Published By: Maxwell S. Kennerly, Esquire

 

This page is part of the vaginal mesh erosion section of this website.

 

This page answers frequently asked questions about the complications and side effects of the Johnson & Johnson / Ethicon line of transvaginal mesh products, including the Prolift, Gynemesh Prolene, TVT Sling, and TVT-O implants, including:

 

  • What happened?
  • What has the FDA done?
  • Which vaginal mesh products are affected?
  • Who might have a claim?
  • Which mesh lawyers run this website?
  • What scientific studies have been done to determine the safety of Gynecare vaginal mesh?

 

What happened?

 

Medical studies have shown that the vaginal mesh (sometimes called “tape” or a “sling”) used by surgeons and gynecologists to repair pelvic organ prolapse like cystocele or urethrocele has a much higher rate of serious complications than previously claimed by the mesh manufacturers.

The discovery has caused over 2,000 transvaginal mesh patients with complications to file lawsuits against the manufacturers of the mesh, including Johnson & Johnson subsidiary Ethicon, which manufactured and sold the “Gynecare” line of products for treatment of pelvic organ prolapse and stress urinary incontinence, including the Gynecare Prolift Pelvic Floor Repair System, Gynemesh Prolene, Gynecare TVT, and Gynecare TVT Obturator System (“TVT-O”). As of mid-2012, more than 1,000 lawsuits are pending against Ethicon arising from mesh complications.

 

What has the FDA done?

 

On July 13, 2011 the FDA issued a Safety Communication update stating that “serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse are not rare.” Specifically, the FDA has identified the following common side effects of using surgical mesh to as an implant in the vaginal or pelvic region:

  • vaginal mesh erosion (also called exposure, extrusion or protrusion),
  • pain (including painful sexual intercourse known as dyspareunia),
  • infection,
  • urinary problems,
  • bleeding, and
  • organ perforation.

There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage and emotional problems.  Many of the medical device reports cited the need for additional intervention, including medical or surgical treatment and hospitalization.

The FDA is currently reviewing transvaginal mesh products, and in early 2012 requested the manufacturers of the mesh, including Ethicon, to provide more detailed information on the adverse events of which they are aware.

 

Which vaginal mesh products are affected?

 

Most reports have come from:

  • Gynecare, Gynemesh, or Ethicon (made by Johnson & Johnson);
  • Avaulta, Pelvicol, and Pelvisoft (made by C.R. Bard);
  • Advantage Sling, Obtryx, Perfyx, Pinnacle and others (made by Boston Scientific Products), and
  • Spar, Miniarc, Monarc, Apogee, Perigee, Elevate (made by American Medical Systems) meshes.

Any surgical mesh used to repair public organ prolapse or stress urinary incontinence is at a risk of erosion, failure, and the need for repair. All of the major Johnson & Johnson “Pelvic Floor Repair System” products have been implicated, including the Gynecare Prolift, Gynemesh Prolene, Gynecare TVT Sling, and Gynecare TVT-O.

 

Who might have a claim?

 

Every woman implanted with a transvaginal mesh might have a theoretical legal claim, but claims without serious damages — such as continuing severe symptoms, the recommendation for a revision or repair surgery, or hospitalization — are disfavored by courts and are typically not worth the expense and emotional burden of pursuing litigation. At our firm, we screen for cases in which the patient suffered either:

  1. Diagnosed organ damage due to adhesions to the bladder or urethra, or due  to perforations of the bowel. Interstitial cystitis and fistulas are common terms used by physicians. Often, if organ damage has occurred, the patient’s treating doctor will recommend mesh removal, replacement or repair surgery, and sometimes tissue reconstruction surgery.
  2. Ongoing severe symptoms such as:
  • the mesh eroding or sticking through the bladder, bowel or vagina,
  • unexplained infection or recurring infections,
  • pain during intercourse (“dyspareunia”)
  • vaginal scarring, or erosion or sloughing of vaginal tissue,
  • recurrence of vaginal prolapse, uterine prolapse, or,
  • urinary problems like incontinence.

Read more about vaginal mesh erosion symptoms.

We then screen to determine if medical malpractice may have been the cause of the problems. The vaginal mesh manufacturers have already started defending these mesh lawsuits by blaming the patient’s physicians and surgeons. Sometimes, the problems really were due to medical malpractice, and so we independently investigate the issue.

We look initially for when the problems began: if the patient had unexpected problems (like trouble urinating) within the first month of the implant, it is more likely the problems were caused by malpractice than by mesh erosion. If, instead, the problems began six months or later after the implant, then it makes it more likely that the mesh was the problem, not a negligent surgical installation. If the injuries appear to be caused by malpractice, then we will handle the case as a malpractice case rather than a defective medical device case.

If you fit the above criteria, or aren’t sure if you do, please use the form on the right to send me and email or call my office directly at (215) 948-2718 for a no-cost, confidential review of your claim.

 

Which mesh lawyers run this website?

 

I’m not a an actor on a television commercial or someone in a call center: I’m a real lawyer who has successfully tried serious injury and wrongful death cases in front of juries. If you use the contact form below, the email goes to me.

 

What scientific studies have been done to determine the safety of Gynecare vaginal mesh?

 

In addition to the extensive data reviewed by the FDA in reaching their conclusions, other studies have also found that transvaginal mesh to repair pelvic organ prolapse has a higher risk of serious complications. In “Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse,” which was partially funded by Ethicon, the researchers found “As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events.”

 

For a free, confidential review of your claim, use the contact form below or call my office directly at (215) 948-2718.

 

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