|
|
|
|
MDA Advises Removal of Trilucent Implants |
| by Dr. Diane Gibby • M.D., P.A., F.A.C.S |
On June 6, the
U.K. Medical Device Agency (MDA) issued a Hazard
Notice recommending that women who have been
implanted with Trilucent breast implants
consider having them explanted. The implants
were sold in the U.K. from 1995 until 1999 when
the agency called for a voluntary suspension of
their use until further studies were completed.
The MDA issued the Hazard Notice, which also
calls for women with the soybean oil-filled
implants to avoid breast-feeding and conception
as a "precautionary measure" due to insufficient
information about the health risk of the
implant's filler material. Approximately 5,000
women in the U.K. have received these implants.
Fewer than 200 women in the U.S. have been
implanted with the implants during approved
clinical trials.
The MDA and the manufacturer of the implants
have received reports of local complications on
some women who have used them, including
swelling and inflammation of the breast. The
manufacturer voluntarily removed the devices
from the market in March 1999 and agreed to
perform further toxicological testing to address
concerns that potentially harmful breakdown
products may be created from soybean oil over
time. While there is no scientific proof of
definite health risks from use of the implants
the MDA has suggested that all women with
implants have them removed.
More information is available from the
manufacturer's site at
http://www.trilucentinfo.com
|
|
Diane Gibby, M.D., P.A., F.A.C.S Licensed in Texas, Dr. Diane Gibby is board-certified by the American Board of Plastic Surgery (ABPS) and the founder of The Women's Center for Cosmetic and Plastic Surgery. She is a member of the American Society of Plastic Surgeons (ASPS), American Society of Aesthetic Plastic Surgery (ASAPS), American Medical Association (AMA), Texas Society of Plastic Surgeons (TSPS), Dallas County Medical Society (DCMS) and the Board Certified Plastic and Cosmetic Surgeons of Dallas. She is also a Fellow in the American College of Surgeons (F.A.C.S.). Dr. Gibby's office is located at Medical City Dallas, Building C, Suite 820, (972) 566-6323. Individuals interested in brochures or names of qualified plastic surgeons in their area may call the American Society of Plastic and Reconstructive Surgeons at 1-800-635-0635.
|
|
|
|
