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On January 4, the U.S. Food and Drug Administration (FDA) strengthened requirements governing surgical mesh for the transvaginal repair of pelvic organ prolapse (POP). W&L hails this action as vital to addressing safety risks posed by transvaginal mesh devices.
“Previously, transvaginal mesh products were classified as Class II moderate-risk medical devices, but the FDA has now reclassified them as Class III high-risk devices,” said Allan Zelikovic, who heads the W&L Medical Malpractice and Pelvic Mesh/Transvaginal Mesh units.
“This reclassification will help doctors and patients as they weigh surgical options to more clearly recognize the potential for injuries inherent to transvaginal mesh devices,” he added.
A long-standing concern when using surgical mesh for transvaginal POP repair is that surgical placement of the devices through the vagina exposes patients to risks greater than those of other surgical options.
“One among a number of such risks is that the mesh may become exposed and even protrude out of the vaginal tissue,” said Mr. Zelikovic.
W&L several years ago began accepting cases of injuries arising from the complications of transvaginal mesh surgery and has been aggressively championing the rights of injured patients ever since.
“You may be entitled to compensation if you underwent transvaginal mesh surgery for treatment of POP and subsequently experienced pain, pain during sexual intercourse, infection, bleeding, urinary problems or other problems,” Mr. Zelikovic said.
PMAs Required for Surgical Mesh in Vaginal Repair
In addition to reclassifying transvaginal mesh as Class III devices, the FDA is also now requiring transvaginal mesh manufacturers to submit a premarket approval (PMA) application to support their products’ safety and effectiveness.
The FDA said these manufacturers must submit PMA applications within the next 30 months. Federal law requires a 30-month deadline, although the manufacturers may submit prior to then, the FDA explained.
The FDA’s new orders affect all five companies currently engaged in the marketing of transvaginal mesh.
In announcing its actions, the FDA emphasized that they apply only to mesh devices marketed for transvaginal repair of POP, not for stress urinary incontinence, abdominal repair of POP and other indications.
The finalized orders were proposed in May 2014, the FDA said. Two years earlier, the FDA ordered transvaginal mesh manufacturers to conduct postmarket surveillance studies to address specific safety and effectiveness concerns.
The FDA indicated that these postmarket surveillance measures remain in effect. The FDA said ongoing postmarket surveillance is necessary to enable the agency to monitor how women with this device are faring months and years after surgery.
Rise In Reported Adverse Events Using Surgical Mesh
The earliest use of surgical mesh was for the repair of abdominal hernias. Twenty years later, beginning in the 1970s, surgical mesh came into use for the abdominal repair of POP.
Transvaginal repair of POP emerged in the 1990s. The first mesh device with this indication was cleared for use by the FDA in 2002.
The first FDA warning to doctors and consumers regarding the use of surgical mesh for transvaginal POP repair was issued in 2008. This was followed by a second warning in 2011.
Both warnings described an increase in adverse event reports related to mesh used for urogynecological procedures.
Following the second warning, the FDA convened an advisory panel to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair.
Since convening that panel, the FDA said it has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair.