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Bladder Sling Lawsuits

Update Spring 2023 – We are accepting bladder sling and pelvic mesh removal/revision cases.

Multi-Million Dollar Bladder Sling Verdicts 

Bladder sling lawsuits are filed for women suffering from pain, nerve damage, UTIs, erosion and other complications resulting in sling removal surgery. Also known as bladder tacks, bladder tape, TVTs, TOTs, midurethral slings, transobturator or retropubic slings and mini-slings, are strips of synthetic mesh implanted to treat stress urinary incontinence (SUI). The slings act as a hammock to support the urethra which carries the urine from the bladder. Implants made from polypropylene have had serious complications reported in some women. Litigation over the past decade has resulted in billions of dollars in jury verdicts and settlements for women injured by bladder sling and pelvic mesh implants. For further information, click the video link to view the medical legal animation in the podcast: Failed Transvaginal Mesh Injury Lawsuit Podcast.

Bladder Sling and Pelvic Mesh Verdicts and Settlements for Women

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 subject to appeal and greatly reduced, remanded, or retried and most cases are settled for amounts 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

Complications Reported

In 2019, the FDA stopped the sale of some types of pelvic mesh products to treat pelvic organ prolapse (POP). Many manufacturers still sell bladder slings and other transvaginal mesh products to treat stress urinary incontinence (SUI) in women. Since 2011, over 100,000 claims were filed for women suffering from injuries associated with transvaginal bladder slings and pelvic organ prolapse mesh products.

What Injuries Are Associated with Transvaginal Mesh?

  • Vaginal, genital or rectal​area ​burning, tingling, numbness, stabbing or aching pain
  • Feeling that there is a lump or golf ball in the vagina or rectum
  • Hypersensitivity to touch, ​​pain or tenderness​along the pelvic nerve​s​
  • Painful bowel movement, muscle spasms, straining, constipation, or burning in the rectal area
  • Feeling the need to urinate when the bladder is empty
  • Urethral burning with/after urination, must push to urinate, or difficulty passing urine
  • Pain during or after intercourse or loss of sensation
  • Numbness, coldness or sizzling sensation in legs, feet, or buttocks
  • Chronic urinary infections or itching
  • Fallen or prolapsed bladder, uterus or rectum
  • Vaginal scarring, thickening

What Treatments Help Transvaginal Mesh Injuries?

    • Surgery for Removal of the Mesh/Sling
    • Surgery for Revision of the Mesh/Sling
    • Catheterization for over one week
    • Medications for pain or depression
    • Nerve Block Injections to reduce inflammation and allow the nerve to glide freely
    • Physical Therapy (PT) or Manual Therapy of pelvic floor muscles
    • Botox Injections into pelvic muscles may help to relax the muscles for 3-6 months
    • Insertion of Interstim device or bladder pacemaker
    • Neurostimulation of the pelvic floor
    • Surgery to decompress the pudendal nerve
    • Pulsed Radio Frequency Ablation
    • Pain Pump or Ketamine infusion
    • Bulking agents
    • Pessary insertion
    • Acupuncture

 What Is Stress Urinary Incontinence (SUI)?

Stress Urinary Incontinence (SUI) or bladder control loss, can range from mild leakage to uncontrollable urine loss. Causes include: childbirth, aging, obesity, surgery involving the bladder or vagina in women, medications, diabetes, neurologic conditions, multiple sclerosis, Parkinson’s disease, stroke and spinal cord injury and other reasons.

Diagnosing urinary incontinence tests might include: Urinalysis, bladder function tests, cystoscopy, cystogram, x-rays using dye to reveal urinary tract problems and ultrasound.
Urinary incontinence treatment may include: Botox injections, pessaries, pelvic floor physical therapy, medications, urethral bulking agent to reduce the opening of the urethra to prevent urine leakage, surgical sling procedure using body tissue or synthetic material to create a “sling or hammock” to keep the urethra closed and prevent urine leakage.
Surgical sling procedure: the surgeon uses strips of synthetic mesh, your own tissue, or sometimes animal or donor tissue to create a sling; under the tube that carries urine from the bladder (urethra) or the area of thickened muscle where the bladder connects to the urethra (bladder neck). The sling supports the urethra and helps keep it closed so that you do not leak urine.
Tension-free sling – No stitches are used to attach the tension-free sling, which is made from a strip of synthetic mesh tape. Instead, body tissue holds the sling in place. Eventually scar tissue forms in and around the mesh to keep it from moving. For a tension-free sling procedure, the surgeon may use one of three approaches:
Retropubic. A small incision inside the vagina just under the urethra is made. with two small
openings above the pubic bone. The surgeon uses a needle to pass the sling under the urethra and up behind the pubic bone. Absorbable stitches close the vaginal incision, and the needle sites may be sealed with glue or stitches.
Transobturator. A small incision inside the vagina just under the urethra is made, with a small
opening on each side of the labia. The sling passes a different pathway from the retropubic approach, but it is still placed under the urethra. Absorbable stitches close the vaginal incision and the needle site with glue or stitches.
Single-incision mini. One small incision in the vagina is made. The surgeon places the sling similar to the retropubic and transobturator approaches. No other incisions or needle sites are needed.
Conventional Sling. An incision in the vagina is made and a sling made of synthetic mesh tape is placed under the neck of the bladder. Through another incision in the abdomen, the surgeon pulls the sling to achieve the right amount of tension and attaches each end of the sling to pelvic tissue or the abdominal wall using stitches. Serious complications occur in some women, including erosion of the material, infection, organ perforation, pudendal neuralgia and other injuries causing pain and suffering. We are not medical professionals examining your body. Therefore, it is always recommended that you contact your health care provider, conduct your own research and use your own due diligence.

