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Allergan™ Breast Implant Issues

Allergan, the manufacturer of a popular breast implant, announced a recall of their Biocell textured breast implant in July of 2019. This was done in response to an FDA determination that nearly all cases of Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA-ALCL) have been linked directly to the Allergan Biocell implant. The FDA requested a Class I recall advising that women with Allergan Biocell textured implants have approximately a 600% increased risk of developing BIA-ALCL then with other textured implants.

 

BIA-ALCL is a type of non-Hodgkin lymphoma (a cancer that affects the immune system) that may develop many months or years after a breast implant procedure. It is not a cancer of the breast tissue. BIA-ALCL usually presents as an accumulation of fluid (known as seroma fluid) between the implant and the surrounding tissue. While the cause is idiopathic in nature, possible risk factors and causes for the disease include the high surface area of the implants, genetic factors, and long-term (chronic) inflammation around the implant triggered by factors such as bacteria around the implant.

 

According to data released by the FDA, at least 573 known cases of ALCL have been diagnosed worldwide, included in that number are at least 33 deaths which have also come as a result of this rare form of cancer. Of those 573 cases, 481 have been linked to breast implants sold by Allergan. There have only been 13 deaths where the manufacturer was of the implant was known, 12 of those were produced by Allergan. ALCL is an extremely rare form of cancer, it is not widely tested for. As such, the number of potentially injured parties is likely a significant multiple of the known sphere of claimants.

Current Status Of Litigation

In December 2019 the US Judicial Panel of Multidistrict Litigation (JPML) ordered the consolidation of claims, MDL #2921, to be transferred to the U.S. District Court of New Jersey, where they will be centralized under the supervision of Judge Brian R Martinotti. Judge Martinotti most recently presided over the Invokana MDL #2750. There are currently just over 600 ALCL related lawsuits that have been filed into the MDL.

Important Links:

  1. https://www.fda.gov/medical-devices/medical-device-recalls/allergan-recalls-natrelle-biocell-textured-breast-implants-due-risk-bia-alcl-cancer
  2. https://www.fda.gov/medical-devices/breast-implants/medical-device-reports-breast-implant-associated-anaplastic-large-cell-lymphoma

MDL Links:

  1. https://www.njd.uscourts.gov/allergan-biocell-textured-breast-implant-products-liability-litigation
  2. https://www.njd.uscourts.gov/invokana-litigation