FDA Approves New Silicone Gel Breast Implant With Restrictions
July 7, 2013
The U.S. Food and Drug Administration (FDA) has approved a new silicone gel breast implant manufactured by Mentor Worldwide LLC, with strict requirements. The manufacturer is required to closely monitor the women who use it and research the long-term effects. The Mentor MemoryShape breast implant has been approved by the FDA for the use of increasing breast size in women aged 22 years and older and to rebuild breast tissue in women of any age.
In a statement, an official from the FDA said that the new approval is based on six years of data from 955 women that demonstrated “a reasonable assurance” of safety and effectiveness. The Mentor MemoryShape breast implant showed similar rates of complications as those found in previously approved implants. These complications include tightening in the area around the breast, a need for re-operation or implant removal, an uneven appearance and wrinkling.
The FDA approval came with the condition that Mentor, the manufacturer, continues to follow the 955 women in the core study for 10 years and that they follow 350 additional subjects implanted with a certain kind of MemoryShape device for five years. In addition, the manufacturer must conduct a study of 2,500 women who get MemoryShape devices to track risk of long-term local complications for 10 years and conduct five case control studies of some 10,750 women to evaluate the potential association of any silicone breast implants and five rare diseases: rare connective tissue disease, neurological disease, brain cancer, cervical/vulvar cancer and lymphoma.
If you are considering breast implants and are concerned about the long-term safety of silicone breast implants, it is important to speak to a qualified physician before making a decision. Your OBGYN can discuss your risks and help you find more information to help you determine if silicone breast implants are safe for you.
Posted on the Behalf of Marietta OB-GYN Affiliates, P.A.