By Independent Staff Writer
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.
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.
