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Coloplast Bladder Mesh Lawsuit Update

March 2025: We are accepting bladder mesh revision cases.

Coloplast bladder mesh lawsuits are filed for injured women in 2025 and we are accepting cases removal/revision cases. Since 2011, when the pelvic mesh litigation began, we have successfully prosecuted cases for women implanted with transvaginal mesh products that have been surgically removed or revised. The FDA told Coloplast and other manufacturers to stop selling Pelvic Organ Prolapse mesh devices in 2019 after a 36 month study. Women can have bladder slings and pelvic mesh implanted and experience severe complications years later requiring surgical removal or revision. In April 2022, a Florida jury delivered a $2.5 million verdict against Coloplast for a woman injuried by a pelvic mesh product.

Major medical clinics and university-affiliated medical institutions have published about sling and pelvic mesh complications and treatments, as follows:

  1. Cleveland Clinic:  Mesh Problems and Complications
  2. University of Texas – Southwestern Medical Center: FDA Ban on Transvaginal Mesh
  3. University of Miami Health: Mesh Complications

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.

Coloplast Bladder Sling and Pelvic Mesh Products

Coloplast pelvic mesh and bladder sling products that required surgical revision or removal include:

  • Altis Transobturator Sling
  • Aris Transobturator Sling System
  • Restorelle Y-Mesh
  • Supris Suprapubic Sling System
  • Novasilk Synthetic Flat Mesh
  • Suspend-Tutoplast Processed Fascia Lata
  • Exair-Prolapse Repair System
  • Axis-Tutoplast Processed Dermis
  • Smartmesh
  • Omnisure
  • Minitape

Women plaintiffs implanted with bladder sling and pelvic mesh products claim that the vaginal mesh devices cause serious injuries, 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
  • Infections
  • Bleeding
  • Reoccurrence
  • Emotional issues
  • Chronic pain
  • Fistulas
  • Organ perforation
  • Incontinence
  • Pelvic nerve damage

Pelvic Mesh Verdicts

Since the Transvaginal Mesh litigation began, there were many jury verdicts for women. Note that verdicts are often appealed by the losing parties and are remanded, reversed, reduced or settled for much lesser amounts. However, the plaintiffs’ verdicts illustrate the successes women have had in this litigation. Verdict and settlements over the past 13 years include:

  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 (09 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
  44. 5/23:   0 – Dandy v. Ethicon/JJ (TVT-O) – NJ

Are There Other Treatments for SUI?

For many decades, autologous fascial slings provide a polypropylene mesh-free alternative to treat stress urinary incontinence. Yet, many patients are never given that option when discussing the bladder sling surgery. Dr. Ariana Smith, Director of Pelvic Medicine and Reconstructive Surgery at Pennsylvania University Hospital discusses the differences and makes a comparison of pubovaginal slings in the video in UroToday. Dr. Smith emphasizes the importance of offering both mesh and autologous options when considering surgery.

FDA Warnings

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 Coloplast implants – Altis Sling, Aris Sling, Supris Sling, Novasilk mesh, Tutoplast, Exair, Axis Tutoplast, Restorelle, Smartmesh, Omnisure or Minitape – implanted and are still indwelling. Many ladies may experience complications and their surgeons may advise to have the implant surgically removed or revised.

Free Medical Legal Consultation

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. We have been practicing medical product liability law for over three decades and are here to help you.

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