Health & FitFDA to request recall of Allergan textured breast implants linked to cancer

17:26  24 july  2019
17:26  24 july  2019 Source:   nbcnews.com

Breast implants tied to rare cancer to remain on U.S. market

Breast implants tied to rare cancer to remain on U.S. market FDA says its risks do not warrant a national ban. require(["medianetNativeAdOnArticle"], function (medianetNativeAdOnArticle) { medianetNativeAdOnArticle.getMedianetNativeAds(true); }); But the Food and Drug Administration said Thursday it is considering bold warnings for the implants and requiring stricter reporting of problems by manufacturers. The announcement is the latest in the government's decades-long effort to manage implant risks and complications that can include scarring, pain, swelling and rupture.

Breast implants made by Allergan that have been linked to an uncommon form of cancer are being taken off the market in Europe, French authorities The company had applied for renewal, but French health officials requested additional data on the textured implants , which the company said it could

Breast implants that have been linked to a rare form of cancer have been pulled from the market in Europe. The recall of Allergan textured implants , one of the most popular types in the UK, came after French authorities announced they had withdrawn approval for their sale in Europe.

In a major reversal, the Food and Drug Administration announced today they are asking breast implant maker Allergan to recall its textured implants after the agency found a higher risk of cancer linked to those devices.

FDA to request recall of Allergan textured breast implants linked to cancer© yacobchuk/Getty Images

The move comes after 38 countries already banned the implant because of the higher risk of breast implant associated-anaplastic large cell lymphoma, or BIA-ALCL, a cancer of the immune system.

"Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer's product appeared to be directly linked to significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women's health," said FDA principal deputy commissioner Dr. Amy Abernethy in a statement.

Breast implants linked to rare form of cancer, but FDA declines to ban

Breast implants linked to rare form of cancer, but FDA declines to ban Recent medical studies have found that anaplastic large cell lymphoma (BIA-ALCL) which is a rare type of non-Hodgkin lymphoma, is notably higher in patients who have textured implants, compared to other types. The majority of women in the U.S. get “smooth surface” implants rather than textured, and to-date there has been no connection found between smooth and the BIA-ALCL. require(["medianetNativeAdOnArticle"], function (medianetNativeAdOnArticle) { medianetNativeAdOnArticle.getMedianetNativeAds(true); }); “It is not a massive pandemic, but it is real,” Dr.

More cases of breast implant -associated cancer were found by the FDA . The majority of ALCL cases have been linked to the textured devices. In December, France’s National Agency for the Safety of Medicines and Health Products (ANSM) asked Allergan to recall its textured implants after the

A type of breast implant linked to a rare form of cancer will remain on the market, according to U.S Meanwhile, Health Canada recently banned textured implants – a move embraced by breast cancer survivors who expressed Allergan to recall textured breast implants in canada.

The FDA today also updated the number of cases to date. Worldwide, there is now a total of 573 cases. 33 women have died.

Last November, NBC News, along with its partner the International Consortium of Investigative Journalists, found that BIA-ALCL is an emerging risk for women with textured implants.

In March, the FDA said BIA-ALCL is most likely caused by textured breast implants, which have a suede-like coating. But the agency stopped short of taking the implants off the market, noting it wanted to continue studying the disease and tracking cases. It's estimated that of the 400,000 women who get breast implants each year, about one in 10 has textured implants.

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