Although the FDA has received over 2,000 verifiable reports of complications resulting from vaginal mesh surgery, the procedure is still being performed on hundreds of thousands of women. Most vaginal mesh surgery is used to treat one of two conditions: stress urinary incontinence (SUI) or pelvic organ prolapse (POP). Because the procedure was approved in 1996 and the first FDA warning was not issued until 2008, several lawsuits concerning vaginal mesh complications have been filed in nearly every state.
Vaginal Mesh Surgery
Vaginal mesh surgery sprang from the use of surgical mesh for the treatment of abdominal hernias. Surgical mesh is a flexible, perforated material that is surgically attached to tissue to hold organs or other tissue in place. After more than 40 years of being used for hernias, doctors began experiment with surgical mesh in transvaginal surgery to treat POP and SUI. Vaginal mesh surgery was approved to treat SUI in 1996 and POP in 2002.
Vaginal Mesh Complications Reported to FDA
Around 2005, nine years after vaginal mesh surgery was first approved, the FDA began receiving reports of complications resulting from the procedure. Some complications were merely the recurrence of the initial medical condition, but other, more severe complications also began to be reported.
As a result of several hundred reports of complications issued to the FDA from 2005 to 2008, an official safety notice was issued stating that in rare circumstances, complications may arise. No further recommendations were given, and the procedure continued to be used.
From 2008 to 2010, nearly 1,500 new reports of vaginal mesh complications were directed to the FDA. This prompted an update to the safety notice in 2011. The update retracted the earlier statement that complications were rare. It also noted that the procedure was no more effective than traditional procedures that do not use vaginal mesh.
Specific Vaginal Mesh Complications
Several side effects were included in the reports received by the FDA. Among the most common were pain, infection, urinary incontinence and difficulty urinating. However, several more serious complications were also noted, such as internal or vaginal bleeding, vaginal scarring and an inability to engage in sexual intercourse.
Many of the complications arising from vaginal mesh implants occurred due to vaginal wall erosion. When the surgery was first approved, it was stated that vaginal mesh could be absorbable by the body or unabsorbable. Absorbable mesh was supposed to dissolve before complications could arise, and permanent mesh was not supposed to cause complications at all.
However, what was reported was that the mesh was irritating vaginal tissue where it was attached. In some cases, the irritation could be so severe that it caused the wall of the vagina to erode and develop perforations. This tissue damage can lead to pain and requires surgery to correct.
A transvaginal mesh patch is implanted as a treatment for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). It is an alternative to a traditional method of stitching called colporrhaphy. Unfortunately, not only have dangerous complications arisen with the patches, but they are also not proven to be any more effective than colporrhaphy, according to the FDA’s most recent safety alert.
Serious Side Effects
The FDA issued a safety announcement in July 2011 concerning transvaginal mesh implants. According to the agency, serious complications associated with using transvaginal patch to repair POP include:
- Mesh erosion of the implant through the vagina (also referred to as exposure, extrusion or protrusion)
- Bladder perforation
- Pain during sexual intercourse (dyspareunia)
- Organ perforation (puncturing)
- Urinary issues
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring or shrinkage
- Associated emotional problems
Study: Bladder Perforation 7 Times More Likely With a Transvaginal Mesh Implant
Pelvic organ prolapse (POP) is a condition that can be corrected with a surgical procedure known as anterior colporrhaphy, in which the weakened area of connective tissue is stitched back together. A newer treatment involves putting a piece of synthetic mesh, called a transvaginal mesh patch or implant, in place to anchor the organs. These patches have been found to carry dangerous risks, despite not being proven to be any more effective than colporraphy.
A study conducted in Europe compared the two methods and found that bladder perforation or puncture was 7 times more likely for women who received the mesh patch compared to those who underwent the colporrhaphy procedure.
FDA Warns of Organ Damage
A July 2011 Safety Alert by the Food and Drug Administration (FDA) stated that complications with transvaginal mesh could include perforation of the bowel, bladder or blood vessels from tools used during placement of the implant.
Contact our law firm using the form on this page to speak with an attorney who will explain your legal rights. Our knowledgeable attorneys will listen to your story and help you determine the best course for your case. Compensation may be available from the manufacturer of this dangerous product to recover your medical expenses and compensate you for your hardship.
Contact our Patient and Family Advocates if you or a loved one is suffering complications from the use of vaginal mesh. They will be happy to assist you with both your medical questions, where appropriate, will help you make contact with attorneys that are experts in dealing with claims involving vaginal mesh.