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Pelvic Mesh Lawsuits

Pelvic mesh, also known as transvaginal mesh, are patches of synthetic mesh implanted to treat pelvic organ prolapse (POP).  Pelvic mesh made from polypropylene has 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 sling and pelvic mesh implants.

Complications Reported

In 2019, the FDA stopped the sale of some types of pelvic mesh products to treat pelvic organ prolapse (POP). However, many manufacturers still sell pelvic mesh and bladder slings and other transvaginal mesh products to treat pelvic organ prolapse and stress urinary incontinence (SUI) in women.  Complaints associated with transvaginal mesh devices include:

  • chronic pelvic pain
  • urinary problems and/or incontinence
  • pain during sexual intercourse
  • recurrence of prolapsed bladder or uterus
  • infection and abscess
  • aching, burning or stabbing pain in the pudendal nerve area
  • pelvic bleeding

These symptoms have been linked to complications of the mesh, including:

  • bowel, bladder, and blood vessel perforation
  • pelvic floor damage
  • pudendal nerve damage
  • mesh erosion or extrusion through the vaginal tissue
  • mesh contracture or shrinkage
  • chronic inflammation
  • fistula creation
  • internal scar tissue formation

Treatment of complications includes additional surgical procedures to revise or remove the mesh and slings, decompress the pudendal nerve, repair of  fistulas and damage to other pelvic organs and nerves. Other treatment includes drainage of hematomas and abscesses from infection, medication, pain injections, Botox injections, pulsed radio frequency ablation, Ketamine infusion, bulking agents, electrode therapy, physical pelvic therapy, pessary insertion to alleviate the pain and dysfunction associated with pelvic mesh complications.

Pelvic Mesh Products

Johnson & Johnson/Ethicon

Gynecare TVT, Abbrevo, Exact, Secur, Prolift, Prosima

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  • Retropubic Sling
  • Mid Urethral Sling
  • Exact TVT
  • Gynecare Abbrevo TVT
  • Gynemesh

Ethicon Products no longer on the market

  • Gynecare Abbrevo TVT
  • Gynemesh PS
  • Prolene Polypropylene Mesh Patch
  • Exact
  • Secur
  • Prolift+
  • Prolift +M
  • Prosima

American Medical Systems (AMS)

Sparc, Mini-Arc, Monarc, Apogee, Elevate, Perigee

AMS products no longer on the market

  • SPARC
  • Mini-Arc
  • Monarc
  • Apogee
  • Elevate
  • Perigee

Bard

Avaulta, Align, Pelvicol, Pelvitex

Bard Products no longer on the market

  • Avaulta PlusTM
  • BioSynthetic Support System
  • Avaulta Solo Synthetic Support System
  • Faslata® Allograft
  • Pelvicol® Tissue
  • PelviSoft® Biomesh
  • Pelvitex Polypropylene Mesh

Boston Scientific

Advantage, Obtryx, Solyx, Lynx, Uphold, Pinnacle, Prefix

  • Advantage™ Mid-Urethral Sling System
  • Obtryx® Transobturator Mid-Urethral Sling System
  • Solyx

Boston Scientific Products no longer on the market

  • 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

Coloplast

Altis, Aris, Supris, Retorelle Y Mesh

  • Altis
  • Aris
  • Supris
  • Restorelle Y Mesh
  • Restorelle Flat Mesh
  • Restorelle L Mesh

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What Is Pelvic Organ Prolapse (POP)?

A woman’s pelvic organs, including the uterus, bladder and rectum, can slip and create a bulge in the vagina after the muscles, tissues and ligaments supporting those organs weaken. Causes include: childbirth, hysterectomy, menopause, heavy lifting chronic coughing, constipation, obesity, previous pelvic surgery, neurological conditions or injuries.

Classification of Pelvic Organ Prolapse

  • Cystocele – also known as bladder prolapse, is one of the most common types of pelvic organ prolapse. A bulge or dropping of the anterior vaginal wall causes the bladder to slip into the bulge
  • Urethrocele – the female urethra slips in the vagina
  • Uterine prolapse – the uterus slips in the vagina
  • Vaginal prolapse – the vaginal walls begin to drop and cause vagina to turn inside out
  • Vaginal vault prolapse – the vagina’s upper portion slips in the vaginal canal or outside the vagina
  • Rectal prolapse – the rectum turns inside out and protrudes through the anus
  • Enterocele – the small intestines bulge between the uterus and rectum or bulge on the top of the vagina
  • Rectocele – the rectum bulges into the posterior vaginal wall

Types of Reconstructive Surgery with Mesh or Slings

  • Colporrhaphy—Used to treat prolapse of the anterior (front) wall of the vagina and prolapse of the posterior (back) wall of the vagina. This type of surgery is performed through the vagina. Stitches are used to strengthen the vagina so that it once again supports the bladder or the rectum.
  • Sacrocolpopexy—Used to treat vaginal vault prolapse and enterocele. It can be done with an abdominal incision or with laparoscopy. Surgical mesh is attached to the front and back walls of the vagina and then to the sacrum (tail bone). This lifts the vagina back into place.
  • Sacrohysteropexy—Used to treat uterine prolapse when a woman does not want a hysterectomy. Surgical mesh is attached to the cervix and then to the sacrum, lifting the uterus back into place.
  • Vaginally placed mesh—Used to treat all types of prolapse. Can be used in women whose own tissues are not strong enough for native tissue repair. Vaginally placed mesh has a significant risk of severe complications, including mesh erosion, pain, infection, and bladder or bowel injury. This type of surgery should be reserved for women in whom the benefits may justify the risks.Symptoms Include:
    • A bulge outside the vagina
    • Urination difficulty or frequent need to urinate
    • Constipation or difficulty having a bowel movement
    • Sensation of something falling out of the vagina
    • Stress Urinary Incontinence
    • Discomfort or pain in the vagina, pelvis, groin or lower abdomen or back
    • Tender or bleeding tissue protruding from the vagina
    • Painful intercourse

Contact Us Now

For legal questions, call us 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.  We can obtain and review medical records to determine the type of bladder sling procedure performed. For further in depth information, click the video link to review medical legal animation in the podcast: Failed Transvaginal Mesh Injury Lawsuit Podcast.

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 and sling products implanted and may still be on the market include:

Ethicon

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

C. R. Bard

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

American Medical Systems (AMS)

  • 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

Cook 

  • Surgisis

Neomedic

TVM Verdicts and Settlements

Verdicts, settlements, manufacturers, products, and jurisdictions over the past decade follow:

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

Multi District Litigation

The multi district litigation (MDL) courts have been dismantled as of 2018. Cases are now being filed in individual courts across the nation.  These 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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