Allergan, a major breast implant manufacturer, issued a worldwide recall on its textured implants in light of recent studies tying the implants to a rare form of cancer. The July 24 recall came shortly after the FDA asked the company to take its textured implant devices off the shelves.
Recent studies by the FDA have corroborated the link between BIA-ALCL, a lymphatic cancer, and textured breast implants. Allergan, one of the leading breast implant manufacturers, already faces multiple lawsuits by victims of BIA-ALCL and their families.
Lymphoma risk verified amidst pending litigation
Breast-implanted associated anaplastic large cell lymphoma–or BIA-ALCL–is a rare form of cancer specifically found women with breast implants. Although the disease develops in the breast, it isn’t a form of breast cancer. Rather, it’s a cancer of the immune system’s lymphocyte cells. If not caught quickly enough, the cancer will spread to the lymph nodes.
The exact cause of BIA-ALCL, and its connection to textured breast implants, is currently under investigation. However, it is thought that the textured implant surfaces irritates internal tissue, causing scar tissue to form around the breast. The scar tissue then develops cancer cells, which attack the body’s lymphocytes.
Allergan is also facing a class-action suit from its investors, who claim that the company concealed the link between its textured implants and BIA-ALCL. The complaint alleges that this link, and Allergan’s resulting market restrictions, irreparably damaged company stock prices.
BIA-ALCL incidents on the rise
In a recently updated table, the FDA reported 573 total cases–and 33 deaths–of BIA-ALCL globally. Compared to the table published just five months ago, these figures show a staggering increase of 116 additional BIA-ALCL cases and 24 deaths since February. It is not yet known whether this increase is due to more frequent diagnoses or an increase in overall cases.
The FDA determined the implant manufacturer in 13 out of the 33 fatal BIA-ALCL cases. The agency found that Allergan manufactured 12 of the 13 fatal breast implants.
Types of implants at risk
Although smooth implants are tied to a few BIA-ALCL cases, textured implants are the main culprit. The FDA’s research showed that only 5% of reported cases involved smooth implants, while 67% involved textured ones. In 28% of reported cases, the implant texture was unknown. In its recall request, the FDA specifically asked Allergan to recall only its textured implant devices.
According to the FDA’s research, the implant’s filling has no bearing on the likelihood of lymphoma development. At present, however, more BIA-ALCL cases are tied to silicone implants, as opposed to saline.
Luckily, textured implants make up only about 5% of the implants sold in the United States. The FDA stated that women with textured implants who do not have any BIA-ALCL symptoms should not undergo the risk of surgical removal.
The agency emphasized that the “overall incidence of BIA-ALCL appears to be relatively low.” However, the sharp increase in diagnoses and deaths since February suggests that the BIA-ALCL problem is far from over. FDA spokesman Jeff Shuren stated that the agency will “continually evaluate any new information and may, as a result, take action regarding other breast implants, if warranted.”
If you or a loved one has suffered a cancer diagnosis after receiving textured breast implants, call the Tennessee breast implant attorneys at David Randolph Smith & Associates.