Much of the initial concern over textured breast implant associated cases of anaplastic large cell lymphoma started out focused on non-U.S. markets. While the vast majority of U.S.-based breast implant procedures utilize smooth implants, the opposite held true for much of the rest of the market.
Six U.S. women who had textured breast implants used in their augmentation procedures have sued Allergan over their increased cancer risk and allege that the corporation deliberately deceived the public by submitting misleading and, in some cases non-public, reports to regulators. The plaintiffs allege that the pharmaceutical giant even used fictitious manufacturer names in its reports to draw attention away from Allergan itself.
For its part, Allergan denies the allegations and noted its “strong record of compliance” and “dedication to the health and safety of patients.”
Since its discovery, over 80% of the known cases of breast implant associated anaplastic large cell lymphoma have been tied to Allergan implants. And while the mere use of textured implants is shown to elevate a patient’s risk of developing BIA-ALCL, implants made by Allergan have specifically been shown to be six times more likely to cause the cancer than implants made by other manufacturers.
Complicating the matter further has been the FDA’s apparent lack of will to take decisive action on the issue. While some 16 domestic deaths may already be attributable to the cancer that, when mitigated early has a largely positive prognosis and can be treated with surgery alone in 85 percent of cases, the federal agency has simply continued to kick the can down the road and adopted a perpetual state of “evaluating the body of available evidence regarding the safety and risks of breast implants, including concerns specific to textured implants and the risk of BIA-ALCL.”
As has been the case time and time again, it may wind up being individual action by those affected rather than federal oversight by those who exist merely to placate their lobbyist overlords that creates enough momentum to change this situation.