An Arizona woman has filed a product liability lawsuit against Allergan, alleging that she suffered a number of complications from the company’s Natrelle silicone breast implants, including neurological problems and vision loss.
The silicone breast implant lawsuit (PDF) was brought last month in the U.S. District Court for the District of Arizona by Nicole Weber, who indicates that after she suffered silicone bleeding into her body from the Natrelle implants.
According to the complaint, Weber received the implants in 2009, following a bilateral mastectomy due to breast cancer. Weber alleges that the Allergan Natrelle silicone breast implants were defectively designed and also claims that she was unwittingly enrolled in a safety study for the implants, without consent.
Weber indicates that her plastic surgeon, Dr. Bryan W. Gawley, directed her toward silicone implants despite her concerns about the safety of the device, telling her that they were proven safe and that the only women who were “kooks” complained about silicone implant problems.
The lawsuit claims Dr. Gawley was actually an investigator with the Breast Implant Follow-Up Studies Program (BIFS) and an agent for Allergan; information he failed to pass on to Weber.
BIFS is a 10 year prospective study ordered by the FDA after the silicone breast implants were allowed back on the market in 2006, following a 14-year ban. The study has the goal of recruiting 50,000 subjects.
Weber claims she was told to fill out BIFS questionnaires, but was never informed that she was part of a safety study on breast implants or that BIFS was related to Allergan.
After receiving the Natrelle silicone implants, Weber indicates that she began to experience complications that included tightness of the breasts, migraines, involuntary jerking and vision loss. Dr. Gawley repeatedly told her that the complications could not be caused by the Natrelle implant until they began to be more pronounced. Other specialists then told her that she had silicone sensitivity, after which Gawley suggested the implants might be bleeding into her body.
Weber had another plastic surgeon remove the implants in 2011, while Dr. Gawley continued to express doubt that they were causing her problems. Although many of the complications were alleviated with the removal of the implants, she continues to experience vision problems and problems with her immune system and extreme sensitivity to medications.
Weber is suing Allergan for product liability and negligence, and is seeking damages for financial loss, medical expenses, permanent injury, mental and physical pain and suffering and other damages.
Silicone Breast Implant Problems
In recent years, the FDA has issued several warnings to consumers regarding silicone breast implant side effects.
Women who are considering receiving silicone gel-filled breast implants have been advised by federal health regulators that they should be aware that the implants are not lifetime devices and that the longer they have them, the more likely they are to suffer complications.
In January 2011, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer. No cases of ALCL were diagnosed among participants in the latest study.