Lawsuit Filed Over Allergan Breast Implants After FDA Recommends Boxed Warning
Two women in Florida have filed a lawsuit against Allergan, the manufacturer of textured breast implants, which were recalled by the U.S. Food and Drug Administration (FDA) because they have been linked to a rare form of cancer. According to the Miami Herald, the lawsuit, which was filed in federal court in the Middle District of Florida, is seeking $5 million in damages and class action status. At the heart of the lawsuit are surgical costs associated with removing and replacing the textured breast implants, costs that Allergan is not offering to cover.
The lawsuit states that this would leave the women with the horrific choice of removing the implant and paying surgical costs out of pocket, or living in fear knowing that they could develop cancer because of their breast implants. The lawsuit alleges that Allergan breached its implied contract by selling a product that posed a risk to patients and has unjustly profited at the expense of the affected women. Similar lawsuits were filed in August and September.
FDA Recommends Strong Warning
Meanwhile, the FDA has released a draft guidance recommending a “boxed warning” on labeling materials for breast implants. Boxed warnings alert health care providers and consumers of serious risks associated with a drug or medical device, and are the strongest form of warning required by the FDA for labeling.
The FDA has recommended that the warning clearly states that textured breast implants have been linked to the development of cancer of the immune system called breast implant-associated anaplastic large cell lymphoma or (BIA-ALCL). The recommendations have been put forth by the FDA for public comment and review. They are draft guidance and have not yet been finalized.
Pursuing Your Legal Rights
Compared with implants that have a smooth outer surface, textured breast implants provide more friction with the surrounding tissue and thereby are more likely to stay in place. Several companies including Allergan, make textured implants. The FDA recalled Allergan’s BIOCELL textured breast implants in July because of the heightened risk of BIA-ALCL. FDA officials said the risk of developing cancer with Allergan’s BIOCELL textured implants was nearly six times the risk of developing cancer from textured implants made by other companies.
If you or a loved one has developed cancer as a result of these textured breast implants you may be able to seek compensation for damages including medical expenses, lost income, hospitalization, cost of rehabilitation, permanent injuries, disfigurement, pain and suffering. An experienced product defect lawyer who is handling Allergan’s textured breast implant cases can help you pursue your legal rights and secure maximum compensation for your losses.