The U.S. Food and Drug Administration (FDA) first became concerned about vaginal mesh in October 2008. The agency issued a “Public Health Notification” informing the public that in the three-year period between 2005 and 2007, it had received 1,000 adverse event reports related to vaginal mesh. At the time the FDA believed that mesh-related complications were rare, but in the subsequent three years, 2008 through 2010, the agency received an additional 2,874 adverse event reports. 1,503 reports were for pelvic organ prolapse (POP) repairs and the remaining 1,371 were from patients with stress urinary incontinence (SUI). Due to the increase in reports and the results of systematic review of the academic literature published since 1996, on July 13, 2011, the FDA issued an “Update on Serious Complications Associated With Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse” that warned the public that mesh complications were not rare at all.
FDA Vaginal Mesh Warning Focuses on POP Complications
Although the FDA is still evaluating the literature on SUI, in the 2011 warning it concluded its research for POP, and its findings were not pleasant. The agency found that women who received mesh reported the following symptoms:
- Vaginal bleeding or discharge
- Pelvic or groin pain
- Dyspareunia (pain during sex)
- Urinary problems
- Organ perforation
- Recurrent prolapse
- Neuro-muscular problems
- Vaginal scarring and shrinkage
- Emotional problems
- Mesh “erosion” (really “exposure” or “protrusion”) through the vaginal wall
The FDA determined that the final symptom, mesh erosion, was the most common problem associated with mesh used to treat POP. The FDA warning stated, “Mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not solve the complication.” The agency added that in some cases it could not determine if vaginal mesh resulted in better outcomes for treating POP than traditional methods.
No Single Mesh Brand Responsible
Because vaginal mesh is a generic medical device, more than one company manufactures it. The biggest names in the field are C.R. Bard, American Medical Systems, Boston Scientific, Ethicon (a Johnson & Johnson subsidiary), and Coloplast. Unfortunately, the FDA found no relationship between adverse mesh outcomes and any one company. Instead, all types of mesh were equally likely to cause complications in women.
Subsequent FDA Activities
After the July 2011 warning, the FDA convened the Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee on September 8-9, 2011, and the FDA has begun assessing whether vaginal mesh should be reclassified as a Class III medical device rather than a Class II medical device. In January 2012, it used its regulatory authority to mandate vaginal mesh manufacturers conduct postmarket surveillance studies on their products, totaling 88 products to treat POP made by 33 companies, and 11 products for treating SUI made by seven manufacturers.
Call RLG If You Have Been Injured by Mesh
If you underwent a mesh placement surgery and have suffered any of the complications listed above, you might be eligible for compensation from the manufacturer by filing a vaginal mesh lawsuit. The lawyers at the Rottenstein Law Group are committed to helping people like you, and for a free, confidential consultation, click on this link or call 1-888-519-7362 as soon as possible.