Untested Pelvic Mesh Highlights Concerns Over FDA Process (cont.)

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News sources say that, according to the FDA, in 2010, doctors performed more than 100,000 prolapse repairs using surgical mesh, and about 75 percent of them were transvaginal. Between 2005 and 2007, the agency received more than 1,000 reports of adverse events related to the mesh in women diagnosed with pelvic organ prolapse or stress urinary incontinence. From 2008, when the FDA first announced the safety concerns surrounding the device, to 2010, the FDA received almost 3,000 more.

The agency stated, “Although it is common for adverse event reporting to increase following an FDA safety communication, we are concerned that the number of adverse events reports remains high.”

But that doesn’t mean that the agency plans on pulling the device form the market. Dr. William Maisel, deputy director and chief scientist at the FDA’s Center for Devices and Radiological Health, said, “We don’t think transvaginal mesh should be routinely used for pelvic organ prolapse repair. But we do not regulate the practuce of medicine, and we do recognize that some patients really do need mesh.

Urogynecologist with the University of Utah, Dr. Ingrid Nygaard, claims she sees roughly two new patients a week with complications from mesh. Some are unable to be successfully treated, and according to her, “that’s a big tradeoff for a procedure that has uncertain effectiveness.” She said that surgeons that implant mesh generally mean well, because other procedures have a 10 to 20 percent failure rate.

Dr. David Grimes, who is board certified in obstetrics, gynecology and preventative medicine and a distinguished scientist at the global development organization FHI360, is less certain about the nobility of surgeon’s intentions.

“The problem is the surgeons,” Grimes said. “This is industry-driven technology. We have a long history of accepting things without critical appraisal. What we need are better standards not just within the FDA, but within the professional community.”

But conducting studies of devices like surgical mesh can be huge, lengthy and expensive tasks. Grimes said, “It’s easier to do studies of pills than it is to do studies of surgical techniques.”

Urogynecologist at the Washington Hospital Center in Washington, D.C. Dr. Cheryl Iglesia attempted such a study but was forced to cut it short. She and coauthors published their findings from a trial where they randomly assigned 65 women to transvaginal repair of prolapse with or without mesh in the journal Obstetrics & Gynecology last year. They found that after three months, the mesh had eroded in almost one in six of the women that received it. In addition, cure rates and quality of life were no different between the mesh and no-mesh study groups. This prompted questions as to the value of the device in such procedures.

A spokesman for the mesh manufacturer Ethicon, a Johnson & Johnson company, said that mesh is “an important option for many patients” when treat pelvic organ prolapse and stress urinary incontinence. Ethicon spokesman Matthew Johnson said, “Potential complications and risks are disclosed in our product labeling and discussed in our professional education and promotional literature.”

A registry of transvaginal mesh patients is in the works, however, in order to avoid skewing the data towards patients with complications, patients like Janet Holt and tens of thousands of other women already living with complications from surgical mesh will be left off.

As a Los Angeles wrongful death attorney, I hope this has helped shed some light on a very important subject.