Recently, a lawsuit has been filed against Allergan, an Irish medical device manufacturer, by individuals who have had certain textured breast implants put in.
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. Based on the currently available information, the FDA’s analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan’s BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL.
Of the 573 worldwide reported total cases of BIA-ALCL, 481 patients are reported to have Allergan breast implants at the time of diagnosis. Of those cases, 12 deaths occurred in patients implanted with an Allergan breast implant at the time of their BIA-ALCL diagnosis.
Although Allergan Natrelle 133 and 133 Plus tissue expanders have not been associated with BIA-ALCL to date, both devices have the same Biocell texture. While tissue expanders are only indicated to be used for 6 months, to date there is no information on what duration of exposure to the Biocell texture may induce BIA-ALCL.
Imagine surviving cancer, only to have to go through the anxiety of a possible diagnosis all over again. Read the stories of women here:
Here is a list of the recalled products: https://www.biocellinformation.com/affected-products
If you have had one of these devices implanted, contact our office. We have the experience and compassion to help you make your case. You do not have to have a diagnosis of lymphoma as of yet to file.