New FDA-approved teardrop-shaped silicone-gel filled breast implant
June 28, 2013
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.
The American Society for Aesthetic Plastic Surgery (ASAPS), is recognized as the world’s leading organization devoted entirely to aesthetic plastic surgery and cosmetic medicine of the face and body. ASAPS is comprised of over 2,600 Plastic Surgeons; active members are certified by the American Board of Plastic Surgery (USA) or by the Royal College of Physicians and Surgeons of Canada and have extensive training in the complete spectrum of surgical and non-surgical aesthetic procedures. International active members are certified by equivalent boards of their respective countries. All members worldwide adhere to a strict Code of Ethics and must meet stringent membership requirements.
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