New MemoryShape Implants Approved by FDA
July 7, 2013 - By Dr. Jules Feledy
When it comes to breast implants, one size does not fit all. There are many different types of implants to choose from, and differences range from shape, size, the type of material it’s filled with, and even where in your body they’re placed. Well, a new type of implant has joined the family.
The U.S. Food and Drug Administration recently gave the go-ahead to Mentor Worldwide LLC to sell their make of silicone implant, the MemoryShape, on the American market. The product has been approved for breast augmentation in women aged 22 or older, and for breast reconstruction surgery in women of any age. It’s been available in other markets for years, but this is the first time it’s been made available to American customers.
10 Year Study Leads to Approval
This approval stems on the ongoing 10-year study on the product, now in its sixth year. The study follows 955 reconstruction and augmentation patients, and in that time, the study has shown a low rate of “adverse effects,” and the FDA is satisfied that there’s a reasonable assurance of the product’s safety as compared to other implants that have received the stamp of approval.
With MemoryShape on the market, there are now five FDA-approved silicone implants available in the U.S., as produced by three manufacturers: Allergan, Sientra, and of course, Mentor. This is only good news for the patient, as variety means more options, and competition means prices could even out a bit in the long run.
If you’re interested in breast augmentation, the first thing on your to-do list isn’t to pick out the implant you like best – it’s to seek out a consultation with your plastic surgeon, who can best advise you on what the best options are based on what you’re looking for.