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Transvaginal Mesh

vaginal meshTransvaginal mesh was once viewed as the gold standard for treating posterior vaginal wall prolapse and urinary incontinence in women. The use of mesh systems expanded from hernia repair operations to organ prolapse and incontinence in the 1970s. The first ready-to-use kits widely marketed to gynecologists and urologists came about in 2004, enabling doctors with relatively little experience in abdominal surgery to treat patients with weakened tissue.

Each year, over 200,000 women undergo surgery to permanently implant polypropylene mesh in the body to hold the uterus, vagina, rectum, or bladder and urethra in place, according to a report published in the American Journal of Obstetrics and Gynecology. However, a 2009 review published in the International Urogynecology Journal cited a vaginal mesh failure rate of up to 25 percent, with cigarette smoking increasing the risk of mesh erosion threefold.

Why does transvaginal mesh fail?

Bloomberg reports that many of the mesh products on the market were passed using the FDA’s 510(k) clearance program, which alleviates the need for extensive clinical research prior to approval, and based on the Boston Scientific’s ProteGen Sling, a product that was recalled in 1999.

Surgeons told WBUR Radio that mesh contamination is all too easy, given that the vagina’s normal flora includes Staph and E.coli bacteria, which cannot be surgically cleansed from the operative field.

Complications that occur as a result of mesh erosion include:

  • Protrusion of mesh from the vagina
  • Bleeding
  • Constant pelvic pain
  • Infection and discharge
  • Painful intercourse
  • Organ perforation
  • Urinary problems
  • Vaginal scarring
  • Vaginal shrinkage
  • Neuro-muscular problems
  • Emotional issues like anxiety and depression

Removing the mesh through revision surgery is equally problematic. According to Bay Area pelvic surgeon, Dr. Michael Thomas Margolis, removal is like “taking a hammer and chisel and trying to remove the rebar from a sidewalk while leaving the cement otherwise intact and not damaging the water mains and power lines below.” In other words: “It is difficult if not impossible to remove all the mesh and do it safely.”

FDA warnings

In October 2008, the FDA issued their first public health alert, stating that there were “serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.”

They updated their alert in July to include their findings that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and indicated that mesh treatment “may expose patients to greater risk” than traditional methods of repair. The agency cited 3,979 reports of adverse events spanning from January 2005 to December 2010.

While these announcements may help future patients, the hundreds of thousands of women who have already been affected are left with little recourse other than to sue for damages in court.

Multi-District litigation

Federal litigation against transvaginal mesh manufacturers has been consolidated in West Virginia under U.S. District Judge Joseph R. Goodwin. Some of the cases have been settled, but many are still unresolved. As of May 15, 2015:

  • 320 of 11,083 cases have been resolved for C.R. Bard pelvic repair system products under MDL 2187.
  • 854 of 19,708 cases have been resolved for American Medical Systems products under MDL 2325.
  • 291 of 16,716 cases have been resolved for Boston Scientific Corp. products under MDL 2326.
  • 686 of 25,710 cases have been resolved for Ethicon Inc. products under MDL 2327.
  • 146 of 2,081 cases have been resolved for Coloplast Corp. products under MDL 2387.
  • 45 of 344 cases have been resolved for Cook Medical Inc. products under MDL 2440.
  • 19 of 105 cases have been resolved for Neomedic products under MDL 2511.

In addition to these federal cases, there are a number of transvaginal mesh lawsuits individually filed in state courts still pending as well.

Jury awards

There have been big wins for many of the plaintiffs whose cases have gone to court so far:

Boston Scientific

  • In May 2015, a Delaware jury ordered Boston Scientific to pay $100 million to a 51-year-old Newark woman who received a mesh product to treat incontinence and sagging pelvic organs only to suffer painful intercourse and urinary tract infections. Despite two surgeries, pieces of the mesh remain painfully embedded inside her, according to The News Journal.
  • In September 2014, a Texas jury voted in favor of the plaintiff, forcing Boston Scientific to pay out $73 million to a woman who suffered permanent nerve damage and constant pelvic pain from defective mesh used to treat urinary incontinence.
  • In November 2014, Boston Scientific paid four women a total of $18.5 million after West Virginia jurors determined the company did not do enough to warn of known risks associated with their product. A similar verdict came out of Miami, with a total settlement of $26.7 million paid to four women.

