Individuals typically undergo breast implant surgery for purposes of either augmentation or reconstruction. Breast augmentation involves the procedure of enlarging a female’s breast size for cosmetic purposes. Breast reconstruction involves the replacement of breast tissue that has been removed via mastectomy or other medical procedure that is performed due to cancer, trauma, or other medical condition.
Tissue expanders are also used in breast implantation procedures. These devices are used following a mastectomy, treatment for undeveloped breasts, and treatment of soft tissue deformities. These expanders are intended to be for temporary use only, ideally to be under the skin or muscle for less than six months.
Allergan BIOCELL Recall
In July 2019, the U.S. Food and Drug Administration (FDA) issued a Class I recall of Allergan® BIOCELL textured breast implants. The FDA’s recall follows the December 2018 suspension of BIOCELL sales in the European Union, Australia, Brazil and Israel—as well as a May 2019 suspension in Canada. These actions are a result of reports that show a significant link between Allergan’s BIOCELL textured implants and the risk of developing Breast Implant-Associated Anapestic Large Cell Lymphoma (BIA-ALCL)—a rare type of cancer.
A Class I recall is defined as a “situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.” Textured implants have been under scrutiny for causing health complications in the past. However, studies have found that individuals with Allergan’s BIOCELL implants are at least six times more likely to develop BIA-ALCL than those with other types of breast implants.
The Class I recall issued by the FDA requests the recall of all Allergan BIOCELL textured breast implants and expanders. These products include:
- Allergan Natrelle BIOCELL Textured Products:
- Allergen Natrelle Saline- Filled Textured Breast Implants
- Allergen Natrelle Silicone- Filled Textured Breast Implants
- Allergen Natrelle 410 Highly Cohesive Anatomically Shaped Silicone- Filled Textured Breast Implants
- Allergen Natrelle 133 Plus Tissue Expander
- Allergen Natrelle 133 Tissue Expander with Suture Tabs
- Lot numbers: all lots
- Manufacturing Dates: July 25, 2014- June 21, 2019
- Distribution Dates: September 14, 2014- July 24, 2019
- Devices Recalled in the U.S.: 246,381
- Date Initiated by Firm: July 24, 2019
Because no information has been released as to the minimum duration of exposure necessary to heighten the risk of developing BIA-ALCL, Allergan Natrelle 133 and 133 Plus have been included in the FDA recall as a precaution.
The FDA recall came shortly after 38 countries had already recalled Allergan’s products. Worldwide, at least 573 cases of BIA-ALCL have been reported, including 33 deaths attributed to the implants. Out of these cases, 481 cases and 12 fatalities involved individuals with Allergan BIOCELL implants. In the United States alone, hundreds of thousands of patients are estimated to be at risk for adverse reactions to the BIOCELL implants.
How Can You Protect Yourself?
The FDA is not currently recommending the removal of recalled breast implants unless patients are experiencing signs or symptoms of BIA-ALCL. Methods for reducing the risk of developing BIA-ALCL include breast reconstruction, augmentation, using alternative breast implants, and/or considering autologous tissue.
It is critical for patients who have Allergan BIOCELL implants, but have thankfully not yet experienced adverse side effects, to nevertheless continue to monitor their health. It is believed that there is a latency of seven to ten years after the placement of these implants for an individual to demonstrate symptoms of BIA-ALCL. Anyone within the “at-risk” window should continue to diligently monitor their symptoms, which may include:
– Abnormal swelling around the breast area
– Abnormal mass
– Pain and discomfort
– Rashes or itchiness around the breasts
– Changes in the shape or size of the breasts
Patients who do notice symptoms of BIA-ALCL should speak with their health care provider immediately.
If you have undergone breast augmentation with the Allergan BIOCELL breast implant product line, make sure to retain your records of the device manufacturer, unique device identifier and implant model name; this information is crucial to provide to your physician in the event a health problem arises to timely diagnose BIA-ALCL or other health condition.
Slater Slater Schulman LLP is currently evaluating potential Allergan BIOCELL breast implant claims. If you’ve been diagnosed with BIA-ALCL or another form of cancer after exposure to the Allergan BIOCELL breast implants, the attorneys at Slater Slater Schulman LLP are here to help. Please call our office at 1-800-251-6990, or fill out the form below, and our office will contact you to discuss your case.