Frequently Asked Questions About MemoryGel Silicone Breast Implants
A Brief History of MemoryGel Silicone Breast Implants
Mentor Worldwide LLC has been in the business of manufacturing medical devices since 1969. After more than a decade of selling electronic lab instruments, the company began developing breast implant devices, which have now been used for more than five million surgeries. In December of 2003, Mentor Worldwide LLC submitted a pre-market approval application for a new product, MemoryGel Silicone implants. In November 2006, the FDA granted permission for the implants to be used in breast augmentation and reconstruction surgeries as long as certain requirements were followed. The approval was contingent upon six-part post-approval studies that were required to be conducted once the product was launched. These studies were intended to characterize the safety and effectiveness of MemoryGel devices and to answer scientific questions the pre-market clinical tests did not. The required studies included assessing the long-term performance of the devices, documenting rare adverse events and device failures, and improving patient labeling.
The plaintiffs in the suit argue that in order to fulfill this responsibility, Mentor should have closely monitored the information that became available through the post-market studies and provided updated safety not only to the FDA, but also to the healthcare community and consumers. Failing to do so could have prevented researchers and those in the medical community from quickly identifying any potential health and safety issues associated with using the device. The plaintiffs believe the manufacturer failed to fulfill these responsibilities and warn consumers about the serious health risks with the MemoryGel Silicone implants.