Regulatory Focus™ > News Articles > 2019 > 2 > Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

Posted 13 February 2019 | By Ana Mulero 

Experts Call on CDRH to Consider Adverse Event Reports in Assessing Vaginal Mesh

A panel of outside experts convened by the US Food and Drug Administration (FDA) on Tuesday deliberated on available evidence and patient testimonies regarding the use of transvaginal mesh implants and advised the agency to consider adverse event reports when conducting premarket reviews.

The panel, which was largely compromised of medical doctors, heard from patients who experienced a range of health complications following implantation of the surgical mesh. This marked the second time FDA held an advisory committee meeting to consider regulatory actions needed to address the issue. As the body of medical device reports (MDRs) associated with the implants continued to grow since the last meeting convened in 2011, the implants were reclassified into class III.

Efforts to address concerns around the products indicated for anterior repair of pelvic organ prolapse (POP) trans-vaginally face certain barriers, including a lack of long-term studies. There only two manufacturers currently marketing three such implants in the US. The FDA-cleared implants include Boston Scientific’s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair Matrix, as well as Coloplast’s Restorelle DirectFix. Both manufacturers gave presentations at the panel meeting.

Patients described to the panel members how their lives took a turn after being implanted as it relates to their health, sexual activity and mobility. This has been evidenced by not just the growing body of MDRs to FDA’s Center for Devices and Radiological Health (CDRH) but also the nearly 100,000 patient lawsuits that have been filed across the US, resulting in millions of dollars in court settlements.

There has yet to be an FDA-issued large-scale recall, but some manufacturers voluntarily recalled and discontinued manufacturing of their transvaginal mesh products in recent years. These include C.R. Bard’s Avaulta Plus transvaginal mesh and the GyneCare product line from Ethicon, a division of Johnson and Johnson, which continues to face the largest number of lawsuits.

“My focus is to get mesh off the market,” said Lana Keeton, president and founder of the Truth in Medicine Incorporated, at the panel meeting Tuesday. “I’ve been focused on this for over 12 years.” This is due to the “severe harm to so many hundreds of thousands of women” caused by the mesh products, she said. She pointed to “14 or 15” reoperations she underwent to remove a portion of her stomach as likely the reason she survived after being implanted. Keeton also characterized treatment with these mesh products as “barbaric” and “medieval.”

Another patient argued her sex life with her husband had been destroyed post-implantation. “I was active. I rock climbed, went boating, jet skiing, horseback riding, ballroom dancing,” said Barbara Melling. “Everything has been destroyed and it’s not just me. People I’ve gotten to know in our groups have died,” she added. Boston Scientific offered an apology to patients who voiced such testimonies.

“On behalf of Boston Scientific and myself as a physician, I want to express my deepest sympathy and my sincere empathy for those women who have been harmed by surgical mesh therapies,” said Ronald Morton, a medical doctor at Boston Scientific’s urology division, during the panel meeting Tuesday.

Still, the manufacturers defended their products during the panel, citing data derived from the 2012 FDA-mandated postmarket surveillance studies under the agency’s authority of section 522 of the FD&C Act. Boston Scientific “firmly believes that the totality of clinical evidence supports the positive benefit/risk profile of its Uphold LITE and Xenform transvaginal mesh devices to treat pelvic organ prolapse,” the manufacturer concluded.

Yet Coloplast also advised on factors that fall outside the scope of 510(k) assessments on safety and effectiveness and benefit-risk profiles. These include device use history, the associated surveillance data and appropriate surgeon education. The panel of outside experts reached consensus on using at least some of these factors for evaluating the surgical mesh implants on the market.  

In preparation for the meeting, CDRH developed an executive summary on the relevant clinical and regulatory background of the currently marketed surgical mesh devices. This involved a search of the agency's MDR database from January 2008 through October 2018, which identified a total of 11,274 MDRs. These include “10,391 reports of serious injury, 806 reports of device malfunctions and 77 reports of death,” CDRH said.

A 2013 spike of 3,881 MDRs—attributed to regulatory actions—and the subsequent drop that is reportedly “suspected to be the result of many manufacturers electing to stop marketing their devices indicated for transvaginal repair of POP upon issuance of the 522 orders” is shown in the graphic below.

Mesh-MDRs.PNG

Following the 2011 panel meeting, FDA required of the manufacturers to submit premarket approval applications (PMA) for their mesh products as these had been originally cleared through the 510(k) process. Both manufacturers submitted PMAs before the July 2018 deadline and these are currently under review.

CDRH has yet to provide its position on the panel’s new recommendations. CDRH spokesperson Deborah Kotz told Focus the center does not comment on the meeting itself “as a general policy” but “will carefully consider all of the input provided” from the panel and public speakers during the meeting.

Categories: Regulatory News

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