Transvaginal Mesh: Regulators Urged To Act More Decisively

In short

US consumer protection website drugwatch.com is pointing the finger at regulators in US and UK over vaginally inserted mesh, another medical device issue that isn’t going away. In an article on its pages, it claims that “as more women who have been victim to faulty transvaginal mesh devices across the United States come forward, medical device regulators here and in the United Kingdom continue their sluggish investigations into devices that have caused severe injuries and death”.

Background

In the post, which appears on drugwatch.com here, the author accuses the FDA of having been rather too silent on the subject of what it calls “faulty” transvaginal mesh products that are used to treat pelvic organ prolapse (POP) and urinary incontinence.

She might have a point, because we’ve been covering the story and a quick look back shows our most recent item to have been posted in early January here, rather a long time ago if you’re a victim.

The drugwatch feature states that “despite findings that the plastic mesh used to hold up fallen organs typically cuts into the vaginal walls, perforates tissues and organs and causes infections, the FDA has not made any moves toward banning the mesh.”

Our own coverage detailed mainly FDA’s heightened degree of scrutiny and deliberations about reclassifying meshes as Class III, thereby taking them out of the 510(k) approval route. But that’s about it, and UK’s competent authority, the MHRA doesn’t emerge much better, seemingly still in deliberations about what to do.

We say

Adopting our usual position of balance and two sides to every story, we don’t believe knee jerk reactions play well in medical device regulations, but equally in this case we’re wondering why there seems to be an acceptance of the status quo and a lack of obvious urgency among regulators both sides of the pond. While it’s always possible to find victims of pretty much any surgical procedure, and easy to use them as examples, in this case there appears to be a significant and growing caseload and a lot of unanswered questions.

Source: drugwatch.com