchers and implant providers presented data, and women described a number of diseases they developed after receiving implants, including lymphoma.

The FDA statement confirmed 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 FDA does not have definite evidence that breast implants cause these symptoms, the current evidence supports some women experiencing systemic symptoms that can be resolved when the breast implants are removed, the agency said in a statement.

It was issued by the Rector's Deputy Commissioner, Dr. Amy Abernethy, and Dr. Jeff Shuren, Director of the Center for Devices and Radiological Health, "We believe that women who are considering a breast implant should be aware of these risks."

Agency officials promised to take action To ensure that both women and healthcare professionals are better informed about the risk, the statement said the FDA would consider requiring a black box warning – the most serious – for the products and requiring doctors to review a checklist of patients describing implant risk as part of the informed consent process before the operation, but the agency does not commit to these actions.

Jamee Cook, Breast Implant Victim Advocacy, said she was disappointed that textured implants would not be banned. But she welcomed the suggestions from F.D.A. to ensure that patients are better informed about the potential risks of breast implants.

"There is information in the manufacturer's brochure, but it's 40 or 60 pages long," Cook said. "Pulls everything on a piece of paper that the patient actually has to sit here and read and tick off all those boxes, and then, if she still wants those implants, power to her, it's her decision as a patient. But we want them should have all the information readily available before making the decision. "

Agency officials also said that they would no longer allow manufacturers to submit summary reports including dozens or more side effects related to breast implants or other medical devices less accessible than those which is filed in the public agency database MAUDE (Manufacturer and User Facility Device Experience).

But Madris Tomes, a former agency presenter for the foundation of a device called Device Events, said manufacturers could still use a new summary reporting system launched in August, called the Voluntary Malfunction Summary Reporting Program.

"I feel that this change is just semantics," said Tomes. "What will keep manufacturers from duplicating their behavior and doing the same thing they did before, filing deaths and summary damages so they can't be seen by the public?"

A spokeswoman for F.D.A. said that breast implants would not be part of the new summary reporting system.

Raylene Hollrah, who was treated for implant-assisted lymphoma in 2013, said she was disappointed that F.D.A. Not imposed a ban.

She has become a spokesman for patients who face F.D.A. officials several times. At the hearing in March, she called for the textured units to be removed from the market.

She praised the agency's proposal to add implant labeling warnings and required doctors and patients to cross a checklist describing the risk.

Notes that the agency's statement was not final, but used words like "would" and "could" for the proposed measures, said Mrs Hollrah, "there is progress, but we must follow closely. I can guarantee that we are here now and will be here in the future to ensure that this is followed up. We do not go away. "


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