'A Criminally Negligent Medical Device Regulatory System': UK Mesh News Provokes Outrage
The EU medtech regulatory system is coming under fire again in the UK, being blamed for the vaginal surgical mesh scandal as action is taken to limit procedures. But this is a global problem.
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Surgical mesh products whose sole use is the treatment of pelvic organ prolapse via transvaginal implantation will no longer be supplied in New Zealand, Medsafe says.
The US agency has agreed with an earlier assessment by an advisory panel last year to up-classify surgical mesh instrumentation by issuing a Jan. 6 final order to move the instrumentation – used for women undergoing pelvic organ prolapse or female stress incontinence procedures – from class I to class II.
Existing manufacturers of transvaginal surgical mesh for pelvic organ prolapse procedures, including Boston Scientific Corp., ACell Inc., Coloplast AS, and American Medical Systems Holdings Inc., will have to file for PMAs in 30 months to keep their mesh products on the markets, says FDA in a Jan. 4 final order.