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FDA Recalls Allergan Biocell Textured Implants

Allergan

In 2019, the FDA recalled Allergan Biocell Textured implants. This was done because of the advanced likelihood and probability of the implant being linked to ALCL cancer. Anaplastic large cell lymphoma (BIA-ALCL) is a type of non-Hodgkins lymphoma, which is cancer of the immune system.

JPML Actions

In late 2019, the Judicial Panel for Multidistrict Litigation allowed for the consolidation of Allergan BioCell breast implant cases.

Legal Waiver

Some clients may have been given a legal waiver to sign by their primary care physician, or by their surgeon. If signed, the consent forms act as a deterrent for lawsuits against Allergan. It will appear to be regular paperwork, however, is actually a concern for alleviating liability.

Recalled Implants

  • The recalled Allergan textured breast implant by the FDA included:
  • Allergan Natrelle Saline-Filled Breast Implants
  • Allergan Natrelle Silicone-Filled Textured Breast Implants
  • Allergan Natrelle 140 Highly Cohesive Anatomically Shaped Silicone Filled Breast Implants.

Causation

There are four overlapping theories as to current causation from the textured breast implants: the particles on the implant and generated by the implant create enormous amounts of friction with the underlying tissue; interaction of the surface on the surface of the tissue; hydrocarbons in the silicone elastomer and particles; and biofilms.

Science

The science currently supports that BIA-ALCL is caused by inflammation. BIA-ALCL is related to the textured breast implants because there are no cases of a LCL with a confirmed history of smooth only implants and expanders. Finally, some textures are worse than others. Allergan’s BioCell texture implants are associated with many more cases than any other textured implant.

Michael Brady Lynch Firm

Here at the Michael Brady Lynch Firm, we specialize in handling multidistrict litigation claims such as these. Please give us a call at 888-585-5970 or email us at brandon@mblynchfirm.com.

 

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