The Dangers of Defective Medical Devices

Hurt In Mississauga is no longer accepting transvaginal mesh cases.

Transvaginal Mesh Attorneys

What Is Transvaginal Mesh?

Transvaginal mesh is a medical device that was implanted in thousands of women across the United States to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

POP is a condition in which pelvic organs (such as the uterus) fall out of place and fall through the vagina or press against the vaginal wall. This condition can be painful, and it often requires corrective surgery, although some mild cases only require prolonged rest. SUI is similar in that the sphincter and other muscles have become too weak to control the flow of urine. Vaginal mesh has also been used to treat this condition. Women were promised that this mesh would treat their prolapse and incontinence, but many women experienced early failure of this medical device that caused extreme pain, and in some cases, necessitated additional corrective surgeries.

Synthetic mesh is not a new medical device, but one that was previously on the market to treat hernias. Per the FDA’s 501(k) fast track approval process, this synthetic mesh was also approved with limited testing for the treatment of vaginal complications. Although the synthetic mesh is typically successful in hernia corrective surgeries, this was not so in the case of vaginal placement. The mesh is made of polyester or polypropylene and is typically inserted through a small incision in the vagina and surrounding tissue. The mesh is designed to work with the body’s own tissue, but many women’s bodies actually rejected the mesh, causing the severe side effects.

Vaginal Mesh Side Effects

One of the major side effects of transvaginal mesh is erosion. Erosion of the mesh means the mesh has become hardened and can break off or cause other pelvic organ damage. Mesh has been known to become sharp and puncture internal organs or fall out of place. In either situation, eroded mesh can cause excruciating pain that requires corrective surgery to treat. In other scenarios, mesh can cause serious infection of the surrounding tissue. Another side effect of transvaginal mesh failure is painful or impossible sexual intercourse. It can also make urination painful.

From January 1, 2008 to December 31, 2010, the FDA received nearly 2,900 reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse and stress urinary incontinence. 1,371 were associated with SUI repairs and 1,503 were associated with POP repairs.

The most common complaints in these reports were the following:

  • Pain
  • Infection
  • Bleeding
  • Erosion through the vagina
  • Pain during intercourse
  • Organ perforation
  • Urinary problems
  • Recurrent prolapse
  • Vaginal scarring/shrinkage

Transvaginal mesh side effects are not only painful but are serious and will require medical treatment. Surgery and hospitalization are likely.

FDA Warning for Transvaginal Mesh

The FDA released an update regarding complications associated with transvaginal placement of surgical mesh for POP. The update stated, “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”

It went on to provide helpful information about POP and SUI and how, from January 2008 through December 2010, the FDA had received nearly 2,900 reports of complications associated with transvaginal mesh to treat these conditions. This has therefore been identified as an area of continuing concern, and healthcare providers and patients alike should be informed of the potential dangers associated with transvaginal mesh.

Alternatives to Transvaginal Mesh

Prior to the use of transvaginal mesh in the early 1990s, POP and SUI was treated with either non-surgical options or the body’s own tissue. One popular non-surgical treatment is a vaginal pessary. This is a device used to support the vagina that can be inserted by your doctor without anesthetic or incisions. This device must be changed out every three to six months. Due to discomfort, many women opted for mesh surgery instead. Surgical procedures have often involved using a woman’s own tissue to re-secure pelvic organs into place.

Manufacturers of Transvaginal Mesh Products

There are many manufacturers of transvaginal mesh products, but the main companies are:

  • Boston Scientific
  • American Medical Systems
  • Ethicon/Gynecare

Currently, there is ongoing litigation over mesh implants, although the FDA has not issued a total recall of this type of product. The FDA has changed their warnings about the product though. In 2008, the FDA claimed that severe side effects associated with the mesh were “rare,” but it now states that product failure and injury are more frequent than this. Many women do not know of their right to legal action in conjunction with transvaginal mesh. Those who experienced complications or had to endure corrective surgery should talk to their doctor.

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