I am Brandel France de Bravo, and I am pleased to have the opportunity to speak on behalf of the National Research Center for Women & Families. Our Center does not accept funding from device companies, and I have no conflict of interest.
Our nonprofit Center is focused on reviewing and synthesizing research on a range of health issues, and providing objective, comprehensive, and understandable information to patients and providers. My perspective is as someone trained in public health at Columbia University, with over 20 years of experience working on issues related to women’s health. In addition, I have heard first hand from women who have suffered painful and debilitating complications from surgical mesh.
We share the FDA’s concern that serious adverse events are NOT rare, and that there is no conclusive evidence that transvaginally placed mesh in POP repair provides clinical benefit compared to surgical repair of POP without using mesh. And, the mesh itself can cause terrible complications that are often impossible to repair.
There is no doubt that the 1,503 adverse reports- including several deaths-that were associated with POP repairs, are the tip of the iceberg.
These mesh problems were not a secret. They were reported in the medical literature, including 110 studies of more than 11,000 women, which found that 10% of women undergoing transvaginal POP repair with mesh experienced mesh erosion within 12 months. One has to assume that the erosion statistics would have been even greater with longer follow-up.
Even if there were some patients whose POP was successfully repaired through surgery with mesh, that is not a good reason to continue to review mesh for POP under the 510(k) process. We agree with the FDA that POP mesh should be reclassified as Class III: the PMA process is needed for each specific device to determine whether the benefits outweigh the risks, and if so, for which women.
The PMA process has several major advantages compared to the 510K process for patient safety:
1. The PMA process requires clinical trials to determine safety and effectiveness. That is essential in the case of mesh for POP repair.
2. It includes the inspection of manufacturing facilities. That is essential for ensuring the appropriate manufacturing of surgical mesh.
3. The PMA process can include required post-market studies. Since pre-market studies tend to be short-term, post-market studies are essential for ensuring long-term safety and effectiveness, and for determining how well the mesh works in the real world with many different doctors and larger numbers of patients.
In retrospect, surgical mesh should not have been allowed to stay on the market with the very limited regulatory protections of the 510(k) process. Patients have been severely harmed as a result, both in terms of their health and their quality of life. In addition, the financial costs to the patient and to our medical system have been substantial, with many women requiring multiple additional surgeries and yet never fully recovering.
It is unusual for the FDA to change its regulatory requirements for a medical device, so when the FDA admits that the 510(k) process is not adequate for surgical mesh for POP procedures, it is because the research literature and the post-market surveillance are clearly indicating a very serious problem.
I urge you to support the FDA’s plan to reclassify mesh to Class III. We also believe that the best comparison for clinical trials would be with a non-mesh surgical control arm.
The FDA says reclassification will take a long time. What can you do to protect patients in the meanwhile?
1. Recommend that the FDA make this re-classification retroactive to include all POP meshes currently on the market
2. Meanwhile, to protect the health of patients and to improve public health, POP mesh should be recalled, based on current evidence that the risks outweigh the benefits.
3. Companies whose mesh has been recalled may not want to wait several years to submit a PMA based on prospective data. Therefore, the FDA should encourage companies with POP mesh already on the market to submit well-designed retrospective studies of women who have had POP surgery at least 3 years ago, comparing the outcome for women whose surgery included mesh with those whose surgery did not include mesh. This design would provide better long-term data in a shorter period of time than a prospective study.
4. During the period when these new regulations are being put in place, the FDA should send a “Dear Doctor” letter to all physicians and draft new labels for all surgical mesh, stating that “The safety and effectiveness of this vaginal mesh for POP repair has not been established and is currently under study.”
I assume that mesh companies will complain that an immediate recall and requirement for clinical trials places an unfair burden on them in an already difficult economy. We are sympathetic, but the FDA’s focus has to be on public health. Patients are being seriously harmed by these surgical mesh kits because companies have been selling them without ever having properly tested them.