If you were injured from POP or SUI repair that involved Boston Scientific transvaginal mesh, you are not alone. More than 23,000 transvaginal mesh lawsuits have been filed against Boston Scientific in state federal court. Side effects of transvaginal mesh include life-threatening infection, organ perforation, chronic pain, vaginal scarring, erosion of the mesh into the vagina, and more.
What You Can Do & How a Boston Scientific Vaginal Mesh Lawsuit Can Help
The Schmidt Firm, PLLC is currently accepting Boston Scientific vaginal mesh injury cases in all 50 states. If you or somebody you know has been injured by any type of Boston Scientific vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.
Boston Scientific Vaginal Mesh
The following transvaginal mesh products are manufactured by Boston Scientific:
- Uphold Vaginal Support System
- Polyform Synthetic Mesh
- Pinnacle Pelvic Floor Repair Kit
- Advantage Fit Sling System
- Obtryx Sling System
- Prefyx Sling System
- Solyx Sling System
- Lynx Sling System
Transvaginal mesh is a type of surgical mesh. It is implanted to help repair Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI). POP occurs organs protrude into the vagina due to weakened pelvic muscles. SUI occurs when weakened pelvic muscles allow the urethra to open when a woman coughs, sneezes, or laughs. Both POP and SUI are common complications of pregnancy. Hundreds of thousands of women have been implanted with transvaginal mesh to repair these ailments.
Boston Scientific Vaginal Mesh Recall
Boston Scientific is the company responsible for producing the first transvaginal mesh devices, back in the 1990s. Unfortunately, its first device, the ProteGen Vaginal Sling, had to be recalled due to safety concerns. Several newer brands of vaginal mesh have based their design on this recalled device.
A second Boston Scientific vaginal mesh recall occurred in 2011. The FDA recalled the Boston Scientific Pinnacle Pelvic Repair Kits on August 3, 2011. The FDA was concerned that “the device may exhibit low tensile strength between the needle and suture and lead to needle detachment during mesh leg placement.” The detachment of a needle could potentially lead to the perforation of nearby tissues or organs.
Vaginal Mesh and the FDA
The FDA has issued several public safety communications regarding vaginal mesh products. The first was issued in 2008, after the FDA received more than one thousand reports from women who had been seriously injured by the devices. The most common complication was erosion of the mesh into the vaginal wall. Organ perforation was another common complication.
The FDA’s second public safety communication was published in July 2011. The FDA had received nearly 3,000 more reports of injury, and they warned that serious complications were “not rare.” They advised doctors and patients to carefully weigh the risk-benefit of vaginal mesh, and consider alternatives.
The FDA is facing intense criticism over the way that the vaginal mesh devices were approved. Most of the devices gained FDA approval via the 510(k) process, which allows new products that are “substantially similar” to existing approved devices to submit applications without first conducting safety studies. The “similar” devices were a product made by Boston Scientific that was recalled in the 1990s due to safety concerns. Only after hundreds of thousands of women were implanted with various vaginal mesh devices did researchers become aware of the risk of complications.
Boston Scientific Vaginal Mesh Side Effects
The following side effects have been associated with Boston Scientific vaginal mesh devices:
- Life-threatening infection
- Erosion of the mesh into the vaginal wall
- Chronic pain, which can interfere with sexual intercourse
- Perforation of internal organs, bladder, intestines, blood vessels
- Return of Pelvic Organ Prolapse (POP) or Stress Urinary Incontinence (SUI)
- Vaginal bleeding
- Nerve Damage
- Shortening or disfigurement of the vagina
When women suffer from these complications, they often must undergo an additional surgery to remove the defective device, repair damage, or replace the mesh. Unfortunately, some long-term complications cannot be repaired, and they cause long-lasting damage that significantly decreases a woman’s quality of life.
Long-term complications may include psychological distress, loss of ability to have sexual intercourse without pain, lost wages, and expensive out-of-pocket medical bills.
Boston Scientific Vaginal Mesh Lawsuit
If you have a Boston Scientific vaginal mesh lawsuit, you are not alone. Currently, there are more than one thousand vaginal mesh lawsuits pending in federal courts against four different manufacturers of these devices. Boston Scientific faces at least 183 vaginal mesh lawsuits in a federal Multidistrict Litigation (MDL). The first bellwether trial is set for February 2013 in the U.S. District Court for the Southern District of Virginia.
If you were injured by Boston Scientific vaginal mesh, you may still have time to file a vaginal mesh lawsuit. You may be entitled to significant compensation for your pain and suffering, past and future medical expenses, decreased quality of life, lost income, and more.
Do I have a Boston Scientific Vaginal Mesh Lawsuit?
The Schmidt Firm, PLLC is currently accepting Boston Scientific vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by Boston Scientific vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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