The FDA’s Stance on Allergan Breast Implants Cancer

Why Was a Recall Issued for these Defective Medical Devices?

December 28, 2019 - Issues Associated with Allergan Breast Implants - A type of large t-cell lymphoma, breast implant-associated anaplastic large cell lymphoma, has been associated with Allergan textured breast implants. The immune system is attacked by BIA-ALCL and may not be diagnosed for many years following the implantation. At this juncture, it is theorized that the texture of the Allergan breast implants could trigger the lymphoma response in the body.  Although the FDA states BIA-ALCL—a form of non-Hodgkin’s lymphoma—is typically limited to the fluids and scar tissue surrounding the implant, the disease can spread to the lymph nodes, and even throughout the body.

The FDA’s Involvement with Allergan Breast Implants - Although a “possible” association between breast implants and BIA-ALCL was first identified by the FDA in 2011, there was not sufficient data at that time to ask for a recall of the breast implants. Years later, in March 2019, the FDA held a public advisory committee meeting in which women who had developed BIA-ALCL discussed their concerns with the agency.

A few months later, the FDA asked Allergan to recall the textured breast implants—BIOCELL and Natrelle silicone-filled and saline-filled textured implants, as well as certain tissue expanders. After the FDA report on the potential dangers of the textured breast implants, Allergan voluntarily recalled the implants. According to the FDA, these textured Allergan breast implants may be directly tied to more than 500 cases of BIA-ALCL, and twelve deaths.

At this point, the FDA is not recommending that women who have received a recalled Allergan breast implant immediately have the implant removed. The recommendation of the agency is that women should speak with their physicians, perhaps having tests to determine whether BIA-ALCL is present, then make the decision regarding removal of the textured breast implants. Women who have had no adverse response to their recalled Allergan textured breast implants may make the choice to leave the implants in place, keeping watch for any potential symptoms of the disease.

Is an Allergan Breast Implant Lawsuit Right for You? Those with an Allergan Natrelle or BIOCELL textured breast implant may have experienced symptoms of BIA-ALCL or other issues associated with Allergan textured breast implants. There has been a recent class action lawsuit filed against Allergan, and it is expected that a number of individual Allergan breast implant lawsuits will be filed in the coming months. Of the two women who filed the Allergan breast implant class action lawsuit, one has already been diagnosed with BIA-ALCL.

Whether you have already been diagnosed with BIA-ALCL, have had symptoms of the disease, or are simply worried about your future after implantation of a recalled Allergan textured breast implant, it could be beneficial to speak to experienced breast implant lawyers. Our breast implant lawyers have both the experience and the knowledge to help you with your Allergan breast implant lawsuit.

You may decide to move forward with an individual Allergan breast implant lawsuit or may decide to join an Allergan breast implant class-action lawsuit. Either way, we can help you determine the right course of action you for you and your individual circumstances. We can also answer any questions you may have regarding the recalled Allergan textured breast implants, what a diagnosis of BIA-ALCL could mean for you, and whether you should move forward with an Allergan breast implant lawsuit.

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Author: Andrew Sullo
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