The FDA (US Food and Drug Administration) has approved the new firmer MemoryShape breast implants for breast augmentation in women aged 22 years or more. The new type of implant promises “a more natural shape and youthful feel”.
The approval has come following a trial involving 955 patients who were followed up for six years. The data provides "reasonable assurance of safety and effectiveness for this implant" but there are still a number of risks associated with the product.
The rates of complications and outcomes associated with the MemoryShape breast implants were similar to those found in other breast implants that are already on the market. Reported complications included capsular contracture (tightening around the implant), asymmetry (the implant looks uneven), wrinkling, and implant removal. Fissures or cracks were observed in the gel of some of the new implants.
Jeffrey Shuren, Director of the FDA’s Centre for Devices and Radiological Health, has reminded patients that breast implants are not lifetime devices and women should fully understand the risks associated with them before considering augmentation or reconstruction surgery, and the need for long-term monitoring.
However, the recent PIP implant scandal has shaken the industry and the FDA has only granted approval on the condition that Mentor Worldwide LLC, which manufactures the implants, monitors the women who use it and researches long-term effects.