Study: New material may offer alternative to polypropylene vaginal mesh

According to a study published in the Journal of Neurourology and Urodynamics, scientists have developed a biomaterial that could offer an alternative to polypropylene vaginal mesh, which is currently used to treat pelvic organ prolapse (POP) and stress urinary incontinence, but has been linked to complications for many women. The authors said the material may "avoid complications due to a better mechanical match with the native tissues," although they cautioned that it "needs to be further evaluated in suitable preclinical animal models."

Researcher Sheila MacNeil noted that "surgeons have been treating the problems of urinary stress incontinence and [POP] using the only synthetic material they had to hand - polypropylene." MacNeil added that "this whole area has suffered from a lack of research because the manufacturers denied there was a problem…and patients weren't listened to."

She remarked "we have focused our efforts on polyurethane, using the method of electrospinning to create a fine mesh, which we have fabricated in layers to mimic the structure of human tissue." According to the scientists, polyurethane is softer and more flexible than polypropylene, while the material's greater elasticity makes it better equipped to sustain the pelvic organs.

The scientists also introduced oestrogen into the polyurethane mesh in an effort to aid the healing process. The study showed that the addition of oestrogen stimulated cells to "produce new tissue and form new blood vessels – regenerating the tissue and ultimately speeding up the healing process," while not compromising the mesh's strength and elasticity, the researchers said. MacNeil suggested that the new material "does not provoke inflammation and retains its strength and elasticity. The addition of oestrogen is a major breakthrough as we have proved its beneficial effects in regenerating pelvic tissue."

A number of companies, such as Boston Scientific, Johnson & Johnson's Ethicon unit and C.R. Bard, are facing lawsuits in numerous countries, including the US, Europe and Australia, over transvaginal mesh products. Johnson & Johnson was sued by the US states of Washington and California in 2016 over claims that the company misrepresented the risks of vaginal mesh implants it sold to repair POP. In April last year, more than 800 women in the UK were preparing to sue the NHS and vaginal mesh implant manufacturers due to pain and injury related to the devices. Last July, a class action lawsuit involving more than 700 women in Australia was filed against Johnson & Johnson over complications allegedly caused by the company's vaginal mesh implants.

In the US, the FDA issued an order in 2016 to reclassify surgical mesh used in transvaginal repair of POP from class II devices to class III, while a second order required manufacturers to submit a premarket approval application to support the safety and effectiveness of those devices. Meanwhile, Australia's Therapeutic Goods Administration said last November it would remove from the Australian Register of Therapeutic Goods transvaginal mesh products whose sole use is the treatment of POP via transvaginal implantation. The following month, New Zealand's health ministry announced that it was taking steps to remove from supply and limit the use of certain surgical mesh products for the repair of POP and stress urinary incontinence.  Later that month, the UK National Institute for Health and Care Excellence issued updated guidance recommending against transvaginal mesh repair as a treatment for anterior or posterior vaginal wall prolapse, citing safety concerns and insufficient data of long-term benefit. 

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