Vaginal mesh continues to be making headlines lately, joining the ranks of products like metal-on-metal hip implants, which attract scores of lawsuits. Last year, a California jury awarded $5 million to a plaintiff in the first major transvaginal mesh lawsuit, which centered around Bard Medical’s Avaulta mesh. Only today, a New Jersey court handed out $3.35 million in a case related to Ethicon’s Gynecare Prolift mesh. That case was the first of more than 1800 that are pending in New Jersey against Ethicon.
|The adverse event patient outcome trends graph for polymeric surgical meshes by Johnson & Johnson shows a steep spike in 2012. The numbers in blue represent adverse events requiring intervention.|
While there has been poor reporting of adverse events related to the Gynecare meshes, there was a considerable spike in the number of reported problems linked to polymeric surgical meshes in 2012. (Gynecare meshes are themselves submitted under two classifications: OTN – “Gynecologic Surgical Meshes for Female Stress Urinary Incontinence” and OTP –“Transvaginally Placed Gynecologic Surgical Meshes for Pelvic Organ Prolapse”.) “In 2012, only infusion pumps and metal-on-metal hip implants beat [polymeric surgical mesh] in terms of number of reports for a particular device category,” says Nora Iluri, PhD, founder of Clarimed and DeviceMatters, which compile post-market safety-related data for medical devices. “This category was the eighth greatest source of adverse events for J&J in 2011 (out of 602 product categories that J&J launched devices in).”
Sorting the top brand names that were categorized under polymeric surgical meshes revealed that many of these products were Ethicon's Gynecare products or the Prolift product for pelvic floor repair.
The most common reason quoted for failure in the past two years was material erosion, which was a problem in 894 of the events. The second most common reason for failure was tears and holes in the devices, which was cited in 39 cases, followed by material perforation in 22 cases.
The DeviceMatters data also found an overall uptick in serious adverse events across manufacturers of polymeric surgical meshes. Between 2008 and 2011, the number of serious adverse events with patient outcome reports grew from 299 to 914, representing a 206% increase over three years.
- Five Common Causes of Medical Device Failure
- Serious Adverse Events Triple in Three Years: Is Risk or Reporting to Blame?
- Conformal Coatings for Tomorrow’s Medical Technologies - Webcast
- ISO80369 Standards Bring Changes to Medical Device Companies - Webcast
- Automation in Machining - Webcast
- How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance - Webcast
- 3 Tips for Successfully Launching an Outsourced Medical Device - Webcast
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast