Breast implant manufacturer Allergan instituted a worldwide recall of its textured implants in July of 2019. The Food and Drug Administration (FDA) classified the recall as a Class I, meaning it was the most serious type of recall and that the product may cause serious injuries or death. Studies tied the breast implants to a rare form of cancer.
Types of Implants Involved in the Recall
Breast implants are used in both breast augmentation surgery and in breast reconstruction surgery. There a number of different types of breast implants, and those that are involved in the recall are known as textured implants as opposed to smooth implants. FDA research found that 67% of reported cancer cases involved textured breast implants. The implants that are specifically involved in the recall include:
- Allergan Natrelle Saline-filled Textured Breast Implants
- Allergan Natrelle Silicone-filled Textured Breast Implants
- Allergan Natrelle 410 Highly Cohesive Naturally Shaped Silicone-filled Textured Breast Implants
- Allergan Natrelle 133 Plus Tissue Expander
- Allergan Natrelle 133 Tissue Expander With Suture Tabs
Fortunately, textured implants make up only 5% of the breast implant market. However, for those women who have used these implants, it has become a serious risk.
Studies found the use of textured implants resulted in an increased risk of developing a rare form of cancer associated specifically with the use of breast implants. The cancer is called breast-implant associated anaplastic large cell lymphoma or BIA-ALCL. This cancer develops in the breast but is not a form of breast cancer. It’s a cancer of the immune system’s lymphocyte cells. If this cancer is not caught early, it can spread to the lymph nodes. The exact connection between BIA-ALCL and textured breast implants is still under investigation. It is believed, however, that the textured implant surfaces irritate the tissue surrounding the breast, causing scar tissue that develops into cancer cells. These cancer cells then attack the body’s lymphocytes. This risk is especially heartbreaking for women who have received these implants as part of reconstructive surgery after surviving breast cancer.
According to the FDA, the recall does not mean that all women must have their implants removed. The FDA says the surgery is not worth the risk if the woman is not showing symptoms. Symptoms of BIA-ALCL include lumps, pain, swelling, and asymmetry of the breasts.
Several lawsuits have been filed against Allergan across the country. The lawsuits allege that Allergan was aware of the link between cancer and textured breast implants and failed to warn the public. There has been an increase in incidents of BIA-ALCL, and it is possible that more implants will be implicated in causing cancer. There may be more breast implant recalls down the line as the FDA looks into this further.
Contact an Experienced Product Liability Attorney
If you’ve developed BIA-ALCL as the result of textured breast implants, you should have an experienced product liability attorney evaluate your case. Gregg Goldfarb has over 20 years of experience helping those who’ve been injured by defective products. Contact us online or call us at 305-374-7000 to schedule a free consultation.