Boston Scientific Sling Update
Spring 2023 – We are accepting Boston Scientific sling and pelvic mesh removal/revision cases.
Boston Scientific sling and pelvic mesh lawsuits are filed for injured women after the FDA ordered some products off the market. The FDA found that some Boston Scientific mesh products are defective. In March 2021, Boston Scientific agreed to pay $189 Million to settle a multi-state lawsuit over the marketing of its surgical mesh devices. The settlement funds will be divided up among 47 states and Washington, D.C. that were all part of the lawsuit against the company. Part of the settlement includes an agreement from the company to “describe more accurately to consumers the safety and risks” of using surgical mesh as reported: Boston Scientific to Pay $189 Million in Vaginal Mesh Lawsuit.
Since pelvic mesh litigation began in 2011, we have successfully prosecuted cases for women implanted with transvaginal mesh products. For further information, click the video link to review the medical legal animation in the podcast: Failed Transvaginal Mesh Injury Lawsuit Podcast.
Boston Scientific Pelvic Mesh Verdicts
- 9/14: $73.465 million – Martha Salazar – Boston Scientific (Obtryx) – TX
- 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific (Pinnacle) – MDL FL
- 11/14: $6.7+ million – Margarita Dotres – Boston Scientific (Pinnacle) – MDL FL
- 11/14: $6.7+ million – Mania Nunez – Boston Scientific (Pinnacle) – MDL FL
- 11/14: $6.5+ million – Juana Betancourt – Boston Scientific (Pinnacle) – MDL FL
- 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific (Obtryx) – MDL WV
- 11/14: $4.75 million – Chris Wilson – Boston Scientific (Obtryx) – MDL
- 11/14: $4.25 million – Carol Campbell – Boston Scientific (Obtryx) – MDL
- 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific (Obtryx) – MDL
- 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
- 5/15: $100 million – Deborah Barda v. Boston Scientific (Pinnacle, Advantage Fit) – DL
Women plaintiffs implanted with bladder sling and pelvic mesh products claim that the vaginal mesh devices cause serious health issues, including:
- Vaginal mesh erosion: polypropylene mesh can break down, leaving the mesh exposed to protrude through the vagina.
- Erosion of mesh into other organs: polypropylene mesh may erode into the urethra, bladder or rectum.
- Vaginal mesh contraction: polypropylene mesh shortens and tightens to cause vaginal tissue pain.
- Pain during sexual intercourse
- Urinary problems
- Emotional issues
- Chronic pain
- Organ perforation
- Pelvic nerve damage
Pelvic mesh and bladder sling problems have been reported by major medical clinics for decades. Major medical clinics and university affiliated medical institutions, including the Cleveland Clinic, have published articles and treatise for your review at Mesh Problems and Complications.
Boston Scientific Implants
We are reviewing cases involving Boston Scientific pelvic mesh products that required surgical revision or removal including:
- Advantage™ Mid-Urethral Sling System
- Advantage Fit Sling
- Obtryx® Transobturator Mid-Urethral Sling
- The Prefyx PPS System
- The Solyx SIS System
- Lynx Suprapubic Mid-Urethral Sling
- Prefyx Mid UTM Mesh Sling System
- Prefyx PPSTM System
- Pinnacle® Anterior-Apical Pelvic Floor Repair Kit
- Pinnacle® Posterior Pelvic Floor Repair Kit
- Pinnacle® Duet Pelvic Floor Repair Kit
- The Uphold Vaginal Support System
Contact us now for a free medical legal consultation about your pelvic mesh product at 1-800-814-4540. There are deadlines in each state and hospitals destroy medical record evidence after a certain time period, so contact us now.
July 2011: An FDA Safety Communication identified concerns and issued new recommendations on surgical mesh for transvaginal repair of Pelvic Organ Prolapse (POP).
September 2011: The FDA convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of the mesh use. The FDA issued 131 orders to conduct post market surveillance studies (PMAs) to 34 manufacturers of surgical mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical mesh.
January 2016: The FDA completed its reclassification of surgical mesh for transvaginal repair of POP into the highest risk class of devices (class III), which requires premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to stay on the market.
July 5, 2018: Manufacturers that did not file PMAs for their POP mesh by this deadline had to withdraw their products from the market.
February 12, 2019: The FDA convened an advisory committee meeting to share the available evidence and seek expert opinions on how to evaluate the risks and benefits of these devices. Boston Scientific filed two PMAs for its devices, the Uphold LITE Vaginal Support System and the Xenform Soft Tissue Repair System. Coloplast filed a PMA for its device, Restorelle DirectFix Anterior.
In February 2019, the FDA convened a panel of experts and agreed with their recommendations, but the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.
Since 2019, some of the Boston Scientific mesh products had been removed from the market and are no longer being implanted in women. However, thousands of women still have the Boston Scientific products – Advantage™ Mid-Urethral Sling System, Obtryx® Transobturator Mid-Urethral Sling System, Solyx, Lynx, Prefyx Mid UTM Mesh Sling System, Prefyx PPSTM System, Pinnacle® Anterior-Apical Pelvic Floor Repair Kit, Pinnacle® Posterior Pelvic Floor Repair Kit, Pinnacle® Duet Pelvic Floor Repair Kit – Boston Scientific Uphold Vaginal Support System, Uphold – implanted and are still indwelling. Many ladies may experience complications and their surgeons may advise to have the implant surgically removed or revised.
Call us for your free medical legal consultation at 1-800-814-4540 or fill out the Contact Us Form and tell us about your claim.