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Grim Outlook for Vaginal Mesh Makers as Looming Federal Trial Approaches

Surgical mesh has been used prolifically in the urogynecologic field to treat relatively common conditions like prolapsed pelvic organs and incontinence. In a typical procedure, surgical mesh is permanently implanted to reinforce a weakened vaginal wall, or to provide support to the urethra. Every year, more than 75,000 women undergo a procedure involving vaginal mesh. However, some say implanted vaginal mesh does patients more harm than good.

Although the use of surgical mesh in medical treatment goes back decades, it was not until 2002 that the FDA approved a vaginal mesh product specifically designed for repairs of pelvic organ prolapse. In the decade that followed, patient reports of complications became increasingly common. Now, the FDA has reclassified vaginal mesh products as high-risk, and one of the biggest lawsuits in recent memory against allegedly negligent medical product manufacturers is set to take the stage in federal court.

What Is Going Wrong With Vaginal Mesh Implants?

Patients who have been treated with vaginal mesh implants have reported a wide variety of complications. They include:

  • Erosion/protrusion of the mesh from soft tissues
  • Urinary tract problems
  • Infections
  • Bleeding from the mesh site
  • Pain, both ongoing and during intercourse
  • Damage to nearby organs

The rate at which these problems occur following the implantation of vaginal mesh is not well known. However, one of the largest studies of its kind analyzed 12,000 recipients of vaginal mesh and found that approximately 10 percent experienced mesh erosion within a year after surgery.

What is clear is that complaints are on the rise. From 2005 to 2007, the FDA took note of "over 1,000" reported instances of serious complications arising after the implantation of vaginal mesh. Attentions aroused, the agency began to keep a tighter watch - and their suspicions were apparently confirmed, with 2,874 reports of serious complications associated with transvaginal placement of surgical mesh filed between 2008 and 2010.

The nearly threefold increase in severe side effect reports prompted the FDA to reclassify vaginal mesh as a high-risk medical product in August of 2011. The high-risk classification does not mean health care providers need to stop using vaginal mesh completely. It does, however, serve as a warning to doctors and patient to be wary of vaginal mesh when there are other treatment alternatives available. For some women's groups, this is not enough; many are calling for a total recall of all vaginal mesh devices.

Purveyors of Surgical Mesh Strap on Armor as Legal Battle Intensifies

Unfortunately, the safety issues that seem to be endemic to vaginal mesh are not limited to the products produced by any single manufacturer or company. This complicates attempts to track the scope of the problem and notify patients who might be at risk; it also means lawsuits stemming from vaginal mesh devices are more of an intricate and interrelated web than a tidy, heterogeneous collection of individual cases.

Over 600 lawsuits against vaginal mesh manufacturers are currently pending. Johnson & Johnson, C.R. Bard, Boston Scientific and American Medical Systems are among the companies gearing up for litigation. No vaginal mesh cases have yet went to trial. However, a District Court judge overseeing the consolidation of vaginal mesh lawsuits filed in federal courts across the U.S. recently set a trial date of Feb. 3, 2013 for the first amalgamation of cases.

Compensation for Harm Caused By Vaginal Mesh

Even as more litigants flock to personal injury lawyers, the future remains uncertain. In order to collect damages at trial, victims must prove their claims, among them that vaginal mesh makers knew of the risks of their products but failed to disclose them and marketed defective items.

Any payment that ultimately materializes could be a boon to those affected by faulty vaginal mesh. One recent study found that among patients harmed by vaginal mesh, it took an average of two additional surgeries to fully remove the mesh and to repair any further damage. A payout could not only cover care costs of subsequent procedures linked to defective surgical mesh, but may also provide a premium for patients' pain and suffering, lost wages and any other incidental damages.

It is not always easy for women (or their doctors) to link a new gynecological issue with a past surgery, however, if you have had a vaginal mesh implant and are now experiencing pain or some other symptom, it could be that the two are related. Talking to your doctor is imperative to make sure you get the treatment that you need.

Speaking with an attorney is also advised. Your lawyer can talk with you about options available under the law. It's important to act quickly due to strict time limits for filing a lawsuit. An undue delay could jeopardize your right to monetary recovery.