In a recent study, patients who have undergone hernia surgery are reported to be at risk for complications they may not have otherwise had. The study appeared in the Journal of the American Medical Association (JAMA) in October 2016. Researchers noted that hernia mesh surgery patients typically had a lower risk of hernia recurrence over five years, but the use of prosthetic mesh to support the repair may cause complications that outweigh the benefits of the procedure.
Surgical Hernia Mesh Background
Surgical mesh to repair hernias has been used for decades. In 2012, about 190,000 abdominal hernia surgical repairs were performed in the U.S. and approximately half of them used a prosthetic mesh in the procedure.
The JAMA study revealed records examined by researchers from over 3,200 patients who underwent elective surgery repair in Denmark between 2007 and 2010. Some used hernia mesh, others used no mesh. In the five-year follow-up time-frame, researchers saw a number of complications that were mesh-related. Patients’ revealed reports of bleeding, abscesses, bowel perforation, and bowel obstruction.
Researchers remarked that with mesh-based repairs, 5.6 percent who underwent open surgery experienced complications, compared to 3.7 percent who underwent laparoscopic surgery. Patients who had non-mesh repair had a much lower complication rate at 0.8 percent, according to researchers.
Parker Waichman LLP is a national personal injury law firm with decades of experience representing clients in lawsuits regarding medical devices, including transvaginal mesh, bladder slings, and metal-on-metal hip implants, as well as hernia repair mesh implants.
FDA Hernia Mesh Approval
The complete range of benefits and risks linked with hernia mesh is not completely known, partially due to a fast-track U.S. Food and Drug Administration (FDA) approval process. The majority of mesh implants qualify for expedited FDA approval under the 510(k) approval process. Manufacturers need only to show that the devices are “substantially equivalent” to a previously FDA approved product. This permits new products to be on the market faster.
This process allows for the newer product to forego the stringent clinical trials that other new products must go through. Researchers say that because most mesh implants qualify for 510(k) approval, there’s not much relevant clinical data concerning the implants’ benefits and risks.
Ethicon Hernia Mesh Removed from the Market
The Physiomesh Flexible Composite Mesh made by Ethicon Inc., a subsidiary of Johnson & Johnson (J&J) after over six years on the market was withdrawn on May 25, 2016, because of a high rate of reported complications.
The Physiomesh hernia patch as described by Ethicon is a “sterile, low profile, flexible composite mesh designed for repair of hernias and other fascial deficiencies.” It is manufactured with a macroporous polypropylene. The Ethicon mesh implant had been approved through the 510(k) process.
The Physiomesh is implanted in patients who have opted for minimally invasive abdominal and groin hernia repair. In the company’s “Urgent Field Safety Notice,” Physiomesh was associated with higher rates of recurrence and reoperation when compared to other hernia mesh products. The safety notice was based on data from two big independent hernia registries, one in Germany and the other in Denmark.
Follow-up surgery was indicated to repair complications for many patients who had been implanted with that particular mesh. Some complications involving the Physiomesh device were abdominal pain, swelling, adhesions, bacterial infections, and migration of the mesh. Some patients experienced a recurrence of their hernias and required additional surgical repair.
A number of patients who suffered hernia mesh complications after implantation with a Physiomesh implant have filed lawsuits. Plaintiffs allege that Ethicon neglected to sufficiently warn them about potential complications and risks. Plaintiffs maintain that Ethicon allowed the Physiomesh to remain on the market longer than it should have, despite reports of complications that often required additional surgeries.
Hernia Mesh Lawsuits
Some of the allegations concerning hernia mesh lawsuits over failed Physiomesh hernia mesh products include: failure to perform sufficient research of the product; failure to warn about the complications associated with the product; providing misleading information regarding Physiomesh’s safety; defective instructions for surgeons; failing to make a safer mesh product.
One lawsuit was filed in the U.S. District Court, Middle District of Florida on September 22, 2016, according to court records. Another Physiomesh lawsuit filed in the Southern District of Illinois is scheduled to start trial on January 22, 2018.
Legal Help Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries associated with the use of a hernia mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please contact Parker Waichman attorneys at 1-800-YOURLAWYER (1-800-968-7529).