The U.S. Food and Drug Administration (FDA) has rejected a request from Public Citizen, the consumer advocacy group, to order recalls of existing surgical mesh products and ban their future sale. The FDA takes the position that a recent proposal to more rigorously review the devices is sufficient for now. In its response to a 2011 petition from Public Citizen, the FDA noted that it proposed earlier this year to require premarket approval of surgical mesh products used for transvaginal repair operations.
As we have reported, these devices have been the subject of thousands of lawsuits alleging serious side effects, such as pain and incontinence, and have caused tremendous problems for a huge segment of the female population in the U.S. For years the mesh products have been cleared for sale along the less-arduous 510(k) approval pathway. I am convinced that a recall was in order and that the FDA was wrong in refusing to grant the petition.
The FDA has refused to go further by ordering recalls or banning the mesh products outright. But it did decline to totally shut the door on such enforcement, writing that it “may consider future action against individual products or this product type as appropriate.” Hopefully, that’s not just a typical FDA response to a serious problem. The response also noted that some manufacturers may not be able to satisfy the stringent safety and effectiveness standards of premarket approval. It’s certainly possible, as the FDA indicated, that some companies may not even bother trying to meet the standards.
Public Citizen’s petition had urged the FDA to adopt the premarket approval requirement for new mesh products. While the agency for technical reasons did not formally grant that request, regulators said their proposal earlier this year “initiated the process that could ultimately result in the action you seek.”
Michael Carome, director of Public Citizen’s Health Research Group and the petition’s author, stated that his group welcomes the move, but that he remains troubled by the lengthy process surrounding stricter oversight of mesh devices. It should be noted that the FDA first voiced concerns in 2008. It could be several more years from now before the proposed order on premarket approval is finalized and new clinical trials are performed to gauge whether products should stay on the market. Considering how truly bad the mesh products are, that is totally unacceptable. Carome observed:
Obviously we were pleased that they were taking this step, but we know that this is a long overdue action, and we found it disturbing that it had taken so long.
In order to ban a medical device, the FDA is required under federal law to find that the product “presents substantial deception or an unreasonable and substantial risk of illness or injury.” While regulators said in their response that they still believe sufficient benefits exist as compared with nonmesh surgical repairs, Carome accused the FDA of being too timid and said that enough evidence exists to halt sales. He said that the FDA, a regulatory agency all too often bows to the interests of corporations and doesn’t act in the interests of patients and public health.
Comments were being accepted on the FDA’s premarket approval proposal through July 30. Debate is also underway in Europe, where scientists have been tasked with re-evaluating the risk-benefit balance of mesh products and Scotland’s health secretary in June requested a temporary halt to sales of the devices.
If you need more information on this subject, contact Leigh O’Dell, a lawyer in our firm’s Mass Tort’s Section, at 800-898-2034 or by email Leigh.Odell@beasleyallen.com. Leigh has become quite knowledgeable because of her involvement in the ongoing mesh litigation. You can also contact Public Citizen by going to www.citizen.org for more information.
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