Abstract
Reports of problems with transvaginally inserted meshes for the prevention of Pelvic Organ Prolapse go back a number of years. Based on assessment of adverse event reports submitted to the FDA, evaluation of the published literature, and the September 2011 Obstetrics-Gynecology Devices Panel meeting, the agency is considering the recommendation that urogynecologic surgical mesh used for transvaginal repair of pelvic organ prolapse (POP) be reclassified from Class II to Class III as well as engaging with manufacturers and healthcare providers to collect further clinical data.
Background
In a 2011 analysis of serious complications associated with the use of transvaginally placed surgical meshes for prevention of Pelvic Organ Prolapse, the FDA concluded that serious adverse events were not rare and furthermore that there is no evidence that the technique is any more effective than traditional non-mesh repair. At that time the agency stated that it would continue to evaluate the situation which seems now to have resulted in it considering reclassifying these devices and furthermore engaging medical professionals and manufacturers in a heightened degree of scrutiny including not least an increased requirement for postmarketing study.
One doesn’t need to spend long browsing the internet to realise that there’s an issue here. Commentators, journalists and of course lawyers have been all over the situation for a few years now and the problem isn’t going away, especially as the FDA is now raising the stakes. According to an article this Wednesday in the New York Times;
In 2008, the F.D.A. issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse, said Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices.
Dr. Maisel emphasized that Wednesday’s order did not cover all uses of surgical mesh to treat incontinence. He added that the safety of such devices when surgically implanted through the abdomen was “well established.”
Top producers of vaginal mesh include Boston Scientific, C. R. Bard, Ethicon and W. L. Gore & Associates and all are likely to be heavily involved with FDA on this matter over the weeks and months to come.
Assessment measures
The FDA continues to assess the safety and effectiveness of urogynecologic surgical mesh devices, through:
- Review and analysis of published literature, Medical Device Reports (adverse event reports) submitted to the agency, and post-approval study reports.
- Epidemiological research on safety and effectiveness of surgical mesh, as a part of our effort to better understand possible adverse events associated with surgical mesh for SUI and POP.
- Collaborations with professional societies and other stakeholders to fully understand the postmarket performance of urogynecologic surgical mesh devices, as well as the occurrence of and signs and symptoms associated with specific adverse events.
- Collecting and reviewing all available information about currently marketed urogynecologic surgical mesh devices.
- Mandating postmarket surveillance studies (“522 studies”) by manufacturers of urogynecologic surgical mesh devices. On January 03, 2012, the FDA issued:
- 88 postmarket study orders to 33 manufacturers of urogynecologic surgical mesh for POP; and
- 11 postmarket study orders to seven manufacturers of single-incision mini-slings for SUI.
The manufacturers will be required to submit study plans to the FDA that address specific safety and effectiveness concerns related to surgical mesh devices for POP and single-incision mini-sling devices for SUI. Data from the studies will enable the agency to better understand the safety and effectiveness profiles of these devices. For information on the status of the 522 Postmarket Surveillance Studies and the FDA’s authority to order 522 studies, visit the 522 website.
What about outside US?
There’s no doubt that regulatory bodies outside USA will be keeping a very close eye on the situation, but to date appear silent on the subject, hence our detailed coverage of FDA’s position.
Source: FDA, New York Times
published: January 5, 2012 in: Alerts/Adverse Events, Boston Scientific, Ethicon, General Surgery, Gynaecology/Obstetrics, News, Regulatory