The FDA, in the 1990s, classified the first POP and SUI mesh as Class II after deciding these products were “substantially equivalent” to older surgical meshes. This, of course, proved not to be the case.20 The FDA started receiving thousands of reports of adverse events and, in 2008, warned physicians to be vigilant for adverse events from the mesh. The FDA’s notification recommendations regarding mesh included the following13:
- Obtain specialized training for each mesh implantation technique, and be cognizant of risks.
- Be vigilant for potential adverse events from mesh, including erosion and infection.
- Be observant for complications associated with tools of transvaginal placement (ie, bowel, bladder, and vessel perforation).
- Inform patients that implantation of mesh is permanent and complications may require additional surgery for correction.
- Be aware that complications may affect quality of life—eg, pain with intercourse, scarring, and vaginal wall narrowing (POP repair).
- Provide patients with written copy of patient labeling from the surgical mesh manufacturer.
In 2011, the FDA issued a formal warning to providers that transvaginal mesh posed meaningful risks beyond nonmesh surgery. The FDA’s bulletin draws attention to how the mesh is placed more so than the material per se.19,21 Mesh was a Class II device for sacrocolpopexy or midurethral sling and, similarly, the transvaginal kit was also a Class II device. Overall, use of mesh midurethral slings has been well received as treatment for SUI. The FDA also accepted it for POP, however, but with increasingly strong warnings. The FDA’s 2011 communication stated, “This update is to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare….Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”7,13
In 2014 the FDA proposed reclassifying mesh to a Class III device, which would require that manufacturers obtain approval, based on safety and effectiveness, before selling mesh. Not until 2016 did the FDA actually reclassify the mess as Class III. Of course, during this time, mesh manufacturers were well aware of the substantial problems the products were causing.13
After serious problems with mesh became well known, and especially after FDA warnings, the use of mesh other than as indicated by the FDA was increasingly risky from a legal (as well as a health) standpoint. As long as mesh was still on the market, of course, it was available for use. But use of mesh for POP procedures without good indications in a way that was contrary to the FDA warnings might well be negligent.
Changes to informed consent
The FDA warnings also should have changed the informed consent for the use of mesh.22 Informed consent commonly consists of the following:
- informing the patient of the proposed procedure
- describing risks (and benefits) of the proposed process
- explaining reasonable alternatives
- noting the risks of taking no action.
Information that is material to a decision should be disclosed. If mesh were going to be used, after the problems of mesh were known and identified by the FDA (other than midurethral slings as treatment of SUI), the risks should have been clearly identified for patients, with alternatives outlined. The American College of Obstetricians and Gynecologists Committee on Ethics has 8 fundamental concepts with regard to informed consent that are worth keeping in mind23:
- Obtaining informed consent for medical treatment and research is an ethical requirement.
- The process expresses respect for the patient as a person.
- It protects patients against unwanted treatment and allows patients’ active involvement in medical planning and care.
- Communication is of paramount importance.
- Informed consent is a process and not a signature on a form.
- A commitment to informed consent and to provision of medical benefit to the patient are linked to provision of care.
- If obtaining informed consent is impossible, a designated surrogate should be identified representing the patient’s best interests.
- Knowledge on the part of the provider regarding state and federal requirements is necessary.
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