Complications from hernia mesh have been seen in a number of patients, and exist due to recalls and uncomfortable side effects from mesh that remains on the market.
According the FDA, common side effects of hernia mesh surgery include:
- Pain and bleeding
- Hernia recurrence
- Mesh shrinkage
- Intestinal blockage
- Organ perforations
- Nerve damage
- Autoimmune reactions to mesh
- Mesh migration and rejection
- Tenderness at implant site
Multiple types of hernia mesh have been recalled by the FDA for reasons such as pain, infection, recurrence, adhesion, obstruction and perforation.
Dealing with the negative effects hernia mesh may have caused a patient can sometimes require surgery that is more invasive than the original hernia surgery. Removing recalled mesh can be a complicated procedure.
Hernia Mesh Recalls
The FDA has issued several recalls for hernia mesh, many being Class I recalls meaning the products can result in injury leading to death.
Atrium Medical Corporation, now a part of the Maquet Getinge Group, designed a line of surgical mesh for hernia repaired called C-QUR. The FDA approved the non-absorbable polyethylene plastic mesh in 2006. It was differentiated from other mesh on the market by being coated with Omega-3 fatty acid fish oil, which was supposed to prevent inflammation and scarring from tissue sticking to the mesh. However, studies proved that it caused higher rates of infection and adhesion. In 2013, a recall for the C-QUR Edge Mesh was issued.
Bard Davol Inc., made the Kugel Hernia Patch and acquired FDA approval 1996. A synthetic mesh made of monofilament polypropylene allowed surgeons to fold the patch before implantation and a memory recoil ring let the patch open to its full shape once inside the cavity. The Kugel Hernia Patch led to complications when the implant ring was broken or bent and caused the implant to move, resulting in bowel blockage and punctures. The FDA listed the possibility of fistulas and bowel perforation in its recall.
In 2010, a safety investigation was launched into counterfeit polypropylene surgical mesh, and a Class I recall was issued for mesh sheets labeled with the C. R. Bard/Davol brand name. RAM Medical Inc., issued a voluntary recall of its surgical mesh for the same reasons.
Two brands of hernia mesh, Physiomesh and Proceed, manufactured by Johnson & Johnson’s Ethicon were either recalled or taken of the market by the company. Proceed was recalled by Johnson & Johnson on three separate occasions: January 2006, January 2011 and April 2014 for incomplete seals that could lead to sterilization issues. Physiomesh was pulled from the market in 2016, with the company citing higher than average rates of recurrence compared to its competitors.