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Watch live television, particularly late at night, and you’re bound to have seen advertisements for class-action lawsuits involving transvaginal mesh. These products are used in certain types of situations and have cause problems ranging from pelvic pain to organ perforation. In the wake of these lawsuits and numerous complaints, the FDA is taking action.
Earlier this year, the FDA declared transvaginal mesh to be among the riskiest of medical devices. While not issuing a recall, the agency announced that there would be more stringent regulations regarding the use of these devices.
FDA spokeswoman Deborah Kotz made a statement. “While the FDA acknowledges these devices do pose significant risks, these risks must be weighed against their potential benefits. For this reason the FDA does not believe that banning surgical mesh for vaginal POP repair is warranted at this time.”
The new regulations require the five manufacturers producing the devices to address concerns, including the severe pelvic pain and organ perforation.
Transvaginal mesh is used to treat a condition called pelvic organ prolapse. This condition occurs when organs fall from their usual positions and press against the walls of the vagina.
Transvaginal mesh products are now regulated as a Class III, which are items that carry the highest risks. To put this into perspective, a manual toothbrush is a Class I device and a condom falls under Class II.
The tightening of regulations was first discussed in 2014 and these were finalized last month. Between January of 2011 and December of 2015, the FDA logged more than 20,000 reports regarding these mesh devices. Most of the reports described complaints linked to the devices.
The FDA will continue to monitor the devices and to check how women receiving the transvaginal mesh are faring years after surgery.
If you or someone you know has suffered pelvic pain or organ perforation as the result of a transvaginal mesh device, you may be entitled to compensation. Contact the law offices of John Foy & Associates today.
