Hernia Mesh Research Questions Risk-Benefit Profile
Despite reports that question the benefits of abdominal—or hernia—mesh and that research continues to indicate that the risks of the medical devices may outweigh their benefits, mesh manufacturers are still selling potentially harmful hernia mesh products and surgeons continue to perform hernia mesh surgeries.
In fact, a study published in late 2016 in JAMA concluded that the “benefits attributable to mesh are offset in part by mesh-related complications.”
One man describes undergoing hernia repair surgery six years ago and alleges that he has been in extreme pain since. He says, “I’ve had many trips to the ER with recurring infections. It gets so bad that I can’t urinate or have bowel movements,” adding that, “This is a terrible way to live. I’ve already had two more surgeries to remove the mesh, to no avail.”
A women says that, “The day after my hernia surgery I felt pain but my doctor told me it would go away. Wrong. I had to have another surgery and they found the mesh all caught up in my intestines.” She added “That was two years ago and I get spasms in my abdomen all the time.”
Another man says “I had a hernia operation back in 2010, where a surgical mesh was used in the surgery and I incurred infections, recurrence of the hernia, more surgery to correct the problem, plus lengthy recuperations in the hospital and at home.” He also says that, “After the second operation performed by another surgeon, he told me that the mesh was stuck to the inside of my abdomen and that he had to literally scrape it off. The second surgeon also told me that this mesh was the largest piece of repair material he had ever seen. I believe this mesh was defective but no one is admitting it.”
When mesh infections occur, just about all of the hernia mesh must be completely removed to eliminate infection. According to the Mesh News Desk, hernia mesh infections are very difficult to cure because the infection develops into a biofilm. Biofilms function as an ecosystem of bacteria that covers the entire mesh. The United States National Library of Medicine reports that mesh-related complications have become much more more frequent. “Antibiotics and mesh-saving operations are not sufficient to eradicate the infection in the majority of cases.”
The hernia mesh lawyers at Parker Waichman LLP are offering free legal consultations to individuals who suffered injuries associated with the use of hernia mesh, including Ethicon’s Physiomesh, Atrium’s C-Qur mesh, and other mesh products.
Ethicon Physiomesh and Atrium C-Qur Recalls, Lawsuits
Ethicon, a subsidiary of Johnson & Johnson, issued a recall of its Physiomesh flexible composite hernia mesh product subsequent to reports of increased rates of hernia recurrence and revision surgeries that were greater than other mesh devices that are used for hernia repair. Ethicon advised healthcare providers of the problem in a May 2016 “Urgent Field Safety Notice.” Unpublished data from two large independent hernia registries—Denmark and Germany—also indicated that Ethicon’s Physiomesh Flexible Composite Mesh was tied to higher hernia recurrence and revision surgery rates when compared to the average rates of other similar mesh devices. Physiomesh contains polypropylene, which has been the focus of injury reports and lawsuits. Meanwhile, the device maker was unable to determine what caused the rise in Physiomesh reoperation rates and announced that, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.” Ethicon also wrote that, “Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market…. Ethicon will not return the Ethicon Physiomesh composite mesh product to the market worldwide.”
Physiomesh was fast-tracked in 2010 via the 501k route, which is a faster clearance process that enables device makers to release a device to market with no clinical testing if they are able to prove that the new product is substantially similar to a product that was previously approved by the U.S. Food and Drug Administration (FDA).
A woman filed a hernia mesh lawsuit against Ethicon in December 2016 in the U.S. District Court for the Middle District of Florida. She alleged severe complications after being implanted with Ethicon Physiomesh hernia mesh that included the plastic mesh adhering to vital organs. She also alleges that she underwent a revision surgery to have the mesh removed and that she suffered a recurrence of the hernia. The lawsuit also alleges that Ethicon Physiomesh was defectively designed, excessively dangerous for use in hernia repair, and that the risks of the mesh’s design outweigh any possible benefits.
Another mesh lawsuit was filed against device maker, Atrium, over its C-Qur Mesh. The plaintiff alleged that Atrium was negligent and hid the dangers of its C-Qur mesh. In late 2013, he underwent a surgical hernia repair with Atrium’s C-Qur and in 2016 underwent revision surgery to have the mesh removed after suffering abdominal pain. A pathology report revealed that a “foreign body giant cell reaction” took place in his body that included scarring of the tissue surrounding the mesh implant. The man and his wife also alleged that Atrium negligently designed and fraudulently convinced physicians that the C-Qur mesh product was safe when the device maker allegedly knew that the polypropylene surgical netting was biologically incompatible with human tissue and this defect increased risks for significant medical complications, according to Law360. Allegations also include that Atrium neglected to properly review and reveal adverse event reports to the FDA and to put in place appropriate tracking and evaluation procedures over injury complaints. Atrium also allegedly “stealth recalled” the C-Qur mesh and other mesh products on various occasions by stopping production with no notification to physicians, federal regulators, or patients. This case was filed in the U.S. District Court for the District of New Hampshire.
A number of surgeons and hospitals have ceased using the C-QUR mesh due to increasing reports of infection rates, bowel obstructions, and allergic reactions to the fish oil coating on the C-QUR. The C-QUR is very difficult to remove once it attaches to the bowel.
Filing a Hernia Mesh Lawsuit
If you or someone you know suffered injuries related to the use of hernia mesh implants, you may have valuable legal rights. Our hernia mesh lawyers offer free, no-obligation case evaluations. For more information, please call 1-800-YOURLAWYER (1-800-968-7529).