FDA requests that manufacturer recall implants linked to cancer

On Behalf of | Aug 1, 2019 | General Litigation |

Women in Georgia who are considering breast implants, or have had them in the past, should pay attention to the recent news that studies have linked a particular brand of textured breast implants to a rare form of cancer. Due to the evidence that appears to link the specific product to patient harm, the Food and Drug Administration requested that the manufacturer of the implants recall them. Allergan, the company responsible for the manufacture of the implants, complied with this request last week, issuing a statement saying that no further distribution or sale of the implants in question will take place. 

At issue are Allergan’s textured breast implants sold under the brand name BIOCELL. Textured implant use in the United States is less common than in Asia or Europe, and it is unclear at this time to what extent, if any, the texturing contributes to increased cancer risk. Nevertheless, the FDA reports that the risk of developing a particular type of anaplastic large cell lymphoma associated with breast implants is six times greater in patients with Allergan BIOCELL implants than with textured implants from any other manufacturer. 

The recall affects BIOCELL implants and tissue expanders filled with either silicone or saline. The FDA is providing additional information to providers and patients who have already received BIOCELL implants for further consideration. However, it does not recommend the voluntary removal of the implants in the absence of problems or symptoms. 

The incidence of breast implant-associated ALCL appears to be relatively low. On a global scale, the FDA has thus far identified 573 cases. Of those, however, 481 patients reportedly received Allergan implants. That figure equates to approximately 12 out of 13 of the patients for whom breast implant manufacturer information was verifiable. 

Patients who come to harm as a result of a surgical implant may have grounds to seek legal damages. It may be helpful to contact an attorney to see if the case qualifies.