Prolift Transvaginal Mesh Introduced Without FDA Pre-Market Clearance: Report

Washington, DCExpert insight from a witness in a recent transvaginal mesh lawsuit provides a revealing look into how some products reach the market prior to evolving to become a thorn in the side (or elsewhere) for a patient having undergone a surgical procedure in good faith with a device presumed to be safe.

In late May, plaintiff Sharon Beltz was awarded $2.16 million in compensation for pain and suffering transvaginal mesh complications associated with an allegedly defective Prolift mesh manufactured by Ethicon, a unit of Johnson & Johnson.

Beltz, according to court records, dropped a few of her claims against Ethicon along the way (such as loss of consortium), and even though there were no punitive damages awarded, the trial jury in the end awarded the transvaginal mesh lawsuit plaintiff over $2 million.

Jurists at the trial heard expert opinion from Dr. Peggy Pence PhD, an expert witness who produced a report heard at trial. In her report, Dr. Pence characterized Prolift as misbranded and adulterated due, according to Pence, to a lack of what was described as inadequate pre-market clearance as required through the 510(k) Clearance protocol maintained by the US Food and Drug Administration (FDA) at the time of Prolift’s launch in 2005.

According to court documents a previous Ethicon product – the Gynecare Gynemesh PS – had itself been approved by the FDA through a 510(k) Clearance, which meant the Gynemesh PS was considered substantially equivalent to a product previously approved, already on the market and performing satisfactorily.

However, the Gynecare Prolift Pelvic Floor Repair System was characterized by Ethicon as a line extension of the Gynecare Gynemesh PS. Prolift, according to that pathway, proceeded to market in March 2005 without a 510(k) Clearance. It is alleged, therefore, that the FDA wasn’t notified of the existence of Prolift.

Pence noted in her expert report that the pre-cut Prolift surgical mesh was manufactured from the same non-absorbable polypropylene material used for Gynemesh PS. There were two, non-randomized and non-controlled studies undertaken by Ethicon in 2004 – the year before Prolift was launched – in order to evaluate the product. Studies, according to Pence, were also conducted at eight sites in France and three sites in the US. Twenty percent of study participants in the French study experienced dyspareunia (painful intercourse). Overall, 25.6 percent of participants in the French study experienced transvaginal mesh complications, with 65.9 percent of patients in the US experiencing similar adverse events.

With those study results, Ethicon Prolift entered the market in 2005 without an FDA 510(k) Clearance. Ethicon, according to court records, noted that the Prolift transvaginal mesh was exempt from 510(k) premarket clearance due to the fact Prolift was a custom device.

Pence, in her expert report, took exception to that characterization, noting that neither the Prolift device, or instruments designed for Prolift application were custom devices and thus were not exempt from compliance with requirements inherent with the 510(k) premarket notification.

“Ethicon marketed a product that violated safety and ethical standards,” she concluded.

Earlier in the spring – in late May – a federal judge in West Virginia dismissed 97 transvaginal mesh lawsuits that were characterized as having been compromised, and thus were settled. Terms of the settlements, which were supervised by US District Court Judge Joseph R. Goodwin. Nor was there any insight as to the reasons why, or circumstances involved, in the lawsuits having been compromised.

There remain thousands of transvaginal mesh lawsuits pending, nonetheless.