The ProteGen Sling is a woven polyester sling-like Trans-Vaginal Mesh implant. Boston Scientific introduced the sling into the marketplace in 1997, as a treatment for feminine stress urinary incontinence – a condition that causes urine leakage while coughing, laughing, or undergoing physical activity. During the procedure, surgeons implant the “sling” underneath the bladder and anchor it to the pelvic bones. The mesh then provides support to the pelvic muscles, thereby reducing the “stress” that can cause urinary leakage. The term “ProteGen” refers to the fact that the slings were treated with bovine collagen.
Problems with infection and mesh erosion began to arise shortly after the ProteGen Sling went into use. Boston Scientific reportedly received over 500 complaints about mesh injuries before it issued a ProteGen sling recall in December of 1999. Approximately 23,000 ProteGen Slings were distributed during the two years the product was on the market.
In an article published in the American Journal of Obstetrics & Gynecology in July of 2009, the authors contend that the ProteGen Sling was “rushed to market for financial reasons without adequate premarket clinical trials.” On October 20, 2008, and July 13, 2011, respectively, the U.S. Food and Drug Administration issued warnings about reported complications arising from Trans-Vaginal Mesh use.
The major complications associated with the sling are mesh erosion and infection. In many cases, the sling’s synthetic material has worn or eroded. Sharp mesh fragments created by the erosion can pierce through the walls of a woman’s urethra or vagina, causing severe secondary complications such as bowel and bladder damage, and recto-vaginal fistula. The mesh fragments can perforate nearby organs as well.
These complications require surgical removal of the implant. However, because body tissue often becomes entwined with the mesh, removal is a difficult task that often requires more than one surgery. Depending on what other complications have arisen because of the mesh erosion, other surgeries may also be required as well.
Thousands of women have filed product liability lawsuits against Boston Scientific since the ProteGen Sling recalltook place. The federal cases were consolidated into multidistrict litigation in a federal court in Maryland. In 2003 alone, the company settled over 700 ProteGen lawsuits. As the occurrence of Protegen complications has continued, so has the filing of lawsuits. In addition, other Trans-Vaginal mesh products are currently the focus of mass product liability cases, including suits against Johnson & Johnson over its Gynecare Prolift sling.
An injured person may file a product liability lawsuit against Boston Scientific. Under product liability law, a manufacturer may be liable for injuries caused by its products irrespective of any fault.