Comments of the National Center for Health Research
Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation for Urogynecologic Surgical Mesh Procedures; Designation of Special Controls for Urogynecologic Surgical Mesh Instrumentation
[Docket No. FDA 2014-N-0297]
On behalf of the National Center for Health Research, I am pleased to have the opportunity to express our views on the proposed order on the reclassification of certain surgical mesh devices and surgical instruments. Our nonprofit Center analyzes and reviews research on a range of treatment issues, and provides objective and understandable information to patients and providers. My perspective is as a former faculty member at Vassar and Yale and researcher at Harvard, who was trained in epidemiology at Yale Med School. Recognizing the importance of the FDA, I am on the Board of Directors of the Alliance for a Stronger FDA, which lobbies for more resources and funding for the FDA and the Reagan Udall Foundation for the FDA.
Over the past 15 years, our Center’s staff has spoken with many women who have suffered greatly from complications from surgical mesh used in the treatment of POP or incontinence. We have also carefully scrutinized the scientific data on mesh and the MAUDE reports.
No woman wants to suffer from POP or incontinence, but the terribly painful complications of mesh can be much worse than the conditions that initially led to surgery. And, those complications are often impossible to repair.
We strongly support the FDA’s proposal to upclassify both surgical mesh for POP repair and surgical mesh instrumentation. The upclassification of mesh for POP would require mesh devices be tested in clinical trials to prove that they are reasonably safe and effective. We strongly urge that PMA studies provide long-term data that provide meaningful evidence of safety and effectiveness, since mesh is so difficult to remove.
We are, however, very concerned that the FDA has not yet proposed reclassification of surgical mesh for stress urinary incontinence (SUI) from class II to class III. 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. 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.
Reclassification of Surgical Mesh for POP Repair
We strongly support the FDA’s proposal to reclassify surgical mesh for POP repair from Class II to Class III, which is a scientifically sound proposal given the lack of evidence of health or quality-of-life benefits and the large number of serious adverse events in the MAUDE database. We also note that this is consistent with the recommendation of the Obstetrics & Gynecology Devices Advisory Panel in 2011. In the last 3 years, the FDA has received nearly 20,000 adverse event reports for surgical mesh for POP repair, including pain, erosion, infection, bleeding, painful intercourse, organ perforation, vaginal scarring, and permanent injury.
Class II general and special controls are not sufficient to ensure either the safety or the effectiveness of these devices. It may be that some specific mesh products are safe and effective, but clinical trials are needed to determine which, if any, satisfy those approval criteria.
Reclassification of Surgical Mesh Instrumentation
We also support the reclassification of surgical mesh instrumentation. The FDA reports there are also serious harms associated with the instrumentation used during procedures with surgical mesh, including damage to blood vessels, nerves, and tissue that may have been caused by improperly designed surgical mesh instrumentation, as well as infection that may have been caused by inadequate sterilization. Because instrumentation is currently class I, there is minimal regulation of these devices despite the fact that they are used in surgery and are causing serious harm to women.
We question whether upclassification to Class II 510(k) review is sufficient to determine the safety and effectiveness of mesh instrumentation, however. Clinical trials and inspections are needed to better protect women.
Reclassification Needed for Surgical Mesh for Urinary Incontinence
For the 3 years prior to the FDA’s 2011 review, MAUDE included 1,371 serious adverse reports for mesh for incontinence, such as pain, erosion, infection, and organ perforations. However, after more attention was brought to the issue, MAUDE reports skyrocketed. While the MAUDE reports on the FDA web site are difficult to decipher, it appears that there were more than 18,000 serious reports for stress urinary incontinence mesh devices (Product Code OTN) in 2013 alone. And, unfortunately, MAUDE reports are usually just the tip of the iceberg.
While there is evidence that mesh can be effective for incontinence, too little is known about which types of mesh work best and under what circumstances. There are at least 40 different mesh products on the market for the treatment of incontinence. It is likely that some are better than others. Since none were required to be proven safe or effective in clinical trials, it is possible that some of these products are neither safe nor effective, some are safe but not effective, some are effective but not safe, and some are both safe and effective.
Therefore, the effectiveness of some of these existing products is not a good reason to continue to review all new ones 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 2011, the Institute of Medicine concluded that “the 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices.” In our analysis of several recently approved mesh products, we found that all dated back to the ProteGen mesh predicate, which was recalled in 1999 because of its serious harm to patients.
Patients have been severely harmed by surgical mesh for incontinence because the mesh was not tested in clinical trials. In addition to medical problems, the financial costs are enormous, with many women requiring multiple additional surgeries and yet never fully recovering.
We strongly urge the FDA to reclassify mesh for incontinence to Class III, which would protect patients and enable their physicians to make treatment recommendations based on scientific data for specific mesh products.
An additional concern is that a split classification of mesh devices would create a loophole allowing surgical mesh used for other indications to be cleared through the 510(k) process as a mesh for urinary incontinence. Several FDA Advisory Panel members raised concerns about this in 2011, noting that companies could get new mesh products on the market more quickly and easily by applying for a SUI indication instead of a POP indication. That is an additional reason why transvaginal surgical mesh should be upclassified to Class III for all indications.
In conclusion, surgical mesh has had a devastating effect on the lives of many women because it has not been proven safe or effective in clinical trials. We strongly urge reclassification to Class III for surgical mesh for POP and incontinence, and a requirement of clinical trials and inspections for mesh instrumentation, to protect the lives and health of women.
Diana Zuckerman, PhD, President
National Center for Health Research