October 16, 2019 - What Are the Issues Associated with Allergan Breast Implants Cancer? This past July, the FDA asked Allergan to recall certain textured breast implants and tissue expanders (BIOCELL and Natrelle Inspira). A full list of the recalled Allergan textured breast implants can be found at https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue. The requested recall was intended to protect consumers from an increased risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which is a form of non-Hodgkin’s lymphoma. Cases of BIA-ALCL have been submitted across the globe, with many of them tied to the textured breast implants.
The texture of the recalled implants is unique to Allergan. More than 500 cases of BIA-ALCL have been linked to the textured breast implants, and twelve deaths are directly attributed to the recalled Allergan textured breast implants. The FDA has determined that women with a BIOCELL or Natrelle Inspira recalled textured breast implant have a risk of BIA-ALCL which is six times that of women with implants from other manufacturers.
BIA-ALCL is a cancer of the immune system. When fluids and scar tissue build up around a textured breast implant, BIA-ALCL can develop. While the cancer is usually contained to the scar tissue and fluids, it can spread to the lymph nodes, and even throughout the body. A diagnosis of BIA-ALCL can be very serious. While most women diagnosed with BIA-ALCL will have the recalled implants removed, some will require radiation and/or chemotherapy.
When the disease is not diagnosed and treated early, death can occur. The symptoms associated with BIA-ALCL include:
- Excessive fluid buildup around the implant;
- Pain surrounding the implant;
- Swelling surrounding the implant;
- Breast enlargement;
- Overlying skin rash;
- Hardening of the breast;
- Lumps in the breast, or
- Lumps in the armpit.
Smooth-surface breast implants are more traditionally used during cosmetic breast surgery procedures, while textured-surface implants are more likely to be used following a mastectomy, during a reconstructive process—although this is not always the case. In some instances, the textured breast implants have been used in cosmetic procedures, and among the more than 500 women who have developed BIA-ALCL from a textured breast implant, the numbers are almost evenly divided between cosmetic and reconstructive.
How is BIA-ALCL Diagnosed? As BIA-ALCL progresses, cancerous cells enter the capsule—the natural covering the body builds around any foreign object, in an attempt to protect surrounding tissues. Once the cancerous cells enter this capsule, they are more likely to invade other tissues, including the lymph nodes. Women with textured breast implants should have annual breast wellness checks. If a woman has any symptoms of BIA-ALCL, she should have the fluid surrounding the implant checked.
Should You Consider an Allergan Textured Breast Implant Lawsuit? Two women recently filed a class-action lawsuit against Allergan, a major manufacturer of breast implants, and the subject of the FDA recall. The Allergan breast implant lawsuit concerns the link between the recalled Allergan textured breast implants and BIA-ALCL. The women who filed the class-action lawsuit against Allergan have stated that had they known of the potential cancer risk from the Allergan textured breast implants, they would have chosen a different type of implant.
Allergan has agreed to cover the costs for new implants for women who currently have a recalled Allergan textured breast implant, replacing the textured implant with a smooth implant. The corporation has, however, refused to cover the surgical costs for removal and replacement. This program will run from now until July 24, 2021. If you have experienced problems with your Allergan textured breast implants, it could be beneficial to speak to an experienced breast implant lawyer.
We can review the facts of your potential claim, including whether you have developed BIA-ALCL, and whether the disease was caused by your recalled Allergan textured breast implants. You deserve help during this difficult time, and we can answer all your questions regarding whether a textured breast implant lawsuit is right for you.