Contact Us Now

For medical legal questions, call the surgical nurse attorney at 1-800-814-4540 or email us at carolyn@carolynstclair.com if you have been injured by a bladder sling surgery. Our consultations are free and confidential. There are time limits in each state and hospitals destroy medical records after a certain time frame, so contact us now to preserve your rights.

 Sling procedures

Several types of operative techniques and approaches are noted in the medical records for sling procedures, including:

  • Tension-free vaginal tape sling (TVT)
  • Retropubic sling
  • Transobturator tape sling (TOT)
  • Single-incision mini sling
  • Conventional sling
  • Midurethral sling (MUS)

Pelvic Mesh Ordered Off the Market

On April 16, 2019, the FDA ordered the manufacturers of certain pelvic synthetic surgical mesh products to stop selling and distributing their products in the United States.   Additional information for patients and health care providers about the use of surgical mesh for transvaginal pelvic organ prolapse is provided in the links. Types of pelvic mesh products implanted and may still be on the market include:

Caldera Medical

  • Desara
  • Vertessa
  • Vertessa Lite

Ethicon

  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Obturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo

Bard

  • Align
  • Avaulta Plus™ BioSynthetic Support System
  • Avaulta Solo™ Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex™ Polypropylene Mesh
  • PelviLace
  • InnerLace
  • Uretex

American Medical Systems 

  • SPARC®
  • Mini-Arc
  • Apogee
  • Elevate
  • Monarc
  • In-Fast
  • BioArc

Boston Scientific

  • Obtryx® Curved Single
  • Obtryx® Mesh Sling
  • Obtryx Transobturator Mid-Urethral Sling System
  • Prefyx Mid U™ Mesh Sling System
  • Prefyx PPS™ System
  • Uphold Vaginal Support System
  • Pinnacle Pelvic Floor Repair Kit
  • Advantage Transvaginal Mid-Urethral Sling System
  • Advantage Fit System
  • Solyx SIS System

Coloplast

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

FDA Warnings You SHOULD Know About

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 POP mesh use. Subsequently, the FDA issued 131 orders to conduct post market surveillance studies (“522 orders”) to 34 manufacturers of mesh for transvaginal repair of POP. Most manufacturers elected to stop marketing surgical mesh for transvaginal repair of POP.

January 2016: The FDA reclassified surgical mesh for transvaginal repair of POP into the highest risk class of devices (class III), which requires premarket approval (PMA) applications in order to stay on the market.

July 5, 2018: Deadline for applications to be filed for premarket approval for any mesh marketed for transvaginal POP repair. Manufacturers that did not file PMAs were required to withdraw their products from the market.

February 12, 2019: The FDA convened an advisory committee meeting to seek expert opinions on how to evaluate the risks and benefits of the POP mesh devices placed transvaginally in the anterior vaginal compartment. 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.  FDA experts 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 did not approve Pelvic Organ Prolapse devices.

August 16, 2021: Boston Scientific and Coloplast devices for transvaginal repair of pelvic organ prolapse are no longer commercially available. However, the FDA required the manufacturers to continue follow-up of the subjects already enrolled in their postmarket surveillance studies (“522 studies”), which looked at effectiveness and safety of transvaginal mesh for POP as compared to transvaginal native tissue repair (repairs without the use of mesh).

The two Boston Scientific 522 studies were completed, and showed that Boston Scientific transvaginal POP mesh had similar effectiveness and safety outcomes to native tissue repair at 36 months. The FDA continues to believe that devices of this type for transvaginal POP mesh repair presents potential additional risks compared to native tissue repair, including mesh exposure and erosion. Therefore, the FDA maintains that these POP devices do not have a favorable benefit-risk profile.

Multi District Litigation

The multi district litigation (MDL) courts have been dismantled as of 2018. However, bladder sling and pelvic mesh removal cases are now being filed in individual courts across the nation.  These TVM MDL courts are closed to new cases:

MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation

MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation –

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation

MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation

MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation

Contact Us Now

Call us at 1-800-814-4540 or email carolyn@carolynstclair.com if you have had injuries from your bladder sling surgery. Our consultations are free and confidential. There are time limits in each state and hospitals destroy medical records after a certain time frame, so contact us now to preserve your rights.

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