January 3, 2011 - According to the results of a recent marketing study conducted by the Millennium Research Group (MRG), transvaginal mesh manufacturers saw sales fall flat in 2011 amidst controversy surrounding the alleged side effects of the devices.
The MRG study found that doctors’ confidence in vaginal mesh slings for the repair of pelvic organ prolapse (POP) has been shaken by thousands of consumer complaints, legal claims, and tightened federal restrictions over the past year.
The research included a survey of 181 healthcare professionals, 130 of whom currently use transvaginal mesh products to treat POP and stress urinary incontinence (SUI). The study participants reported overwhelmingly that they have less confidence in vaginal mesh devices now than they did a year ago.
Last summer, the U.S. Food & Drug Administration (FDA) issued a press release warning the public about the adverse health risks associated with vaginal mesh, indicating that it could find no benefit in using the devices when compared to older, more conventional alternatives.
Between 2008 and 2010, the administration received more than 1,500 injury reports associated with vaginal mesh, including:
- erosion of the mesh into the vagina
- contraction or shrinkage of the mesh
- pelvic pain
- urinary problems
- vaginal scarring
- miscellaneous complications
Around the country, a growing number of lawsuits have been filed on behalf of women alleging that transvaginal mesh manufacturers created defective products and failed to adequately warn both doctors and patients about the risk of potential side effects.
Manufacturers currently named in vaginal mesh lawsuits include Johnson & Johnson’s Ethicon unit, C.R. Bard, Boston Scientific, and American Medical Systems (AMS).