A woman who received silicone breast implants after a double mastectomy has sued the implant maker for blindness, sensitivity to chemicals, and immune system problems she developed after the implant gel “bled” into her system. (Weber v. Allergan, Inc., No. 2:12-cv-02388 (D. Ariz. filed Nov. 7, 2012).)
Silicone is a polymer compound used in adhesives, sealants, cookware, and lubricants. Silicone breast implants, first introduced in 1962, have an elastic-like silicone shell filled with gel silicone. By 1992, there had been widespread reports of implant leakage and rupture, and they were suspected of a link to cancer and connective tissue disease. The FDA removed all silicone implants from the market until manufacturers could prove their safety and effectiveness. In 2006, the FDA approved silicone implants made by Allergan, Inc., and Mentor Worldwide, but required that they conduct extensive post-approval studies on the devices’ long-term safety. The studies are ongoing.
After Nicole Weber was diagnosed with zero-stage breast cancer in March 2009 and opted for a double mastectomy, she saw breast reconstruction surgeon Bryan Gawley about having implants inserted. Gawley recommended silicone implants over saline implants, saying they were more natural looking and she would not be happy with the saline ones. He assured her that the previous problems with silicone implants were gone and there was no risk of rupture. According to the complaint, Gawley said that “there was a fringe group of women who were kooks that claimed they experienced problems attributable to silicone implants.” Weber agreed to the silicone implants.
Gawley did not tell her that he was working as a surgeon “investigator” for Allergan while it conducted its study. During a preoperative appointment, Gawley gave her a questionnaire that he said was to help cancer patients without telling her that the sponsor of the survey, “BIFS,” was actually Allergan and that the study was for its FDA-ordered Breast Implant Follow-up Studies program.
“She had no reason to believe it was a clinical trial or that it was the device manufacturer that was the entity submitting the survey,” said Weber’s attorney, Alan Milstein of Moorestown, N.J. The complaint says “[i]t was clear that Dr. Gawley’s goal was to convince Ms. Weber to choose silicone implants over saline.”
A few months after the surgery, Weber complained to Gawley that the implants were very tight and uncomfortable. He allegedly told her that there were no problems with the implants and that she “should simply face the reality that the implants were going to be tight.” At that point, she filled out her first annual survey for BIFS and checked “no” to all of the symptoms listed; tightening was not on the list.
Several months later, Weber began experiencing migraines so debilitating that she went to the emergency room several times. She also suffered severe lung and breathing difficulties, tinnitus, vertigo, fungal feet, and allergic reactions to medicines, among other conditions. Then she started experiencing vision loss. She saw several doctors to find out why she was losing her sight, but it wasn’t until she received her second annual BIFS survey that she realized the implants might be to blame.
“After she filled out a form where she checked off all these things that she was experiencing, she realized there was a connection,” said Milstein. “That’s what led her to connect the dots. Who’s going to connect eyesight to breast cancer and implants?”
Finally, Gawley told her that other doctors believed the implants could be causing her problems and needed to be removed. He confirmed that the implants had not ruptured but had probably “bled” so that some of the gel diffused through the intact shell and got into her system. Weber was eventually diagnosed with autoimmune retinopathy, in which antibodies attack the retina. Her blindness cannot be reversed. She also has extreme sensitivity to all medications and immune system problems.
Weber’s suit alleges Allergan misrepresented the implants’ dangers and used inadequate labeling. She also claims the company did not adequately test its implant system, failed to fix known harms, and carelessly designed its BIFS study.
Although the FDA concluded last year that clinical trials to date have found no connection between silicone implants and autoimmune conditions, there is a growing—but controversial—movement in the science community to recognize Autoimmune Syndrome Induced by Adjuvants (ASIA). Adjuvants are substances that stimulate an immune response to antibodies, and silicone is one of them. The journals Lupus and the Journal of Autoimmunity have run several articles and studies supporting ASIA.
“It seems that the role of adjuvants in the pathogenesis of immune-mediated diseases can no longer be ignored, and the medical community must look forwards to producing safer adjuvants,” said the authors of an editorial in Lupus. They noted that the “link between silicone, a synthetic polymer, and immune-mediated diseases has been accepted by the medical community.”