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Health & FitLawsuit claims major breast implant maker knew its implants were likely causing cancer

20:55  29 august  2019
20:55  29 august  2019 Source:   msn.com

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.

Lawsuit claims major breast implant maker knew its implants were likely causing cancer© hxdbzxy/Shutterstock
  • On Aug. 16, two women filed a class-action lawsuit against major breast implant manufacturer Allergan.
  • In lawsuit documents obtained by Insider, lawyers on the case said Allergan filed negative reports about their implants under fake manufacturer names like "Costa Rica" and "Santa Barbra" to hide them.
  • The lawsuit comes after Allergan's Biocell breast implants were linked to a rare form of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
  • Allergan voluntarily recalled the implants in July at the request of the Food and Drug Administration.
  • The women who filed the lawsuit said they wouldn't have gotten Biocell implants if they knew about the cancer link. Neither of the women have BIA-ALCL.

On Aug. 16, two women filed a class-action lawsuit against major breast implant manufacturer Allergan after the company recalled its Biocell textured implants. The implants had been linked to a rare form of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.

Doctors, patients warn about cancer linked to textured breast implants

Doctors, patients warn about cancer linked to textured breast implants Experts believe there's an interaction between a woman's body and the 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. Dr. Elisabeth Potter, a plastic surgeon specializing in breast reconstruction in Austin, Texas, said she's heard from hundreds of women in the past three months who want their textured implants removed.

The women involved in the lawsuit are seeking monetary damages for themselves and other women with the implants because they "will be forced to expend substantial sums for the removal of the recalled implants, surgical and diagnostic fees, and/or medical monitoring and invasive diagnostic procedures required as a result of their exposure to the risk of contracting BIA-ALCL," according to lawsuit documents obtained by Insider.

As of September 2018, the FDA had received 457 unique reports of BIA-ALCL, including nine deaths "which may be attributable" to the cancer, according to a letter the FDA wrote to healthcare providers.

FDA to request recall of Allergan textured breast implants linked to cancer

FDA to request recall of Allergan textured breast implants linked to cancer There have been more than 500 cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) worldwide linked to textured breast implants.

According to the lawsuit, Allergan also used fake names like "Costa Rica" and "Santa Barbra" instead of "Allergan" to hide the exact number of negative effects reports that people filed. The lawyers working on the lawsuit said these false reports violate the law and also put anyone with the Biocell textured implants at risk of misinformation.

"As a result, consumers, health care professionals, and the FDA were unable to detect trends in Allergan's products, depriving the market of the necessary information to make an informed decision about whether Allergan's products were safe and effective," the lawsuit said.

Allergan has not responded to Insider's request for comment.


    Read More

    FDA wants stronger warning on breast implants about risks .
    U.S. health officials want women getting breast implants to receive stronger warnings and more details about the possible risks and complications. © Provided by The Associated Press FILE - This Dec. 11, 2006 file photo shows a silicone gel breast implant in Irving, Texas. On Wednesday, Oct. 23, 2019, the U.S. Food and Drug Administration said that breast implant manufacturers should add a boxed warning — the most serious type — to information used to market and prepare patients for implants.

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