I am Dr. Dana Casciotti, and I am pleased to read the statement of Dr. Diana Zuckerman, president of the National Research Center for Women & Families. Our Center does not accept funding from device companies, and therefore has no conflict of interest. Although Dr. Zuckerman has stock in Johnson & Johnson, her statement is critical of all surgical meshes, including J & J’s.
Our nonprofit Center analyzes and reviews research on a range of health issues, and provides objective and understandable information to patients and providers. Dr. Zuckerman’s perspective is as a former faculty member at Vassar and Yale and researcher at Harvard, who was trained in epidemiology at Yale Med School. She is also currently a fellow at the University of Pennsylvania Center for Bioethics, and she is on the Board of the Alliance for a Stronger FDA, a coalition which lobbies for more resources and funding for the FDA.
Over the last decade, Dr. Zuckerman has spoken with many men and women who have suffered greatly from complications from surgical mesh used in the treatment of incontinence.
We agree with the FDA that serious adverse events from mesh are NOT rare. No man or woman wants to suffer from incontinence, but the terribly painful complications can be much worse than the incontinence that initially led to surgery. And, those complications are often impossible to repair.
As you know, the nearly 1,400 serious adverse reports in the last 3 years include deaths, and the most common are pain, erosion, infection, urinary incontinence and related problems, and organ perforations. These mostly voluntary reports are just the tip of the iceberg.
We agree with the FDA that there is evidence that mesh can be effective for incontinence, but too little is known about which types of mesh work best and under what circumstances. There are more than 100 different mesh products on the market for the treatment of incontinence. It is likely that some are better than others. But none were required to be proven safe or effective in clinical trials, so it is possible that some of these products are not safe or effective, some are safe but not effective, some are effective but not safe, and some are neither.
Therefore, the effectiveness of some of these products is not a good reason to continue to review all of them under the 510(k) process. Because of the unknown risks and benefits of specific mesh products, all surgical mesh for incontinence should be reclassified as Class III. The more stringent PMA review is needed for each specific device to determine whether the benefits outweigh the risks, and if so, for which women.
In contrast, the PMA process does evaluate the safety and effectiveness.
The PMA process has several major advantages compared to the 510(k) process:
1. The PMA process requires clinical trials to determine safety and effectiveness of each product.
2. It includes the inspection of manufacturing facilities. That would ensure the appropriate manufacturing of surgical mesh.
3. PMA applicants can be required to conduct post-market studies. Post-market studies evaluate long-term safety and effectiveness, and help determine how well the mesh works in the real world.
Patients have been severely harmed by mesh that was not tested in clinical trials. In addition to medical problems, the financial costs are enormous, with many women and men requiring multiple additional surgeries and yet never fully recovering.
If the FDA were to reclassify mesh for incontinence as Class III, each mesh device would need to be proven safe and effective based on its own data, not the data of other mesh products.
Although the FDA points out that there is evidence of effectiveness – but that evidence is not specific to each mesh device.
Class III devices are defined as higher risk. Most implanted devices can cause substantial harm to patients if they fail, and that is why so many implanted devices are Class III. Logically, the risks from mesh erosion and severe local complications qualify surgical mesh as a Class III device. If each company submits data from clinical trials for their specific device, the FDA will be able to determine which mesh products have benefits that outweigh the risks. In addition, the ability to call for inspections and post-market studies, which are part of the PMA process but not the 510(k) process, will greatly improve patient safety.
Reclassifying mesh for incontinence to Class III would protect patients and enable their physicians to make treatment recommendations based on scientific data for specific mesh products.
We therefore respectfully ask you to urge the FDA to reclassify mesh to Class III. We believe that the best comparison for clinical trials would be with a non-mesh surgical control arm.
Reclassification takes a long time. What can you do to protect patients in the meanwhile?
1. Recommend that the FDA require companies that want to keep their mesh on the market to immediately start clinical trials to prove safety and effectiveness for incontinence
2. To provide useful data more quickly, the FDA should encourage companies with mesh already on the market to submit well-designed retrospective studies of patients who had incontinence surgery at least 3 years ago. They should compare the outcome for patients whose surgery included mesh with those whose surgery did not include mesh. This would provide better long-term data more quickly than a prospective study.
3. Meanwhile, 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 mesh for the treatment of incontinence has not been established and is currently under study.”
We have not asked for a recall of mesh for incontinence, because there is evidence that it has benefits. However, it is in the interest of public health to have evidence of safety and effectiveness of specific products, not just mesh in general.