Surgery to Repair Pelvic Organ Prolapse
An article in a 1999 issue of the American Journal of Obstetrics and Gynecology concluded that a woman's risk of having pelvic organ prolapse (POP) during her life were between 30 and 50 percent. Of these, 2 percent of women become symptomatic.
When less invasive treatments don't successfully help relieve the discomfort and displacement of prolapsed organs, surgery is an option many women and their doctors choose. The reason for the surgery is to support the organs that have fallen out of place and to relieve a woman's discomfort.
Surgical Mesh to Repair Pelvic Organ Prolapse
One approach is to use surgical mesh, a type of screen composed of metal or polymer, to reinforce soft tissue where there is weakness. The first use of surgical mesh was in the 1950s for mending hernias. Then, in the 1970s, gynecologists started using surgical mesh for an abdominal surgical approach to repair pelvic organ prolapse.
Surgeons in the 1990s began to use surgical mesh to repair stress urinary incontinence (SUV—urination due to some stress on the bladder such as sneezing) and repair pelvic organ prolapse by operating through the vagina or transvaginally. In 2002, the U.S. Food and Drug Administration (FDA) approved the first surgical mesh product to be used specifically in the repair of pelvic organ prolapse.
Surgical mesh is meant to make POP repairs more durable. Generally, the mesh is cut to match the anatomical defect it is repairing.
Surgical mesh materials come in four basic categories:
- Non-absorbable synthetic
- Absorbable synthetic
- Biologic (collagen taken from cow or pig sources)
- Composite (a combination of any of the above three types)
Surgical mesh was used to repair stress urinary incontinence before being used to treat pelvic organ prolapse. Because stress urinary incontinence mesh surgeries were proving to be successful, surgeons began to use surgical mesh in transvaginal procedures to repair POP.
Traditional Non-Mesh Surgery to Repair Pelvic Organ Prolapse
Before the introduction of surgical mesh products to repair pelvic organ prolapse, the traditional approach was to stitch the organs in place and use stitches to reinforce weak tissues. Then, a transabdominal (operating through the abdomen) approach to repairing pelvic organ prolapse with mesh was used with great success in the 1980s and was accepted by gynecologists as an effective way to treat POP.
Risks Involved with Transvaginal Placement of Surgical Mesh
According to the FDA, which reviewed market data from manufacturers, in 2010 about 300,000 women had surgery to repair pelvic organ prolapse and about one out of three of these surgeries used surgical mesh. Three-quarters of the POP surgeries using mesh were done transvaginally.
The FDA searched a database containing adverse event reports made between Jan. 1, 2005, and Dec. 31, 2010, regarding all urogynecologic (for urinary as well as gynecologic reasons) surgical mesh products.
The data search showed that there were 3,979 reports of injury, death and malfunction. In the last two years, 1,503 of these reports had to do with pelvic organ prolapse repairs. The number of adverse events associated with pelvic organ prolapse reported during the last two years had increased five-fold compared to the number of reports in the previous three years.
Complications from using surgical mesh to repair pelvic organ prolapse that were reported most often to the FDA between 2008 and 2010 include:
- Vaginal mesh erosion (this also was labeled exposure, extrusion or protrusion)
- Pain (this included painful intercourse)
- Urinary problems
- Organ perforation
Other recurrent problems that were reported were:
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring or shrinkage
- Emotional problems
Many of the reports of adverse effects also reported a need for further treatment, including medical and surgical treatment and hospitalization.
Among its summary of key findings in the July 2011 report, the FDA said, "The FDA has NOT seen conclusive evidence that using transvaginally placed mesh in POP repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk."
Seek Financial Compensation
If you've undergone surgery to treat pelvic organ prolapse and have suffered complications, our transvaginal mesh attorneys may be able to help you seek compensation for your injury and suffering. To learn more, please contact us today.