FDA Releases Alert on Vaginal Mesh Complications

In October 2008, the FDA released a public health notification to alert women to the complications associated with the placement of surgical mesh systems used to treat stress urinary incontinence and pelvic organ prolapse. Over the course of three years, the FDA received more than 1,000 reports of vaginal mesh complications from nine separate manufacturers and warned that these vaginal sling problems may have serious consequences.

Over the course of three years, the FDA received more than 1,000 reports of vaginal mesh complications from nine separate manufacturers.

According to the FDA, the following were among the transvaginal mesh problems reported by women who underwent mesh surgery for pelvic organ prolapse or stress urinary incontinence:

• Mesh erosion
• Pain
• Urinary problems
• Mesh infection
• Recurrence of prolapse or incontinence

The FDA also received reports of pelvic mesh complications involving bladder, bowel and blood vessel perforation during insertion. In some cases, mesh erosion and vaginal scarring caused pain (including painful sex) and discomfort, leading to a subsequent decrease in the patient’s quality of life. Despite the number of vaginal mesh problems reported, and the complications associated with these side effects, the FDA has still not issued a vaginal mesh recall for the majority of these systems.

Although a wide-spread surgical mesh recall has not been issued, women who have experienced vaginal mesh complications may still be able to participate in a vaginal mesh lawsuit against the manufacturer. A vaginal mesh lawsuit would allow women who are experiencing vaginal sling complications the opportunity to seek compensation for medical bills, pain and suffering and other damages resulting from their mesh surgery complications. If you are experiencing mesh side effects, such as mesh erosion, following stress urinary incontinence or pelvic organ prolapse surgery, it’s important to seek legal assistance quickly.