After Pelvic Mesh Lawsuits, FDA Seeks Stricter Rules
An avalanche of pelvic mesh suits has prompted the FDA to seek stricter safety rules for makers of the problematic implants.
Pelvic mesh, also known as transvaginal mesh, has been used for more than 15 years to repair patients' pelvic walls in cases of pelvic organ prolapse -- where organs slip through the pelvic wall and into the vagina. This condition can occur in older women and post-pregnancy, and it can lead to "embarrassing bladder leaks," reports The Associated Press.
Do these new FDA rules mean the end of pelvic mesh implants?
FDA Proposes Classifying Pelvic Mesh as 'High-Risk'
The U.S. Food and Drug Administration (FDA) has authority to regulate all medical devices, including pelvic mesh. When approving a medical device for use in the U.S., the FDA classifies the device based on its potential risks and uses. The three classes are:
- Class I (low-risk),
- Class II (moderate-risk), and
- Class III (high-risk).
According to the FDA, Class III devices require a showing of safety and effectiveness before they can be marketed. Pelvic mesh used to be classified as a Class II device, but the multitude of mesh-related lawsuits has convinced the FDA otherwise.
In a press release Tuesday, the FDA announced it would seek to reclassify transvaginal mesh as a Class III device and propose requiring its manufacturers to submit to premarket approval for safety and effectiveness. Like other FDA proposals, the changes will be available for public comment for 90 days before they become final and effective.
Is Pelvic Mesh Still Available?
Large surgical mesh manufacturers like C.R. Bard have seen millions of dollars in losses due to transvaginal mesh suits, and there are many women who may still suffer from pelvic mesh injuries.
And it isn't just big medical companies feeling the hurt. Doctors who improperly implant the mesh or fail to disclose its risks may also face suit for medical malpractice or medical battery.
Despite the possibility of litigation over its use, until the FDA rules go into effect, transvaginal mesh may still be sold by its manufacturers and is available for physicians treat pelvic organ prolapse.
Related Resources:
- Medical Devices: Surgical Mesh; Transvaginal Pelvic Organ Prolapse Repair and Surgical Instrumentation; Urogynecologic Procedures; Reclassification; etc. (FederalRegister.gov)
- 1st Federal Transvaginal Mesh Verdict: $2M (FindLaw's Injured)
- Transvaginal Mesh Injury Overview (FindLaw)
- Browse Drug & Medical Devices Lawyers by Location (FindLaw)