UPDATE (November 17, 2014): A jury in Miami federal court ordered Boston Scientific Corp to pay four women a total of $26.7 million, Reuters reported. The plaintiffs suffered pain, bleeding, and infection after having the company’s Pinnacle mesh devices implanted to treat pelvic organ prolapse. The award was significant because it was the first federal bellwether trial for Boston Scientific, and the first trial that combined claims of four lawsuits. The jury awarded more than $6.7 million to three women and the fourth woman was awarded more than $6.5 million. The jurors found Boston Scientific’s Pinnacle pelvic mesh device was defectively designed and the company failed to warn physicians and their patients about the risks associated with using the defective bladder mesh device.
The Pinnacle is a Boston Scientific pelvic floor replacement kit, indicated for tissue reinforcement and stabilization of the pelvic floor for patients suffering from vaginal wall prolapse. Made of polypropylene knitted mesh, the vaginal sling is designed to function as a mechanical support or bridging material for any fascial defects in the pelvic region. The Pinnacle is one of several transvaginal devices that are under scrutiny by the FDA and healthcare professionals throughout the United States.
Transvaginal Mesh Products
Mesh slings inserted transvaginally were believed to be more effective in treating pelvic organ prolapse (POP) and involved a very simple surgical procedure with very little recovery time. Unlike traditional surgery that required an open surgery, Pinnacle and similar devices could be implanted through small incisions in the pelvic region. As a result, transvaginal mesh implants became increasingly popular with over 75,000 women receiving the treatments in 2011. But that same year, the FDA alerted the public of the thousands of adverse event reports related to the vaginal slings and warned that complications such as mesh erosion were not uncommon.
Once the mesh has been inserted, sagging organs are raised and supported by the mesh. According to the FDA, many patients experience mesh erosion or extrusion as the tissue begins to form through the porous mesh material causing intense pain and infection. Within the Boston Scientific Pinnacle’s prescriptive information, the manufacturer warns the use of the device may require:
- Hysterectomy from tissue in-growth and scarring
- Cervical length monitor due to possible shrinkages
- Regular pelvic exams
- Mesh removal/revision surgery
- Treatment for mild/moderate incontinence
- Apical repair for uterine enlargement
The full list of the Pinnacle’s possible complications and adverse events can be found on the Boston Scientific’s website.
Other Boston Scientific Transvaginal Mesh Products
Boston Scientific has been manufacturing transvaginal mesh products since 1996 when it debuted ProtoGen, the first vaginal sling. After receiving hundreds of adverse events reports, the company recalled the device in 1999 and settled hundreds of transvaginal mesh injury lawsuits for an undisclosed sum. Despite this, Boston Scientific has continued to produce, market, and sell similar devices that the FDA has now noted may be just as dangerous. In addition to the Pinnacle, Boston Scientific has also sold transvaginal mesh products under the names:
- Advantage Transvaginal Mid-Urethral Sling System
- Uphold Vaginal Support System
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
- Obtryx Transobturator Mid-Urethral Sling System
- Polyform Synthetic Mesh
File a Product Liability Claim
On July 2012, a California couple was awarded $5.5 million in compensation for the severe injuries caused by a defective transvaginal mesh. If you have also suffered severe health complications after being treated with a transvaginal mesh product, contact a professional product liability lawyer immediately to protect your rights to compensation. The statute of limitations for product liability claims differs for each state, to ensure your rightful compensation will not be compromised by any time limitations, schedule a free consultation with a knowledgeable attorney today.