Transvaginal Mesh

Dangerous Drugs & Devices

What Is Transvaginal Mesh?

Surgical mesh is a net-like medical device that provides support to weakened or damaged tissue. For decades, surgical mesh has been used successfully to treat hernias; in the late 1990s it was introduced as a solution for female stress urinary incontinence (SUI) and pelvic organ prolapse (POP). These conditions, caused by weak pelvic muscles, can occur after a hysterectomy, menopause or childbirth. The mesh is designed to support the problematic organs.

Transvaginal mesh surgery, where the mesh is inserted vaginally, was believed to be a safer and less-invasive procedure than placing the mesh through the abdomen.

Unfortunately, transvaginal mesh has caused serious and debilitating complications for thousands of women. Should the manufacturers have known? We think so. Simply put, there is a huge difference between putting mesh into an abdominal muscle to solve a hernia and putting it in the female reproductive areas. The amount of nerve endings, close proximity of other organs, and other issues make it an obviously poor decision.

What Are The Potential Injuries?

Complications are frequent when the mesh is inserted vaginally. The mesh can cut through the vaginal wall into surrounding organs, which causes chronic pelvic pain and vaginal scarring. Other problems include:

  • Mesh eroding into the vaginal tissue
  • Recurrence of the original medical issue
  • Infection
  • Bleeding
  • Pain during intercourse
  • Incontinence

Surgery to repair the damage is often required in cases involving pelvic organ prolapse. Since the mesh is designed as a permanent medical device, removing it can be a difficult. If the mesh has grown into the body, multiple surgeries may be required to remove the device piece by piece. A second surgery is less likely to be needed when the mesh was used to repair stress urinary incontinence, but is still necessary in some cases.

What Are The Potential Injuries?

Tens of thousands of women have been injured by transvaginal mesh. The companies being sued for their injuries include C.R. Bard, American Medical Systems, Boston Scientific Group, Cook Medical Inc., Coloplast Corp., Neomedic and Ethicon Inc. More than 50,000 claims have already been filed and up to 100,000 are expected.

Many manufacturers have stopped producing and selling the types of mesh most likely to cause injury. Surprisingly, the Food and Drug Administration (FDA) has not issued a formal product recall. The FDA did not require testing on humans before allowing the products to be implanted in women; so far it has only issued warnings and required post-market studies.

Since lawsuits are being filed against multiple companies and in many different jurisdictions, these cases have been grouped together into a federal multi-district litigation (MDL). One federal judge is in charge of the litigation so that the legal and factual questions the cases have in common can be decided more easily and consistently. For instance, if the judge rules that a certain side effect was caused by the mesh, his decision will apply to all the lawsuits.

Because each woman suffered one or more of a set of injuries—rather than each woman having the same injury—each case has been filed individually and grouped together as a mass tort lawsuit rather than a class action.

What Is The Legal Outlook?

Individual cases are still being filed, and, while some companies are settling, litigation is likely to continue for quite some time. One company has already set aside $1.3 billion to settle cases, and four other companies are expected to follow shortly. In the face of overwhelming evidence, we believe all of the manufacturers are going to settle these cases in the near future.

If you have experienced negative side effects after undergoing transvaginal mesh surgery, contact Oxner + Permar for a free consultation.