Public Citizen, the consumer advocacy group that years ago called for tighter restrictions on a type of surgical mesh used to treat pelvic organ prolapse, called the FDA’s latest proposal to increase oversight on the products “troubling both in its scope and timing.”
The group said in a statement that the government agency waited too long to act and that its recommendations may still put women at risk.
Here’s the full statement from Public Citizen’s Health Research Group Director Michael Carome on the FDA’s latest proposal:
Public Citizen welcomes…[the] long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. Such an order would implement one of three actions requested in Public Citizen’s August 25, 2011, petition to the FDA, which also requested an immediate ban and recall of all such devices currently on the market.
However, the FDA’s action today is troubling both in its scope and timing. First, the agency acknowledged that the safety and effectiveness of surgical mesh for transvaginal repair of POP has not been established and that these devices frequently cause serious adverse events. But the agency has taken no action to immediately remove currently available products from the market, as we requested in our petition, or to warn physicians and patients to stop using these devices.
Second, it is disturbing that the agency has taken so long to begin the regulatory process to reclassify surgical mesh for transvaginal repair of POP – [this week's] action comes nearly three years after our petition and after an FDA advisory committee recommended such action. Moreover, the proposed timeline for full implementation of the FDA’s order, if finalized, will take several more years.
As a result of the FDA’s reckless delays and inadequate action regarding surgical mesh for transvaginal POP repair, thousands of women will continue to be unnecessarily exposed to a wide array of serious risks, many of which can permanently alter women’s quality of life.
The Wall Street Journal reports that drug giant Johnson & Johnson, one of the manufacturers of this type of surgical mesh “no longer has any products on the market that would be affected by the new recommendation” and another manufacturer, Boston Scientific, continues “to work with the U.S. Food and Drug Administration to ensure appropriate information regarding mesh products is provided to patients and doctors.”