Pelvic mesh lawsuits have been filed for women suffering from complication from the sling and mesh products. $1.6+ billion in settlements and $240+ million verdicts have been claimed for women since 2011.  While most verdicts are appealed and settle for much lower amounts, these awards show the successes women have in transvaginal mesh injury litigation. Some mesh and sling products still remain on the market and are being implanted in women. Major medical clinics and university affiliated medical institutions, such as the Cleveland Clinic, have published articles and treatise on  Mesh Problems and Complications

Transvaginal Mesh Verdicts

 

Most of these verdicts involved claimants with multiple complex surgeries resulting in numerous lifelong devastating injuries with juries awarding punitive damages. Note that jury verdicts are reversed, remanded, reduced or appealed by the losing parties and settled for amounts much less than the jury awards.

1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus – CA
2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O – TX
6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX  *
10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx – MDL WV
15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
18. 2/15: Settled – Wise v. Bard in the MDL
19. 3/15: Settled – Bellew v. Ethicon (Prolift) in the MDL
20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima – TX
24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) – PA
26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT) – PA
28. 4/17: $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
29. 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
30. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA
31. 3/18: $35 million – Kaiser v. Ethicon/JJ (Prolift) – IN
32. 4/18: $68 million – McGinnis v. Bard – NJ
33. 1/19: $41 million – Emmett v. Ethicon/JJ – PA
34. 4/19: $120 million – McFarland v. Ethicon/JJ – PA
35. 5/19: $80+ million – Mesigian v. Ethicon/JJ – PA
36. 6/19: $500,000 – Dunfee v. Ethicon/JJ (Prolift) – PA
37. 3/22: 0 – McBroom v. Ethicon/JJ (Prolift, TVT-Secur) – AZ
38. 3/22: 0 – Shears v. Ethicon/JJ (TVT) – WV
39. 4/22: $2.5 million – Redding v. Coloplast (Novasilk) – FL
40. 7/22: 0 – Burris v. Ethicon/JJ (Prolift, TVT-Secur) – OH
41. 10/22: 0 – Jarrett v. Ethicon/JJ (TVT-O) – AR
42. 10/22: 0 – Richards v. Ethicon/JJ (TVT-O) – TX
43. 12/22: 0 – Snowden v. Ethicon/JJ (Abbrevo) – TX

Pelvic Mesh Claims

From 2011 to the present, over 100,000 pelvic mesh claims of defective products causing injuries have been resolved. Settlements and verdicts involving multimillions have been made with many pelvic mesh products taken off the market. We are accepting cases of certain defective pelvic mesh products that have been surgically removed or revised.

   

 FDA Warnings You May Not Know About

In February 2019, the FDA convened an advisory panel of experts that recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months. The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.

July 2011: An FDA Safety Communication identified concerns and issued new recommendations about the use of surgical mesh for transvaginal repair of Pelvic Organ Prolapse (POP).

September 2011: FDA convened a public meeting of the Obstetrics and Gynecology Devices Panel to discuss the benefits and risks of this use. Subsequently, the FDA issued 131 orders to conduct post market surveillance studies (“522 orders”) to 34 manufacturers of surgical mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical meshfor transvaginal repair of POP after receiving their 522 orders.

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: This was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal POP repair. Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market. Those that did file PMAs were allowed to keep their mesh products on the market while the FDA reviewed their PMAs.

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. The committee evaluated mesh placed transvaginally in the anterior vaginal compartment, as well as identifying the appropriate patient population and physician training needed for 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 an advisory panel of experts that recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months. The FDA agreed with these recommendations, and because such data were not provided by manufacturers in their PMAs, the FDA decided not to approve Pelvic Organ Prolapse devices. Even though these products can no longer be used in patients moving forward, Boston Scientific and Coloplast are required to continue follow up of the subjects already enrolled in their 522 studies.