CNN reported on July 25, 2019, that Allergan “issued a worldwide recall of Biocell textured breast implants and tissue expanders that have been linked to a rare cancer. The move came after the US Food and Drug Administration requested the manufacturer voluntarily recall the products.” Allergan claimed the recall was in response to global information that showed concerns about patients developing breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL.
The FDA, according to the CNN report, acknowledges that textured breast implants are more commonly used outside the United States than in this country. The US market represents less than five percent of the “macro-textured implant” marked. Still, the FDA believes that hundreds of thousands of women have the implants subject to the recall.
The recalled breast implants include:
- Natrelle Saline-Filled breast implants
- Natrelle Silicone-Filled breast implants
- Natrelle Inspira Silicone-Filled breast implants
- Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants
The recalled tissue expanders include:
- Natrelle 133 Plus Tissue Expander
- Natrelle 133 Tissue Expander with Suture Tabs
FDA awareness of a possible link between breast implants and cancer
The alarm about breast implants causing BIA-ALCL dates back to 2011 when the FDA first announced a possible link.
Currently, the FDA isn’t recommending that women who have these types of breast implants seek removal of the implants if they don’t have BIA-ALCL symptoms. The FDA does advise women who have the implants to learn the symptoms of the disease and to continually monitor their breasts for any changes that could be associated with a defective implant. If changes are noticed, women should immediately speak with their physician.
The symptoms of BIA-ALCL include swelling and pain, and may take years to develop. So far, 573 cases of ALCL have been disclosed to the FDA, resulting in 33 deaths.
The FDA’s principal deputy commissioner of food and drugs said they notified Allergan of the link to physical harm and death. She says the FDA is monitoring the link to the deadly disease across other textured and smooth implants, tissue expanders, and other breast product. The FDA says it is examining whether the risk of developing the disease is limited to specific models or to all textured breast implants.
The FDA says it is considering clearer label warnings of the health risk.
The American Society of Plastic Surgeons says that breast augmentation is the most popular form of cosmetic surgery. The FDA says up to one in five women with a breast implant need to have it removed within 8 to 10 years of the initial implant surgery.
Companies who manufacture products that are defective can be held strictly liable if the defect causes death or harm. This includes makers of products such as breast implants if it can be shown that the implant was defective and that the defect caused cancer or any other physical disease or disorder.