Surgical Mesh Complications
United States health officials with the Food and Drug Administration (FDA) are sending a clear warning to physicians and the general public: pelvic mesh complications and surgical mesh products used to treat pelvic organ prolapse (POP), stress urinary incontinence (SUI) and other women’s health conditions are causing serious complications for women – a lot more than previously estimated – and are exposing women to potentially dangerous, life-threatening risks that include everything from bleeding to death. As a result many vicitims are turning to a Surgical mesh attorney and vaginal mesh law suit.
Surgical mesh is a metallic or polymeric screen that is surgically implanted to reinforce and support soft tissue or bone that have weakened. The FDA announced that surgical mesh implants, when used to support reproductive organs, put women at significantly greater risk of transvaginal mesh complications than women who have traditional procedures with stitches. Surgical procedures using mesh can create more problems than benefits for women, the FDA warns.
For this reason, the FDA is advising patients and physicians to consider other options, citing an avalanche of reports of complications that include:
- Urinary difficulties
- Recurrence of prolapse and/or incontinence
- Bowel and bladder blood vessel perforation during insertion
- Dyspareunia (pain during intercourse) due to vaginal scarring
At the same time, the FDA is warning physicians to inform patients considering mesh placement of the serious potential for the vaginal mesh complications listed above and also to obtain specialized training for procedures that involve placement of surgical mesh. FDA officials are advising healthcare professionals to “be vigilant for potential adverse events from the mesh, especially erosion and infection” and to “inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.”
More than half a million women suffer from undergo surgery every year for POP and USI. In 2010, approximately 75,000 had POP surgery with mesh inserted through the vagina and more than 200,000 women had the procedure for USI. A less common version of the procedure, where surgeons insert the mesh through the abdomen, is known to have fewer complications, according to the FDA.
After reviewing literature and complaints during the past 15 years, the FDA has acknowledged its mistake in issuing a public notice that called mesh problems “rare.” In the October 20, 2008, FDA Public Health Notification, more than 1,000 adverse events associated with surgical mesh devices used to repair POP and SUI for the previous 3-year period (2005 – 2007). Following this, from January 1, 2008, through December 31, 2010, the FDA received 2,874 additional reports of these complications, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs. “Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse event reports remains high,” the FDA announced this year.
Today, the FDA estimates the problems most commonly arise in 10 percent of women within a year of surgery, and these patients often undergo multiple surgeries to remove the mesh. The most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. Reports also include recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.
The FDA announced that its literature review reveals that:
- Mesh used in transvaginal POP repair presents risks that do not exist in the traditional surgery.
- Mesh placed abdominally for POP repair seems to result in fewer complications than when it is inserted transvaginally.
- No evidence exists that transvaginal repair with mesh to support the top of the vagina (apical repair) or the back vaginal wall (posterior repair) provides any additional benefits when compared with the traditional surgery that does not involve mesh.
- Mesh erosion through the vagina is the most common complication from transvaginal POP surgeries using mesh. This can require multiple surgeries to fix and can debilitate women. Sometimes, even multiple surgeries will not fix the problem.
- Mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that is reported to involve vaginal shortening, vaginal tightening and vaginal pain.
The consequences of mesh erosion and mesh contraction include severe pelvic pain, painful sexual intercourse and an inability to engage in sexual intercourse. Furthermore, men may feel irritation and pain to the penis during intercourse when the mesh is exposed in mesh erosion.
Numerous women have filed lawsuits against medical devices manufacturer and marketer C.R. Bard, which introduced its Avaulta Anterior and Posterior BioSynthetic Support System in 2007. The suits allege CR Bard negligently designed the surgical mesh and failed to warn patients that serious complications and physical pain can result. Problems with vaginal mesh have been associated with products made by several other manufacturers, including:
- American Medical Systems (AMS)
- Boston Scientific
- Johnson & Johnson
Considering the high number of women undergoing these procedures and reporting complications, the FDA’s Dr. Maisel recommends that patients and their physicians first consider traditional prolapse surgery, which involves repositioning and tightening the pelvic floor with stitches. Although the procedure has a 20-45% failure rate, it is generally considered the safest alternative available today.