Boston Scientific Transvaginal Mesh. Thousands of women have been implanted with Boston Scientific transvaginal surgical mesh implants or pelvic slings during urogynecologic procedures to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Unfortunately, many vaginal mesh and sling devices manufactured by Boston Scientific have been associated with a high rate of complications. Women throughout the country have filed Boston Scientific transvaginal or pelvic mesh lawsuits seeking compensation for serious injuries, including erosion and extrusion of mesh, perforation of organs, vaginal bleeding, chronic infection, pain and emotional distress.
Transvaginal mesh products made by Boston Scientific include:
- Advantage Transvaginal Mid-Urethral Sling System
- Pinnacle Posterior Pelvic Floor Repair Kit
- Obtryx Transobturator Mid-Urethral Sling System
- Polyform Synthetic Mesh
- Prefyx Mid U Mesh Sling System
- Prefyx PPS System
- Uphold Vaginal Support System
These surgical mesh implants are intended to act as a hammock to support prolapsed organs and improve symptoms associated with POP and SUI. Boston Scientific transvaginal surgical mesh products are implanted during POP repair to provide support for the female’s pelvic organs when they drop, fall, bulge or protrude (prolapse) into the vaginal wall due to weakened or stretched muscles that occur from childbirth, pregnancy and other causes.
These surgical mesh devices can be implanted to repair prolapse of the bladder (cystocele)
These surgical mesh devices can be implanted to repair prolapse of the bladder (cystocele), top of the vagina (apical prolapse), uterus (procidentia), rectum (rectocele), bowel (enterocele) and urethra.
In August 2011, more than 500 Boston Scientific Pinnacle Pelvic Floor Repair Kits were recalled. According to the FDA notice, the Pinnacle kits may have low tensile strength between the needle and suture, leading to needle detachment during mesh placement.
Furthermore, the agency has stated that these complications are “not rare.” Complications linked to mesh implants include:
- Erosion of mesh through vaginal tissue
- Exposure or extrusion of mesh, where mesh moves through vaginal tissue
- Feeling a lump in the opening or something protruding from the vagina
- Painful sexual intercourse
- Perforation of the bladder, intestines, bowels and blood vessels around the vaginal wall
- Recurring POP
- Recurring SUI
- Urinary problems
- Vaginal bleeding
- Vaginal chronic damage, discharge and infections
- Vaginal pain
- Vaginal scarring and shortening
According to an FDA safety communication issued on July 13, 2011, 2,874 new reports of complications — 1,503 involving POP repairs and 1,371 involving SUI repairs — associated with transvaginal surgical mesh procedures were made to the agency from January 2008 through December 2010.
Studies reviewed by the FDA also indicated that roughly 10 percent of women who undergo a procedure involving transvaginal placement of surgical mesh will suffer mesh erosion within 12 months of surgery. More than half will need to undergo an additional surgery to remove the mesh, but in many of these cases, the excision procedure will not resolve their mesh failure symptoms.
The FDA was unable to find conclusive evidence showing that transvaginally placed mesh in POP repair
The FDA was unable to find conclusive evidence showing that transvaginally placed mesh in POP repair is more effective than traditional non-mesh repair in all patients with POP and that “it may expose patients to greater risk.”
Public Citizen, the consumer advocacy group founded by Ralph Nader, petitioned the FDA on August 25, 2011 to recall transvaginal mesh products due to safety considerations and their association with painful and debilitating complications.
During a meeting convened in September 2011, a majority of outside experts on the FDA’s Obstetrics & Gynecology (OB/GYN) Medical Device advisory panel agreed that the safety, effectiveness and benefit of transvaginal mesh devices in POP repair has not been well established and warrants long-term prospective follow-up of patients.
The FDA is considering a proposal to reclassify transvaginal mesh devices used in the repair of POP to Class 3 from their current Class 2 designation, thereby making surgical mesh for POP repair ineligible for the FDA’s less-stringent 510(k) approval protocols, and require that such devices be subjected to human clinical trials in order to gain FDA approval for this use.
A number of women have filed lawsuits over transvaginal mesh devices made by Boston Scientific. These lawsuits claim that the products are defective and lead to various complications, including:
- Additional surgery and multiple revision surgeries
- Emotional distress
- Loss of ability to have sexual relations
- Loss of quality of life
- Lost wages
- Out-of-pocket medical, surgical and hospital expenses
- Pain and suffering
- Spousal loss of consortium
The Plaintiffs in these cases also claim that the manufacturers knew about these risks and failed to warn consumers. With growing evidence suggesting that the use of transvaginal mesh is unsafe, litigation is only expected to grow.
Need Legal Help Regarding Transvaginal Mesh?
If you or someone you know suffered injuries after being implanted with a Boston Scientific transvaginal mesh product, you may have valuable legal rights. Our firm is representing numerous women in lawsuits over transvaginal mesh products. To find out more about pursuing a lawsuit or to get free legal advice from one of our attorneys, please fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).