In 1979, John Avele and Pete Nicholas founded Boston Scientific, and created a worldwide company that produces, markets, and manufactures a wide variety of medical products. Boston Scientific was the first manufacturer to produce transvaginal mesh. It’s first mesh product was ProtoGen, which launched in 1996.
Rapidly, competitors created similar products, which all quickly passed through clearance requirements through the FDA’s 510(k) clearance system. This system allows medical manufacturers to skip over human testing and send products straight to market as long as their product is similar to one that’s already been approved.
Transvaginal Mesh Devices
Transvaginal mesh is a synthetic or biologic material permanently implanted in women to repair pelvic organ prolapse (POP) or to support the urethra as a treatment for stress urinary incontinence (SUI), conditions which arise when the vaginal wall and other supporting muscles have been weakened. This weakening often occurs as a consequence of pregnancy and childbirth, and may also arise from other factors, including aging.
In some cases, the treatment works as planned and women experience dramatically improved quality of life through a relatively mild surgery. However, in many cases, the mesh shrinks once inside the vagina, causing vaginal shortening, tightening, and intense pain. Another more serious possibility is that part of the mesh material does not get absorbed into the tissue as intended and instead remains free inside the pelvic area. The U.S. Food & Drug Administration (FDA) has determined that transvaginal mesh may cause complications such as the erosion of the product into surrounding areas of the pelvis and perforation of pelvic organs.
In 1999, just three years after Boston Scientific launched ProtoGen, it voluntarily recalled the product due to safety concerns. Most recently, in 2011 they recalled their Pinnacle Pelvic Floor Repair Kit. Although this recall was unrelated to the mesh itself, it raised further concerns about the possible negative health consequences from the device.
In September 2014, a jury in Texas ordered Boston Scientific to pay $73 million in punitive and compensatory damages to Martha Salazar, who was injured and left in constant pain by its Obtryx sling. Punitive damages were later reduced in the case to comply with Texas law, reducing the total judgment to $34 million.
Currently, Boston Scientific is one of the major manufacturers of transvaginal mesh named in the multidistrict litigation case being held in West Virginia.
We Can Help
If you or a loved one had transvaginal mesh implantation and developed complications, you may be entitled to financial compensation. Recovery may include compensation for your medical bills, pain and suffering, lost wages, and loss of spousal consortium. Avram Blair & Associates P.C. is headquartered in Houston, Texas but handles transvaginal mesh cases nationwide. To find out if you have a claim, please call Avram Blair & Associates P.C. at 919-729-5152?? or contact us online for your free consultation.