Vassallo underwent breast implant surgery in 1977. Fifteen years later, she underwent a mammogram after suffering from chest pains under her left armpit. The mammogram showed that the breast implants had possibly ruptured. The silicone gel implants were removed and replaced with saline implants. During the surgery, the surgeon noted severe, permanent scarring of Vassallo’s pectoral muscles that was attributed to the silicone gel. The left implant had ruptured and the right had several pinholes through which the silicon could escape. During trial, evidence indicated that by 1977, Heyer-Schulte, the manufacturer, knew its implants were not consistent as far as durability or destructibility. Heyer did not warn of the consequences of gel migration in the body, also, Heyer-Schulte conducted few animal and no clinical studies regarding the safety of its silicone gel implants. While Heyer-Schulte did furnish warnings to doctors, they did not
address the possibility of gel bleed, ruptures or the consequences of silicon gel escaping into the body. Vassallo stated that if she had known that the implants could cause permanent scarring, chronic inflammation, and problems to her immune system, she would not have gone ahead with the procedure.