Who Manufactures Mesh? Boston Scientific
Boston Scientific was the manufacturer of the very first vaginal sling device: the ProteGen. The ProteGen was approved in 1996, but Boston Scientific requested that the FDA recall it three years later because of unexpected complications. Unfortunately, the many devices that used ProteGen as a predicate for clearance of their own transvaginal mesh devices were not recalled or subject to new testing themselves.
Despite the recall of this initial product, several Boston Scientific transvaginal products remain on the market, including:
- Pinnacle pelvic floor replacement kit
- Polyform Synthetic Mesh
- Prefyx Mid U Mesh Sling System
- Uphold Vaginal Support System
- Obtryx Transobturator Mid-Urethral Sling System
Currently, there are over 3,500 claims pending against Boston Scientific. Women who have had these devices placed have experienced the following complications:
- Pain during intercourse
- Recurrent infection
- Organ perforation
- Revision surgeries
- Pain and bleeding
If you have had a mesh or sling device inserted for relief from stress urinary incontinence or pelvic organ prolapse and have experienced these or other complications, we want to help you. The consequences are not only physical, but emotional and financial as well. Join the thousands of women like you and hold the manufacturers of these defective devices responsible. Contact Kirkendall Dwyer LLP today.