What You Should Know:
- On July 24, 2019, the FDA requested that Allergan recall its BIOCELL textured breast implants and tissue expanders to protect individuals from the increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), associated with Allergan BIOCELL textured breast implants.
- BIA-ALCL is not breast cancer – it is a type of non-Hodgkin’s lymphoma (cancer of the immune system). 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.
- Lawsuits have been filed by women who developed BIA-ALCL from their implants.
- The lawsuits accuse the implant manufacturer of manufacturing, marketing and selling a product which it knew or should have known could cause cancer, yet did nothing to warn consumers.
- Contact Borgess Law, LLC at (567) 455-5955 for a free, confidential and no-obligation consultation if you believe you might have a potential claim.
The Recall
On July 24, 2019 the FDA began to take measures to protect women from BIA-ALCL, a type of non-Hodgkin’s lymphoma, by requesting that Allergan recall specific models of its textured breast implants from the market because they were linked to a higher cancer risk. The FDA has identified this as a Class I recall, the most serious type of recall where use of the recalled devices may cause serious injuries or death.
As of the date of the recall in July 2019, the FDA reported a total of 573 unique BIA-ALCL cases including 33 patient deaths. Of the 573 cases of BIA-ALCL, 481 were reported to have Allergan breast implants at the time of diagnosis. In addition, 12 of 13 deaths occurring in patients with BIA-ALCL where the manufacturer was known occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis. The manufacturer and/or texture was unknown for the remaining 20 reported deaths from BIA-ALCL.
Based on this information, the FDA stated that its analysis demonstrated 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 Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences and potentially death from BIA-ALCL.
A list of the recalled products is available on the FDA’s website.
What is a Textured Breast Implant?
Textured breast implants have an outer silicone rubber shell with a rough, pebbly, irregular surface almost like soft rubber sand paper. Textured breast implants develop scar tissue to stick to the implant, making them less likely to move around inside of the breast and become repositioned.
What is BIA-ALCL?
BIA-ALCL is a rare form of T-cell lymphoma that occurs in some people who have had breast implants. It is not breast cancer but rather is a cancer of the immune system. The lymphoma occurs in the scar tissue (fibrous capsule) that surrounds the implant and in more advanced cases may spread to lymph nodes that are near the breast.
Symptoms of BIA-ALCL?
According to the FDA, the main symptoms of BIA-ALCL are persistent swelling, presence of a mass or pain in the area of the breast implant. These symptoms may occur well after the surgical incision has healed, often years after implant placement.
Upon evaluation by a health care provider, evidence of fluid collection around the breast implant (seroma) is often observed. Some patient reports indicated that a lump under the skin or capsular contracture (thick and noticeable scar capsule around the implant) were present.
Status of Litigation:
Recently, the Judicial Panel on Multidistrict Litigation (JPML) created a new MDL for federal lawsuits for women who developed BIA-ALCL from their implants. The lawsuits allege Allergan’s textured breast implants and tissue expanders significantly increase the risk of developing BIA-ALCL and that Allergan failed to warn the FDA, patients and healthcare providers of this risk.
In the 12/18/19 order, the JPML ordered the transfer of the cases to the U.S. District of New Jersey before Honorable Judge Brian Martinotti for coordinated pretrial proceedings. (An MDL is a type of legal proceeding that helps federal courts efficiently manage many similar cases filed in many different federal courts across the U.S. by allowing the temporary transfer of all of the federal civil lawsuits to one or more district courts for pretrial consolidation or coordination. The JPML is a group of federal judges designated by the Chief Justice of the United States, which has the responsibility for determining which cases qualify for MDL treatment, as well as which district court to transfer and consolidate these cases. The transfers are made if the Panel determines that the transfers will result in the convenience of the parties and witnesses and will promote the just and efficient conduct of the cases. For more information about MDLs and the JPML, contact Borgess Law.)
How we can help if you believe you may have a legal claim:
Borgess Law, LLC is currently reviewing potential legal claims for individuals who have been diagnosed with BIA-ALCL after having received an Allergan Biocell® textured breast implant. There is no charge for this review.
Attorney Pamela A. Borgess, the founder of Borgess Law, LLC, has extensive experience with numerous national high-profile defective medical drug/device cases and can discuss your legal options. For more information about the Allergan Breast Implant litigation or to discuss a potential claim, contact Borgess Law at (567) 455-5955. You can also contact Borgess Law by submitting an online inquiry. Again, this consultation is free and confidential. We welcome any questions you may have.
*This blog does not contain medical advice and is not intended to substitute for professional medical advice, diagnosis or treatment. Please consult with your physician for personalized medical advice.