Ethicon

  • Several weeks prior to the Texas case, a West Virginia jury awarded a woman implanted with an Ethicon device $3.27 million, following another federal trial held earlier in the year where the defendant won. According to Reuters, “Juries in New Jersey and Texas previously awarded women suing Ethicon $11 million and $1.2 million, respectively.”
  • In September 2014, a federal jury in West Virginia ordered Ethicon to pay $3.27 million for causing a woman’s permanent injuries.
  • In 2013, a New Jersey jury returned an $11 million verdict against Ethicon for complications from the Gynecare Prolift mesh.

C.R. Bard

  • Furthermore, R. Bard was ordered to pay a victim $2 million in their first federal trial for transvaginal mesh failure.
  • A California jury returned a $5.5 million verdict concluding Bard’s negligence in a woman’s vaginal mesh case.

Not surprisingly, companies like American Medical Systems agreed to settlements early on, before any trials debuted in court, to mitigate some of the legal expenses associated with such sizable litigation.

Transvaginal mesh settlements

Some attorneys feel the transvaginal mesh injuries have resulted in a “national public health disaster,” especially considering the proposed settlements may only cover a fraction of the pending lawsuits.

A summary of the vaginal mesh settlement proposals includes:

  • A $16 million settlement proposed by Coloplast to resolve about 400 suits.
  • A $21 million settlement proposed by C.R. Bard to resolve over 500 lawsuits, which would pay out just over $43,000 per claim.
  • A $119 million settlement proposed by Boston Scientific to settle nearly 3,000 (of the 22,000+ pending lawsuits filed in federal and state courts.)
  • A $830 million settlement proposed by Endo International, the manufacturer of American Medical Systems mesh, to settle “substantially all” of the cases pending against them.
  • An undisclosed settlement proposed by Johnson & Johnson’s Ethicon division to settle just four of the thousands of pending lawsuits.

More settlements are anticipated as the evidence stacks up against manufacturers of the flawed mesh products. Victims who have been affected by complications from their vaginal mesh can inquire about getting involved with the ongoing settlement talks by speaking with one of the many qualified attorneys specializing in transvaginal mesh lawsuits.


  1. JPML – Pending Dockets, http://www.jpml.uscourts.gov/pending-mdls-0

  2. The News Journal - Del. woman wins $100 million in transvaginal mesh case, http://www.delawareonline.com/story/news/local/2015/05/28/delaware-woman-awarded-transvaginal-mesh-case/28090847/

  3. Reuters - Boston Scientific ordered to pay $73 million over mesh device, http://www.reuters.com/article/2014/09/09/bostonscientific-mesh-verdict-idUSL1N0RA2BB20140909

  4. Bloomberg - Boston Scientific Vaginal-Mesh Victims Win $18.5 Million, http://www.bloomberg.com/news/articles/2014-11-20/boston-scientific-vaginal-mesh-victims-win-18-5-million

  5. LA Times - Johnson & Johnson to settle four cases over vaginal-mesh implants, http://www.latimes.com/business/la-fi-jnj-vaginal-mesh-20150122-story.html

  6. American Journal of Obstetrics and Gynecology - Procedures for pelvic organ prolapse in the United States, 1979-1997, http://www.ncbi.nlm.nih.gov/pubmed?term=12548203

  7. FDA - FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, http://www.fda.gov/medicaldevices/safety/alertsandnotices/publichealthnotifications/ucm061976.htm

  8. WBUR - Surgery Under Scrutiny: What Went Wrong With Vaginal Mesh, http://commonhealth.wbur.org/2011/11/surgery-under-scrutiny-what-went-wrong-with-vaginal-mesh/

  9. Bloomberg - Coloplast Said to Pay $16 Million to Settle Mesh Lawsuits, http://www.bloomberg.com/news/articles/2014-03-04/coloplast-said-to-pay-16-million-to-settle-mesh-lawsuits

  10. Bloomberg - Bard Said to Pay $21 Million in First Big Mesh Accord, http://www.bloomberg.com/news/articles/2014-10-07/bard-said-to-pay-21-million-in-first-big-vaginal-mesh-accord