PHOENIX (CN) - A breast cancer survivor says in Federal Court that the Allergan silicone implants she received after a mastectomy gave her migraines, fungal feet and vision loss.
Nicole Weber says her cancer surgeon recommended that she discuss reconstructive surgery options with (nonparty) Dr. Bryan Gawley after undergoing a bilateral mastectomy in July 2009 at the age of 53. Weber says she had the surgery after receiving a diagnosis of zero-stage breast cancer.
Gawley told Weber that silicone implants were very safe, and "that there was a fringe group of women who were kooks that claimed they experienced problems attributable to silicone implants, but they were just kooks," according to the complaint.
Weber says Gawley was an investigator for Allergan's Breast Implant Follow-up Studies program, a 10-year study of silicone implants, and that "it was clear that Dr. Gawley's goal was to convince Ms. Weber to choose silicone implants over saline."
Allergan is the sole defendant named in Weber's complaint.
Gawley represented that there was absolutely no chance of rupture and that he had no problems with the new silicone implants in his practice," according to the complaint.
H even "related a well-rehearsed story of his one and only problem case which involved a woman who was a professional dancer who repeatedly banged her breast on the dance pole, causing her implant to explode," the complaint states.
The implication allegedly being that, "unless she was planning on taking part in that activity, there was no chance of rupture."
At a follow-up appointment about eight months after her implant surgery, Weber said she told complained to Gawley "of severe pressure and discomfort from tightening of the implants."
But Gawley allegedly told Weber that the implants were fine, and she should "simply face the reality that the implants were going to be tight."
Weber says she began experiencing significant vision loss in March 2011. By October, nearly two years after getting the implants, Weber had experienced "six weeks of daily migraines; severe lung and breathing difficulties; severe anxiety; tinnitus; severe vertigo; racing heartbeat; large red strawberries on arms and fungal feet; allergic reactions to all medications; severe chest spasms and tremors and vision loss," according to the complaint.
Weber says her migraines were so bad "that she required weekly visits to the emergency room, as well as an urgent care facility."
Gawley allegedly informed Weber on or about Oct. 5, 2011, that the implants could be causing her health problems and may need to be removed.
The Arizona Center for Advanced Medicine concluded a week later that Weber had presented a severe generalized reaction to silicone, according to the complaint.
Weber says she had the implants removed on Oct. 20, 2011, by "Dr. Lu-Jean Feng who attributed all of her problems, including her vision problems, to the implants."
"The pathology report documented the following: associated foreign body-type multinucleated giant cells surrounding implants," according to the complaint.
Weber says she that she "gradually began to regain her health with respect to her tinnitus, chest spasms, migraines, foot funguses and anxiety" after the implants were removed.
But she says she was diagnosed this spring with autoimmune retinopathy, an inflammatory condition where a person's immune system attacks the person's vision.
Weber wants damages from Allergan for product liability and negligence. She is represented by Alan Milstein of Sherman, Silverstein, Kohl, Rose and Podolsky of Moorestown, N.J.
Read the Top 8
Sign up for the Top 8, a roundup of the day's top stories delivered directly to your inbox Monday through Friday.