Pelvic floor recon market to shrink by over 15% on safety concerns
By Madeleine Armstrong

The pelvic floor reconstruction market, comprising devices such as the transvaginal meshes which were at the centre of a safety storm this year, will see sales decrease by over 15% this year, according to the Millennium Research Group (MRG). The organisation valued the market at around $115m in 2011.

MRG analyst Sohaib Perwaiz noted that the sales declines are particularly striking given the increasing prevalence of indications such as pelvic organ prolapse and urinary incontinence, which the devices are used to treat. The ageing population and the growing prevalence of obesity have both led to the rising incidence of prolapse.

MRG says that surgeons are becoming increasingly hesitant to use pelvic floor repair devices in an effort to avoid lawsuits. Safety concerns with transvaginal meshes came to light in September when a US FDA panel met to discuss their reclassification to “high-risk” devices requiring premarket approval (www.clinica.co.uk, 9 September 2011). The meshes, made by the likes of Johnson & Johnson and CR Bard, were previously regulated under the less-stringent 510(k) procedures.

The meshes reinforce vaginal tissue and are intended to treat pelvic organ prolapse, when the pelvic floor muscles weaken and organs such as the bladder and uterus bulge into the vagina. However, they have been linked with complications including erosion through the vagina (the most frequent side-effect), pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. The problems have not been linked with a single brand of mesh.

J&J and Bard are facing around 500 lawsuits from women suffering side-effects after being implanted with the devices. One of the lawyers bringing claims against J&J, Adam Slater of New Jersey law firm Mazie Slater Katz & Freeman, had toldClinica that injured women could each be in line for millions of dollars in compensation ( www.clinica.co.uk, 12 September 2011).

The lawsuits involve the Gynecare Prolift pelvic floor repair system, manufactured by J&J’s Ethicon subsidiary, and Bard’s Avaulta system. Other companies selling transvaginal meshes include Boston Scientific and American Medical Systems.

As well as potential damages, the manufacturers are now looking at “significant sales losses”, according to Millennium. It notes that the synthetic mesh market will decrease more significantly than the biologic mesh market until 2016 because the FDA’s advisory committee specifically highlighted complications associated with nonabsorbable synthetic meshes.

One positive is that the current concerns could help pave the way for new entrants with safer alternatives, particularly in the biologic segment. This includes Cook Medical, which has made significant efforts to differentiate its biologic products from the types of devices highlighted by the FDA advisory committee, Millennium said. For example, it has developed the Biodesign biologic graft which can be used in pelvic floor repair.

Knock-On Effect

Vaginal slings, which are used to treat stress urinary incontinence, will also suffer from the negative publicity, although the FDA panel concluded that these devices are safe and do not require reclassification. Nonetheless, Millennium reports that the overall vaginal sling market will shrink by over 7% in 2011, but is expected to resume growth by 2014 as the effects of the negative publicity fade.

The figures are included in MRG’s report US Markets for Soft Tissue Repair Devices 2012.

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