Allergan’s Natrelle BIOCELL Textured Surface Implants Recall

Attorney Richard Martin by Richard M. Martin, Jr.

In January 2011, the FDA identified a link between Allergan’s Natrelle Biocell textured surface breast implants and “breast implant associated anaplastic large cell lymphoma” (“BIA- ALCL”). BIA-ALCL is a type of non-Hodgkin’s lymphoma, a cancer of the immune system.

BIA-ALCL is not breast cancer, although in most cases, BIA-ALCL is found in the scar tissue and fluid near the breast implant. In some cases, BIA-ALCL cancer will spread throughout the body to other systems.

The main symptoms of BIA-ALCL are persistent swelling or enlargement of a patient’s breast or surrounding tissue that develops a year or more after breast implant surgery, lumps in the breast or armpit, pain, rash, redness, hardening of the breast, or changes in the shape or size of the breast.

BIA-ALCL is a serious cancer and can be fatal, especially if not diagnosed early or promptly treated. BIA-ALCL can be treated by surgically removing the implant and surrounding scar tissue. Some patients may also require chemotherapy and radiation treatments.

The symptoms of BIA-ALCL may occur years after the implant placement. The diagnostic testing recommended to determine if BIA-ALCL is present is invasive.

On July 24, 2019, the FDA issued a worldwide Class I Recall of Allergan’s Natrelle BIOCELL textured surface implants. A Class I Recall is the most series type of recall and indicates that use of the recalled product may cause serious injury or death.

The FDA issued this recall because Allergan’s Natrelle BIOCELL textured surface implants were tied to a large majority of cases of BIA-ALCL cancer and BIA-ALCL cancer-related deaths.

Immediately afterward, Allergan announced a “voluntary” recall of these breast implants, and many women received a letter from Allergan advising of the recall. This letter, which mentions BIA-ALCL cancer, started the statute of limitations clock which is running against its recipients (women with the breast implants) and in favor of Allergan.

A statute of limitations is the legal deadline before which you must file suit. If the legal deadline passes, you lose your right of action to file suit. Louisiana has a one-year statute of limitations. Generally, the one-year time period begins when you knew or should have known about the link between BIOCELL implants and BIA-ALCL cancer. The question to ask is when you became aware of a connection between the BIOCELL implants and BIA-ALCL cancer.

Filing suit will always be timely if done before the first anniversary of the FDA’s July 24, 2019 recall, meaning file suit on or before Wednesday, July 23, 2020. If you did not get a letter from Allergan, this is the safest course of action.

Some women with BIOCELL textured surface implants were unaware of the FDA’s July 24, 2019 recall but shortly thereafter received letters from Allergan noting the recall. These letters appear to be dated August 9, 2019 but this may not be the case with every letter. So, if you received a letter, the absolute last day on which to file suit is the last day before the first anniversary of the date on your letter.

In an abundance of caution, we urge all women with BIOCELL textured surface implants to file suit on or before Wednesday, July 23, 2020. If you or a loved one has experienced a defective Allergan breast implant, please contact us today for a free consultation.

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