Deaths From Breast Implant-Linked Cancer: FDA

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Now, after years of studying the issue, the U.S. Food and Drug Administration says there appears to be a connection between breast implants and a rare form of cancer that has claimed at least nine lives. It is called breast implant-associated anaplastic large cell lymphoma and mostly occurs in a capsule of tissue that develops around the implant.

The FDA released an update on Tuesday about its understanding of breast implant-associated ALCL cases and citing the possible risks of this form of cancer in women with breast implants. This specific form of cancer is typically treatable and not fatal, and is most likely to occurred with textured implants (that have "a pebbly surface") than with smooth implants, the FDA said.

The cancer was first linked to breast implants in 2011. As the FDA notes, it medical device reports can't answer that question, because they don't represent all cases, and the denominator-the total number of women who've received breast implants-isn't known. The cases seem to occur more often in patients with textured surfaces on the implants, and are associated with pain and swelling that may occur years after the surgery has healed. Of those, 203 were textured implants and 28 involved smooth implants. Most cases of ALCL have been treated by removing the breast implant.

"There's many kinds of texturing, and different companies do it differently", Srinivasa says, so it's hard to know what specific quality of textured implants could be associated with the cancer.

The FDA has a breast implants website with more details.

In its statment, the FDA said it will "continue to collect and evaluate information about ALCL in women with breast implants" on an "ongoing basis".

Since then, doctors registered with the British Association of Aesthetic and Plastic Surgeons BAAPS, who represent all cosmetic surgeons working in the NHS, have warned patients of BIA-ALCL.

Since 2011, packaging for all implants sold in the US and Canada has listed the possible cancer risk, and advises women to discuss all the risks and options with their doctor.

The FDA is urging women debating whether to get implants to educate themselves about them before agreeing to surgery.

"If you already have breast implants, there is no need to change your routine medical care and follow-up", the FDA statement said.

Nevertheless, a ruptured silicone implant is more hard to detect, since its contents remain in place - unlike the saline implant, which simply deflates, making the rupture very noticeable.

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