There is very little difference between pelvic mesh and hernia mesh. Doctors used both to improve the results of surgery. In many cases, pelvic mesh and hernia mesh were from the same manufacturers. Both pelvic mesh and hernia mesh were associated with complications. In fact, the makers of pelvic meshes ended up paying millions of dollars in settlements and were pulled from the market; hernia meshes may meet the same fate.
What are Pelvic Meshes and Hernia Meshes?
Also known as transvaginal mesh, pelvic is a plastic net-like product that provides extra support to weakened tissues. It is used to treat pelvic organ prolapsed and stress urinary incontinence. Surgeons place pelvic mesh via the vagina.
Hernias occur as the result of weaknesses or openings in the connective tissue or muscles that surround the abdomen. The intestines or other internal organs can push through these openings to cause. Over time, the openings can get larger to allow more of the organ to push through. In some cases, the opening can trap part of an intestine – this requires emergency medical attention.
Surgeons can repair hernias by pushing the organ back in place and surgically closing the opening. The existing weakness in the muscles or connective tissue can allow the hernia to redevelop.
Hernia mesh supports damaged tissue around hernias after surgery to help prevent the hernia from coming back. Surgeons place the mesh across the hernia repair site, securing it in place with stitches, staples, or glue. Following surgery, new tissue grows into the open pores of the mesh. This creates a sturdy support structure for the tissue.
Whether it is used for hernia repair or for pelvic organ prolapse, surgical mesh is usually made of polypropylene, a chemical compound that originated from the oil industry and found its way into many products in the 1950s. By the 1970s, medical professionals began to use propylene hernia mesh to treat pelvic organ prolapse and other medical problems.
The US Food & Drug Administration (FDA) used its 510 (k) fast-track process to approve the pelvic mesh. The 510 (k) fast-track process bypasses the rigors of human testing of a medical device if the manufacturer can prove that the device is substantially similar to one already available on the market. Unfortunately, this process does not take recalls or patient claims into account; instead the approval rushes the product to the market for immediate use. In the case of pelvic meshes, the manufacturers claimed it was similar to hernia meshes.
Lawsuits and Settlements Associated with Pelvic Mesh
On April 16, 2019, the FDA issued an order that requires all manufacturers of pelvic mesh to stop selling and distributing their products in the United States, effective immediately. The FDA determined that the manufacturers had not demonstrated a reasonable assurance of safety and effectiveness for the pelvic mesh devices.
To keep the devices on the market, the manufacturers had to prove that surgery to correct pelvic organ prolapse (POP) with pelvic mesh had better outcomes than surgery to correct POP without pelvic mesh. When the manufacturers failed to provide this proof, their pelvic mesh implants were pulled from the market. In 2022, pelvic mesh implant manufacturers Johnson & Johnson reached a $300 million settlement.
As with the pelvic meshes, there are now several class action lawsuits against hernia meshes. Abnormally high failure rates make it likely that the pelvic meshes will be pulled from the market. The product’s similarities to the failed and banned pelvic meshes may also be the downfall for hernia meshes.
While pelvic mesh and hernia mesh implants are slightly different, they are basically the same product and subject to the same regulations.