The FDA first approved Boston Scientific vaginal mesh devices in 1996. Thousands of women across the United States suffer severe complications and injuries after surgery caused by Boston Scientific mesh or bladder sling systems. There are several Transvaginal mesh products manufactured by Boston Scientific. Product liability cases are being reviewed for women who may have received pelvic mesh or bladder sling product manufactured by Boston Scientific. Boston Scientific is the company responsible for producing the first transvaginal mesh devices, back in the 1990s. The FDA first approved Boston Scientific vaginal mesh devices in 1996.
Transvaginal mesh products made by Boston Scientific include:
- Anterior-Apical Pelvic Floor Repair Kit
- Posterior Pelvic Floor Repair Kit
- Duet Pelvic Floor Repair Kit
- Boston Scientific Uphold Vaginal Support System
- Boston Scientific Obtryx Transobturator Mid-Urethral Sling System
- Boston Scientific Advantage Transvaginal Mid-Urethral Sling System
On July 13, 2011 the FDA issued a Safety Communication update stating that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare. Thousands of women who were treated for pelvic organ prolapse or stress urinary incontinence with Boston Scientific vaginal mesh have suffered severe pain and significant injury. Boston Scientific Vaginal Mesh products associated with severe complications including life-threatening infection, chronic pain, which can interfere with sexual intercourse, erosion of the mesh into the vaginal wall, return of pelvic organ prolapse (POP) or stress urinary incontinence (SUI), perforation of internal organs, bladder, intestines, blood vessels, vaginal bleeding and shortening or disfigurement of the vagina.
Over two years prior the primary Boston Scientific transvaginal mesh trial brought about a decision supporting the manufacturer. In July 2014, a Massachusetts jury found that the company’s Pinnacle Vaginal mesh implant was properly designed and that Boston Scientific had warned plaintiff Diane Albright about the device risks. Just three months after the verdict the FDA issued two proposed orders that would reclassify TVM for pelvic organ prolapse as a high-risk device and require manufacturers to apply for premarket approval. The agency claims that with the exposure to greater risk comes no indication of greater clinical benefit in women electing to undergo pelvic organ prolapse repair surgery transvaginally.
According to plaintiff, Diane Albright statement the transvaginal mesh was implanted in 2010 in her body to treat a cystocele, which is a medical condition that occurs when the tough fibrous wall between a woman’s bladder and her vagina is torn by childbirth, allowing the bladder to herniate into the vagina. In her lawsuit documents Albright stated that the Pinnacle caused her intolerable pain and other severe complications and she claim that the manufacturers of transvaginal mesh failed to warn patients and doctors about this increased risk of the Pinnacle kit’s allegedly defective design before surgery. The decision by the FDA to reclassify the transvaginal mesh products as “high risk products” is a confirmation of the inherent danger of these products.
The plaintiff was not satisfied with the decision and appealed the court’s judgment. According to court documents seen by Mass Device the plaintiff’s attorney explained to the jury that the Pinnacle Pelvic Floor Repair Kit is made up of plastic, which is too large and heavy to be implanted safely and unsuitable for permanent implantation. Judge Gary Katzmann of Middlesex County Superior Court wrote in the opinion that the material warning on the device is “relevant, material evidence for the limited purpose of showing that (Boston Scientific), which has received the (warning) well before 2009, had notice or knowledge of the caution.”
Day before Yesterday the Massachusetts Appeals Court agreed, and sent back the case for reconsideration because the jury should have been allowed to see the MSDS (Material Safety Data Sheet) warning and the FDA letters. The lawsuit of Diane Albright against Boston Scientific Corp. is filed under the case number MICV2012-00909. More than 14,000 lawsuits filed against Boston Scientific consolidated for pretrial proceedings in US District Court before Judge Goodwin. Unfortunately, thousands of women have been seriously injured when their implant eroded into their vagina, perforated organs, caused chronic pain, or required revision surgery.
If you or somebody you know was injured or suffered complications or death from any Transvaginal mesh product or Bladder sling lawsuit, you should contact Drugsclaim.com for a free case consultation. The individuals may be able to seek compensation for medical bills, pain and suffering and other damages resulting from their mesh problems. All cases are pursued on a contingency fee basis there are never any out-of-pocket costs to hire our Cook filter attorneys unless we win your case. The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiff Lawsuit.