Tuesday, January 17, 2012

Transvaginal Mesh: A Brief History of the Problematic Implant

While the past three years have brought an influx of complications and problems related to the transvaginal mesh implant, the device has actually been in use for over half a century. Surgical mesh made of metallic or polymer screens was developed for use in abdominal hernia surgeries in the 1950’s, however gynecologists soon saw the advantages of using the mesh in the surgical repair of stress urinary incontinence and pelvic organ prolapse. These problems are relatively common among women who have had children, undergone a hysterectomy or are post-menopausal. During such events, the muscles and ligaments which surround the pelvic organs can weaken, allowing those organs to slip out of their natural place, or prolapse.

FDA Approves Surgical Mesh for Abdominal Surgeries

Surgical mesh was originally approved for abdominal applications; since pelvic organ prolapse surgeries were performed abdominally in the 70’s, the mesh appeared to be a good solution for POP surgeries as well. Prior to the development of mesh, hernia repair was performed using suture techniques which garnered recurrence rates from 24-54%. Once the mesh began to be widely used to repair hernias, the recurrence rates dropped to 10-20%, however placement and fixation of the mesh was crucial for a positive outcome. In the late 1980’s surgeons began positioning the mesh with an overlap of 5 cm in all directions around the hernia defect, and the recurrence rates dropped as low as 3.5%.

Transvaginal Use of Mesh

Following several decades of success in using the mesh implants, the 1990’s brought such great advances in surgical techniques as well as in the mesh technology itself that gynecologists began using the mesh in both SUI and POP transvaginal surgical procedures. At this time there was still no “official” surgical mesh product available for these procedures, therefore the surgeons simply cut the mesh themselves whenever they used the abdominal mesh in vaginal applications. Manufacturers of the mesh saw an opportunity, and began producing kits which included both the mesh as well as tools which supported the surgical delivery and insertion.

FDA Approval for Transvaginal Use

Actual FDA approval of the mesh for transvaginal surgeries did not take place until a mesh developed by Boston Scientific was approved in 1996 for use in stress urinary incontinence surgeries. Unfortunately, the year following that approval saw problems with this particular mesh product with over 120 patients reporting serious side effects. Even though Boston Scientific’s ProteGen was voluntarily pulled from the market in 1999, the manner in which FDA approval was granted allowed subsequent products to be approved using the ProteGen as a predicate device. Even though surgeons had been using mesh in pelvic organ prolapse surgeries for many years, it was finally granted FDA approval for this particular application in 2002.

Unexpected Problems Arise

Although for the most part the mesh products worked well in the areas of the abdomen which were limited in flex, the pelvis has a much different physiology. Pelvic regions such as the vagina tend to be highly flexible and much more delicate than the abdomen, and the stiff, inelastic mesh did not work as well with the fragile tissues. In many cases the mesh would shrink and become rigid, pulling at the delicate surrounding areas and even eroding through the tissue walls.

Today’s Mesh Implant Devices

There are four types of surgical mesh on the market today, the most common of which is made of a non-absorbable polyester or polypropylene mesh and used in most female urology surgeries. Other types include an absorbable, synthetic mesh, a mesh made of animal tissues and a mesh which is a combination of the other types. As many as half a million women each year undergo POP or SUI surgeries each year; in 2010 some 75,000 had POP surgery using the mesh in a transvaginal application while more than 200,000 had the procedure for stress urinary incontinence. There is a less common version of these procedures in which the surgeon implants the mesh through the abdomen and is believed by the FDA to produce fewer complications.

2008 Public Health Notification

The FDA issued a public health notice in October of 2008 in which they acknowledged a mistake in issuing a prior notice which called mesh problems “rare.” In the 2008 notification, more than a thousand adverse events were definitively associated with surgical mesh implants used in POP and SUI surgeries for the period from 2005-2007. From January, 2008 through December, 2010, the FDA received nearly three thousand more reports of complications from the mesh. Even when taking into consideration the fact that it is fairly common for adverse event reporting to increase following an FDA safety notification, the numbers were felt to be unduly high.

Mesh Use Today

Today many problems such as recurrent prolapse, mesh erosion, pain, infection, bleeding, urinary problems and pain during sexual intercourse are being reported. The FDA believes that such problems commonly occur within a year of the original surgery, and patients who experience complications may be subjected to multiple surgeries in order to successfully remove the mesh implant. After careful consideration the FDA advisory committee has suggested that the current transvaginal mesh products will remain on the market however more stringent warnings for use will be issued. Future products of this type will be forced to undergo stricter testing in order to be granted FDA approval.

Author: Sullo & Sullo Attorneys

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