Food And Drug Administration Does Not Issue Warnings About Hernia Mesh
Jane Aker, a journalist and the current National News Editor for the Mesh News Desk (MND), posted an article for the Legal Examiner in January 2019. In her report, she calls into question the wisdom of the Food and Drug Administration’s (FDA) failure to warn people about the dangers of hernia mesh, given the history of similar surgical mesh which, in the past, has been proven to cause severe injuries to thousands of patients.
Some Background About Surgical Mesh
Surgical mesh has a controversial history. Between 2008 and 2018, the FDA investigated surgical mesh, which was used as a conventional treatment for pelvic organ prolapse (POP). The FDA determined that the mesh used to treat POP was dangerous. After initially concluding in 2008 that complications from surgical mesh were rare, the FDA reversed itself in 2011.
The increase in the number of injuries and complications caused the FDA to advise that POP surgical mesh is used “as a last resort because the benefits did not outweigh the risks.” After post-POP mesh monitoring, the FDA determined that POP mesh was to be classified as a class 3 medical device, which is one that involves the highest risk. Class 3 medical devices require clinical trials and clearance before they can be marketed to the public.
Hernia Mesh is Made From the Same Material as POP Mesh
According to Akers, hernia mesh is made from polypropylene, the same material as the POP mesh categorized as a class 3 medical device. The FDA, however, has not provided the public with updated information or warnings on its hernia mesh page since February 2018. The FDA activities page about hernia mesh has not been updated since 2017.
Manufacturers of hernia mesh have voluntarily recalled thousands of lots of these medical devices. According to Aker:
- Bard Davol recalled Composix Kugel mesh in 2005
- Ethicon’s Proceed surgical mesh was recalled in 2010
- Atrium C-Que Edge remains on the market, but one lot was recalled in 2013
- Ethicon’s Physiomesh was recalled in 2016
- Some Atrium ProLite Mesh was recalled in 2018
Despite these manufacturers removing hundreds of thousands of hernia mesh products from the market, “the FDA seems disinterested” Aker states. She points out that the FDA has acknowledged that some complications may occur because of recalled hernia mesh. However, the number of injuries and complications being reported by patients far outnumbers the recalled hernia mesh. Akers goes on to point out that 90% of hernia repair surgeries utilize hernia mesh, and the numbers just do not add up.
The FDA continues to make no movement toward warning patients of the numerous complications that are occurring at an alarming rate. Some of the injuries being reported are similar to those that happened with POP mesh:
- Organ perforations
- Bowel obstructions
- Adhesion of the mesh
- Mesh migration
- Piercing of tissue, muscle, organs
- Intestinal puncture
The injuries are severe and can result in the need for multiple surgeries to not only repair the damage from surgical mesh but to remove the device as well. Yet the FDA has not provided any real warnings about these dangers to the public or medical community.
Will Hernia Mesh Litigation Make the FDA Change Its Position?
There is currently litigation in state and federal courts across the nation involving several manufacturers of hernia mesh. Plaintiffs have filed lawsuits to hold them accountable for the pain, suffering, and expenses caused by hernia mesh implants. Bellwether trials are set for June and September 2019, and the outcome may result in new information that may sway the FDA’s classification of hernia mesh.
Contact Us if You Have Been Injured by a Hernia Mesh Implant
You may be eligible to file a claim to collect monetary damages for your injuries. Call Alonso Krangle, LLP at 516-350-5555 for a free consultation and evaluation of your hernia mesh case.