FDA requests Allergan voluntarily recall its Allergan textured breast implants linked to rare lymphoma cancer.
On July 24, 2019, the U.S. Food and Drug Administration (FDA) requested that the medical device manufacturer Allergan voluntarily recall its BIOCELL textured breast implants and tissue expanders. The recall request was initiated “to protect individuals from the increased risk of breast-implant associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants.”
Allergan plc, is a Dublin, Ireland-based manufacturer of medical device products used world-wide. Allergan plc is listed on the New York Stock Exchange (NYSE: AGN).
The FDA’s recall notice is here:
The FDA noted in its recall in the United States that newly-submitted Medical Device Reports (MDRs) worldwide reported a total of 573 unique BIA-ALCL cases, including 33 patient deaths. Of the 573 cases of BIA-ALCL, the FDA found that 481 were reported to have Allergan textured breast implants at the time of diagnosis, with more implant deaths possible. The Washington Post reported on July 24, 2019, that the FDA’s director of Center for Devices and Radiologic Health determined to remove these devices from the market “after seeing the sharp increases in reported deaths.”
The Washington Post article:
According to the Wall Street Journal, reporting on the recall on July 24, 2019, “hundreds of thousands of women have received the recalled Allergan implants.” In a conference call with reporters on July 24, 2019, the Wall Street Journal reported that “Amy Abernathy, the FDA’s principal deputy commissioner, said … ‘We know that today’s news will be alarming to patients with breast implants.’”
The Wall Street Journal article:
As stated in its July 24, 2019, recall notice, the FDA reported the following:
Based on the currently available information, including the newly submitted data, our [FDA] analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Alergan’s Biocell BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL. [Emphasis added].
The FDA points out in its notice that BIA-ALCL is not breast cancer. It is a type of non-Hodgkin’s lymphoma, which is a cancer of the immune system. The FDA states that “in most cases, BIA-ALCL is found in the scar tissue and fluid near the implant, but in some cases, it can spread throughout the body.”
According to the FDA, symptoms of BIA-ALCL are primarily persistent swelling or pain near the breast implant. Implant recipients are urged by the FDA to monitor the area around the breast implants for any changes.
The FDA’s voluntary recall notice has posted a list of recommendations for those who may have had these particular breast implants surgically placed, including a list of offending models subject to the voluntary recall.
Primary among those recommendations is to immediately talk to your healthcare provider. Health care providers are recommended to “immediately stop using (implanting) Allergan BIOCELL breast implants.”
Allergan plc has agreed to cooperate with the FDA’s request, and announced a voluntary recall of “BIOCELL Textured Breast Implants and Tissue Expanders.” See its press release from Allergan’s website here:
WHAT TO DO NEXT AND WHY CHOOSE JAMES T. SNYDER LAW?
If you or someone you know in New York State has been injured by or died from BIA-ALCL associated with Allergan BIOCELL textured implants, you and/or the deceased’s estate may be entitled to compensation. But if you’ve seen ads on TV or are searching the internet for an attorney to help -- you may be bewildered or confused by all the Google search results, 800 numbers, faceless law firms, etc.
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So for a free, no-obligation personal consultation about your legal rights or those of a deceased in New York regarding Allergan implants, call me at 315-884-8888 or fill out the easy-to-complete form on my Allergan website link: https://www.jimsnyderlaw.com/allergan-biocell-textured-breast-implants
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