ProteGen Vaginal Sling

There are potentially serious injuries associated with a popular treatment for feminine urinary stress incontinence.

The ProteGen Vaginal Sling is a synthetic polymer implant designed to provide added bladder support and relief from urinary incontinence.

The device has caused serious problems such as vaginal erosion, infection, discharge, odor, dehiscence (splitting of the skin) and other complications which may require removal of the device and additional surgeries. In some cases, infection may be severe enough to cause nerve damage, usually numbness in the lower body.

The ProteGen Vaginal Sling was on the market from April 1997 until January 1999, when it was withdrawn by its manufacturer, Boston Scientific Group. The FDA found the device to be "adulterated and misbranded" because of its side effects. The withdrawal applied only to new, unused devices --- not to those already implanted.

Women who have the ProteGen Sling may not have been told about its potential dangers nor advised to have it removed. Women who have been implanted with the ProteGen Sling should consult their doctor regarding any possible side effects, even if the device has already been surgically removed.