FDA Approves Teardrop-Shaped Silicone-Gel Filled Breast Implant

Mentor got approval for MemoryShape after collecting six years of data from 955 women that demonstrated “a reasonable assurance” of safety and effectiveness, FDA officials reported to NBC News Health. Mentor’s MemoryShape breast implants are shaped like a teardrop with greater fullness in the lower half, mimicking the silhouette of a natural breast. They are filled with a silicone cohesive gel that Mentor claims enables shape retention.

The MemoryShape implants showed similar complication rates as those in other approved implants, including tightening of the area around the breast, need for reoperation or implant removal, uneven appearance and wrinkling. Cracks were seen in the gel of some MemoryShape implants, according to the FDA.

With the recent approval of Mentor’s MemoryShape, there are now five FDA-approved silicone-gel filled breast implants available. This is big news because the reappearance of silicone-gel filled breast implants in 2006 may arguably be a cause of the general breast implant boom.

Before breast implants came back on the market only 19 percent of breast augmentation procedures used silicone. In 2012, according to statistics released by the American Society for Aesthetic Plastic Surgery (ASAPS), 72 percent of the 330,631 breast augmentation procedures in the U.S. used silicone implants, while only 28 percent used saline. Further, according to ASAPS… “one can speculate that the total increase in breast augmentation procedures in 2012 (330,631 compared with 316,848 in 2011), and the comeback of breast augmentation as the number one plastic surgery procedure in the U.S., is because women can choose silicone, which, according to patients and surgeons, feels and looks more natural.”

MemoryShape breast implants have been approved to boost breast size in women over 22 and to rebuild breast tissue in women of any age.  However, like the other companies offering these breast implants (Allergan and Sientra) Mentor is required to monitor the women who use them and research long-term effects. Here is a sampling of the FDA monitoring requirements that Mentor is required to fulfill:

• They must follow the 955 women in the core study for 10 years and follow 350 additional women implanted with a certain kind of MemoryShape device for five years.

• They must conduct a study of 2,500 women who get MemoryShape devices to track risks of long-term local complications for 10 years.

• They must 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.

• Finally, Mentor must also evaluate the women’s perceptions of package labeling and analyze returned MemoryShape products.

These stringent study requirements place an onus on breast implant manufacturers but are a blessing in that they safeguard American women. If you’re thinking about breast augmentation, a board-certified plastic surgeon can discuss these implants in detail.

Previous Post
Brilliant Minds!
Next Post

1 Comment. Leave new

  • Lisa Nicholas
    July 5, 2017 8:53 am

    This is the crystal clear information i have found thanks for your article. Can i share this with my community? because everyone should aware of this.


Leave a Reply

Your email address will not be published. Required fields are marked *

Fill out this field
Fill out this field
Please enter a valid email address.
You need to agree with the terms to proceed

View Our Photo Gallery of Plastic Surgery results in Virginia Beach, Newport News and Chesapeake

Schedule a Consultation for Plastic Surgery in Virginia Beach, Newport News, and Chesapeake

Dr Carney, Board-certified Plastic Surgeon with Offices in Virginia Beach, Newport News and Chesapeake

"*" indicates required fields

Ask Dr. Carney

This field is for validation purposes and should be left unchanged.

Client testimonials are based on personal experience. Individual results may vary.