FDA Approves New Silicone Gel Breast Implant
- Posted on: Mar 10 2012
The FDA has approved the silicone breast implant from the manufacturer Sientra. From the FDA website:
FDA approves new silicone gel-filled breast
Approval conditioned on post-approval safety studies
Today, the U.S. Food and Drug Administration approved a silicone gel-filled
breast implant manufactured by Sientra Inc. to increase breast size
(augmentation) in women at least 22 years old and to rebuild breast tissue
(reconstruction) in women of any age.
As a condition of approval, Sientra is required to conduct post-approval
studies that will assess long-term safety and effectiveness outcomes as well as
the risks of rare disease outcomes.
Silicone gel-filled breast implants are medical devices implanted under the
breast tissue or under the chest muscle for breast augmentation or
reconstruction. These implants have a silicone outer shell that is filled with
silicone gel. They come in different sizes and have either smooth or textured
With today’s approval, there are now three FDA-approved silicone gel-filled
breast implants in the U.S. manufactured by Allergan, Mentor and Sientra.
“Data on these and other approved silicone gel-filled breast implants
continue to demonstrate a reasonable assurance of safety and effectiveness,”
said William Maisel, M.D., M.P.H., deputy director for science in the FDA’s
Center for Devices and Radiological Health.
“It’s important to remember that breast implants are not lifetime devices.
Women should fully understand risks associated with breast implants before
considering augmentation or reconstruction surgery, and recognize that long-term
monitoring is essential.” said Maisel.
The FDA based its Sientra approval on three years of clinical data from 1,788
participants. Complications and outcomes reflected those found in previous
studies of other breast implants and included tightening of the area around the
implant (capsular contracture), re-operation, implant removal, an uneven
appearance (asymmetry), and infection.
In June 2011, the FDA released a report that included preliminary safety data
from post-approval studies from earlier breast implant approvals. The experience
collecting and analyzing data from these studies informed the design and
structure of post-approval studies for Sientra breast implants.
In addition to other post-approval conditions, Sientra will:
- continue to follow the 1,788 clinical trial participants in their pre-market
study for an additional 7 years;
- conduct a 10-year study of 4,782 women receiving Sientra silicone gel-filled
breast implants to collect information on long-term local complications such as
capsular contracture, as well as less common disease outcomes, such as
rheumatoid arthritis and breast and lung cancer; and
- conduct five case-control studies that will evaluate the association between
Sientra’s silicone gel-filled breast implants and five rare diseases: rare
connective tissue disease, neurological disease, brain cancer, cervical/vulvar
cancer, and lymphoma.
“The design of these post-approval studies will require Sientra to collect
valuable safety information with adequate enrollment and follow-up,” said
Maisel. “The FDA is committed to working with breast implant manufacturers to
collect useful post-market data on long-term safety and effectiveness.”
My comment: This is a big deal in the plastic surgery field. Mentor and Allergan (aka McGhan) have been the only real players in the breast implant market for 20 years. Although Sientra’s implants are now approved for use, their products remain unknown to the vast majority of plastic surgeons. Study results have not been publicly released (to my knowledge), and therefore how Sientra’s implants stack up to Mentor and Allergan’s is still in question.
Breast augmentation is the number one cosmetic plastic surgery in the country, with over 300,000 women undergoing the surgery each year according to the American Society of Plastic Surgeons. If Sientra’s implants test as well as the other two companies AND have a lower price, then we may see more and more women being able to afford breast augmentation. I’ll report on the new Sientra silicone breast implant as information is released.
Posted in: Plastic Surgery News