ProteGen Pubo Vaginal Sling Recall
Boston Scientific made a device called a vaginal sling, marketed under
the name Protegen used in to treat feminine urinary stress incontinence.
The device has been withdrawn from the market because of its dangerous
complications.
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1999, when it was withdrawn by its manufacturer, Boston Scientific Group.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.
Contact our lawyers if you believe you may have been injured by this
device.
