By Jim Dickinson
Several advocacy groups are voicing strong support for a proposed FDA order to reclassify surgical mesh used to repair transvaginal pelvic organ prolapse (POP) from Class II to Class III.
Consumers Union, the policy and action arm of Consumer Reports, and its related patient safety network advocates say in a recently posted comment that they also support reclassification of surgical instruments used for mesh insertion from Class I to Class II and a requirement that makers of current mesh products submit a PMA.
The groups fault FDA for delays in proposing the orders and express concern that the proposal does not include mesh used to treat stress urinary incontinence (SUI).
“Since the use of surgical mesh for this purpose is also marketed after completing only a 510(k) review,” the letter says, “there will continue to be no clinical evidence as to the safety and effectiveness of the mesh product used for this purpose. Requiring clinical evidence of effectiveness and safety for POP and not for urinary incontinence could result in off-label use of the SUI product for both purposes, subverting the safety policies that this proposed order intends to put into place.”
A comment letter from the National Center for Health Research echoes strong support for the POP order and expresses concern that there is no proposed reclassification of surgical mesh for SUI.
“Surgical mesh is a permanent implant, failure of which can and has caused serious adverse health consequences for hundreds of thousands of women and men,” the letter says. “Reclassification of mesh for POP and SUI to Class III and requiring well-designed, long-term studies is essential to ensure that all transvaginal surgical mesh products are safe and effective.”
Finally, 11 members of the Patient, Consumer, and Public Health Coalition comment that the change “will help to ensure that devices intended to improve women’s health are supported by evidence of safety and effectiveness.” It, too, voices support for reclassification of SUI mesh and surgical instruments.
Jim Dickinson is MD+DI's contributing editor.
[image courtesy of AMBRO/FREEDIGITALPHOTOS.NET]