On July 24, 2019, the Food and Drug Administration issued a notice requesting that the pharmaceutical company Allergan recall their textured breast implants from the U.S. market. This statement was issued to help protect women from Breast Implant Associated Anaplastic Large Cell Lymphoma, commonly referred to as BIA-ALCL. The FDA has found that women who received these breast implants were at a significantly higher risk of developing BIA-ALCL cancer.
This requested recall from the FDA in the United States follows that of 38 other countries who have already recalled Allergan’s products. Initial concerns of the safety of Allergan textured breast implants had began in 2017, in which the FDA did not issue a recall citing that they needed time to further study the issue.
The FDA then issued a report in July of 2019 that of 573 cases of BIA-ALCL in the world, 481 of them had been linked to Allergan textured breast implants. 84 percent of the world’s known cases of BIA-ALCL are linked to these implants.
Following the FDA’s request, in July 2019 Allergan noted that they would recall their BIOCELL textured breast implant products which include:
Additionally, the company has also recalled several of their tissue expanders.
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) is a rare form of non-Hodgkin’s lymphoma. While BIA-ALCL develops around textured breast implant or expanders, it is not breast cancer and can occur in many different parts of the body, including the lymph nodes and skin. It can take up to 10 years after a textured implant has been placed for BIA-ALCL to develop although cases have been confirmed in as little as two years and as long as 30 years after breast augmentation, with the median diagnosis being around 8 years.
Evidence suggests that patients are experiencing an allergic reaction to textured devices. Textured breast implants were promoted as a means to encourage tissue growth into the rough surface and aid in anchoring the implant. This textured surface may aid in bacteria clinging to the implant, resulting in an immune response leading to persist inflammation. Another consideration is that the surface of the textured implant may be abrasive or irritating, resulting in a prolonged inflammatory response or immune reactions.
Although textured breast implants are less commonly used in the US, the Allergan manufactured macro-textured implant still represent approximately 5% of all breast implants sold in the United States alone. Findings are suggesting that the textured variety of implant have resulted in BIA-ALCL significantly more often over smooth implants, however BIA-ALCL has been diagnosed in a small number of patients who received smooth implant recipients as well.
BIA-ALCL has been found to manifest in the scar tissue and fluids around breast implants. In some cases, the cancer can spread to other parts of the body, but typically remains concentrated around breast implants. Symptoms of BIA-ALCL can take up to 10 years to manifest.
BIA-ALCL symptoms include the following:
For individuals who have received a diagnosis of BIA-ALCL, the FDA currently suggests that these patients undergo implant removal surgery to remove the breast implants as well as the scar tissue located around the implants. As this is an extensive operation, the FDA does not recommend this surgery for individuals not showing the symptoms of BIA-ALCL with Allergan textured breast implants.
As noted above, current recommendations from the FDA do not support removing textured implants in women who aren’t displaying symptoms of BIA-ALCL. Instead, they’re urging women to educate themselves on the symptoms of BIA-ALCL and monitor the area around the breast implants for any changes or new symptoms. If you notice any symptoms or changes, it is recommended to contact your physician immediately.
Allergan textured breast implants were recalled in 38 countries, and Allergan continued to sell their implants in the United States prior to being recalled by the Food and Drug Administration in July of 2019. The full impact caused by Allergan’s breast implants will not be known for several years.
If you have received an Allergan textured breast implant and have been diagnosed with BIA-ALCL we urge you to contact our office to speak with an attorney. At the Kagan Law Firm, we specialize in defective medical drug and device cases and welcome the opportunity to help you recover compensation for injuries and damages incurred as a result of receiving textured breast implants. For a free consultation, please contact our office directly at (239) 466-1161.
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