FDA Gives the Okay to the MemoryShape Breast Implants

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MemoryShape Breast Implants, the firmer silicon implant, that has now been approved by the Food and Drug Administration.  After six years of data was researched, they determined that the new implant was indeed safe for use. It was approved for breast reconstruction in any woman and for breast enlargement in those that are over 22 years of age. The new implant is marketed by Mentor Worldwide, a company out of Santa Barbara, California.

FDA Gives the Okay to the MemoryShape Breast Implants

After looking at 955 females’ data about the implants, it concluded that the complications and the outcomes from the implants were the same as the other breast implants that are currently on the market.

Some of these complications include:

  • Gel fracture
  • Asymmetry, or uneven implants
  • Wrinkling
  • Capsular contracture, or where there is tightening around the implant

New studies will now need to be conducted to test for the long-term safety on the implants. These post-approval tests will check for any rare disease risks. Mentor Worldwide have to conduct these tests or have their FDA backing pulled. According to the FDA, Mentor’s MemoryShape Breast Implants are granted approval on certain conditions. These conditions include follow up on the 955 women in the pre-study. That follow up has to be a minimum of a ten year study to check for any mishaps.

Other conditions include monitoring the women that got the “medium-height moderate profile” implants, numbering about 350 women. These tests must be at a minimum of five years to check for any complications. They also need 10,750 women to be in five case control studies to see if there is a link between gel implants and lymphoma, brain cancer, rare connective tissue disease, cervical or vulvar cancer, and any neurological disease.

The difference between these new gel implants and regular silicon implants is that then MemoryShape implants have an unique shape. The MemoryShape implants are tear-drop in design instead of round, so they will have the more natural looking appearance upon implantation. The gel itself is made with a specific formula that will maintain shape, so that the feel goes along with the look. Silicon that is made to feel and look more natural than other formulas all in a special-shaped casing.

These new implants work well in both breast reconstruction cases and in breast augmentation cases. Rebuilding the breast tissue or enhancing, both will see a more natural silhouette with the way that MemoryShape implants are designed.

Partners in Plastic Surgery of West Michigan doctor Dennis Hammond was the lead investigator of the clinical trial for the MemoryShape gel breast implant and stated ” I am pleased women in the U.S. now have an implant that offers an enhanced yet subtle breast appearance with a proven safety profile.” He was pleased by the formed implant and how it allowed for a more cohesive appearance in women.