FDA: "ProteGen Sling Misbranded"
May 21, 2001
In January 1999, Boston Scientific Corporation recalled the ProteGen Vaginal Sling due to an alarming number of complications associated with the device. The ProteGen Vaginal Sling was developed to treat patients who suffer from urinary stress incontinence. Urologists implant the device under the bladder.
Unfortunately, the ProteGen Vaginal Sling has caused serious side effects in some women including infection, discharge, vaginal bleeding, foul odor, dehiscence, and erosion of the vaginal wall.
The Food and Drug Administration has supported Boston Scientific Corporation's decision to recall the device, stating that the agency "considers the devices to be adulterated and misbranded."
In December 1999, an article published in the Journal of Urology revealed the problems associated with the ProteGen Vaginal Sling. The author of the report recommends that women who have received the device "be followed closely."
-- Article Courtesy of InjuryBoard.com
More ...
- Chronic Fatigue Syndrome
- "$850,000 Settlement in New York Negligence Lawsuit"
- FTC Charges Canadian-Based Company with Making False Weight-Loss and Cellulite-Treatment Claims
.