According to a report issued today, November 7, by Millennium Research Group (MRG), the market for pelvic floor reconstruction vaginal slings is predicted to decline significantly. See the report here, and the Press Release here:
The industry has experienced steady growth for the past several years due to aggressive marketing to the Baby Boomer generation, the target audience for pelvic organ prolapse and urinary incontinence vaginal slings. MRG does market research and provides strategic information to the healthcare industry.
According to MRG several factors are softening sales by more than 15% in 2011 to under $115 million:
- Poor Clinical Outcomes
- FDA Public Health Notice (actually one in 2008 another in July 13, 2011)
- Lawsuits (hundreds at the least, possibly running into the thousands and not just in the U.S. but in Canada and the UK)) will make surgeons less likely to use the devices and patients less likely to request them.
The synthetic market is more affected than biologic mesh made from animal skin primarily because the FDA’s warning mentioned only the nonabsorbable synthetic mesh which is synthetic.
Boston Scientific, Ethicon and American Medical Systems should expect significant losses.
The research group predicts a 7% slip in sales for vaginal slings in 2011. Interestingly, MRG predicts negative publicity will fade by the year 2014 and the vaginal sling market will recover.
All of this is good news for Cook Medical which makes a biologic mesh without prolene, and is differentiating itself from synthetic vaginal prolapse mesh.