Many hernia mesh implant have lead to serious complications. Some of them have been put on the market before the product was thoroughly tested.
Even though the Food and Drug Administration must give medical device manufacturer’s approval before they can put their products on the market, they don’t always go through rigorous testing. The FDA allowed hernia mesh manufacturers to put their products on the market using the 510(k) clearance process, which is a fast-track program. Unfortunately, this process allowed defective hernia mesh products onto to the market, which led to complications in many patients which led to Hernia Mesh lawsuits.
On this page we explain everything from complications to which companies are under fire to trial dates for lawsuits in 2017 and beyond. This all leads to the question you might be asking yourself when you have been injured and found this article: Do I qualify for compensation?
Hernias occur when there is weakness in the stomach wall which allows tissue or part of the intestine to poke through the weak area. Along with abdominal or umbilical hernias, there are many other types which surgeons can repair by either stitching them to enclose the bowel or tissue or they can use mesh to cover the hole and strengthen the area where the weakness was located.
Hernia mesh implants can be used on these types of hernias:
Inguinal hernias are the most common type of hernias and incisional hernias are the second most common type. Unfortunately, due to fast-tracking hernia mesh products, many of them have failed due to design defects, leading to serious complications.
There have been many complications reported by patients who’ve had hernia mesh applied during a hernia repair. Some of the more common complications linked to hernia mesh implants are:
Many hernia complications are the result of surgeons implanting the mesh after a laparoscopic hernia repair surgery. The laparoscopic procedure increases the risk of the hernia mesh touching other organs, which could cause them to adhere to those organs and cause multiple complications. Some of the manufacturers have taken their hernia mesh implants off the market, including Ethicon, who made the Physiomesh hernia mesh implant.
Ethicon, the manufacturer of Physiomesh, recalled the product in May of 2016 after the implant was linked to several hernia recurrences and revision surgeries. Along with recalls in the United States, Johnson and Johnson, Ethicon’s parent company, Physiomesh was also been recalled in Europe and Australia due to complications.
Like most hernia mesh implants, Physiomesh is made from polypropylene, which has also been used to make bladder slings and transvaginal mesh, both of which had resulted in thousands of lawsuits. The only difference in the hernia mesh is the company used an absorbable on each side of the polypropylene material. This product used the FDA’s 501(k) fast-track clearance procedure to get their product on the market.
There have been several lawsuits filed involving the mesh product, including a suit filed in September 2016 by a Florida woman, Joann Quinn. The lawsuit alleges the mesh used on her caused bowel and abdominal adhesions and she had to undergo surgery to remove them. However, the doctor reported he couldn’t remove all the adhesions and Ms. Quinn could suffer from pain and further complications for the rest of her life.
The first trial against Ethicon and their Physiomesh product has been set for 2018. The lawsuit brought by a patient, Matthew Huff, alleges the product caused him to have multiple complications after it was implanted during his 2013 hernia surgery. It was the first lawsuit filed against Physiomesh and it alleges when Huff went to the hospital complaining of chills, fever, nausea and severe pain, doctors found an infection had developed around the implant.
The infection had caused several abscesses and a fistula to develop, for which he needed surgery. A trial for the lawsuit was originally set for July 31, 2017, but both sides wanted more time to prepare due to the complexities of the issues involved in the case. Subsequent to Huff’s lawsuit, several others have been filed against Ethicon alleging complications due to their product’s design.
Another company, Atrium Medical Corporation, is also facing multiple lawsuits involving their hernia mesh product called C-Qur. The product was approved by the FDA in 2005 after it had also used the fast-track procedure 501(k). Many of the lawsuits allege Atrium’s hernia mesh product caused allergic reactions because the polypropylene material is coated with fish oil.
Allergic reactions are not the only issues with this product as there have been other complaints regarding it adhering to bowels, which caused them to twist or causing the bowel to become perforated. Some lawsuits also said the fish oil coating peeled off, causing the adherence of the mesh against the bowel and other tissues. The FDA had sent Atrium a warning letter regarding their inadequate reactions to complaints about the C-Qur product causing infections.
Along with the complications alleged in dozens of lawsuits, there were also 35 complaints about human hair being found in the sterilized products, which prompted the FDA to issue a permanent injunction in 2015 to stop Atrium from manufacturing the C-Qur device. However, before the injunction went into effect, several patients had already undergone surgery and had the hernia mesh implanted.
With dozens of lawsuits pending against Atrium Medical regarding the C-Qur hernia mesh implant, the lawsuits have been consolidated by the US Judicial Panel on Multidistrict Litigation. The US District court in New Hampshire is slated to preside over nearly two dozen of the lawsuits against Atrium. Most of these suits allege Atrium knew about their product’s design flaws which lead to inflammatory reactions to the product and resulted in improper implantation, bowel adhesions and other complications.
Multidistrict litigation simply speeds the process of hearing multiple lawsuits based on the same complaint or questions. So far, no class action lawsuits have been filed involving hernia mesh implants and these are the first suits to be lumped together in court. Along with Atrium Medical and Ethicon, there are other manufacturers facing suits regarding their hernia mesh implants as well.
One of the first hernia mesh implants to be recalled was C.R. Bard’s Kugel hernia mesh patches. It was approved in the 1990s and it was implanted over a million times. Unlike other hernia mesh implants, it contained a ring which would break after implantation and cause bowel and other organ perforations.
However, it was also made from polypropylene, which caused its share of complications as well. The ring was implanted in the mesh, which once implanted started to break down and, as it did, it began to shrink. The polypropylene would shrink smaller than the size of the ring, exposing it and causing it to buckle or break and perforate bowels or other organs.
Davol, which is a subsidiary of Bard, recalled the Kugel hernia mesh implants in 2005, 2006 and 2007. However, there are still lawsuits pending against the hernia mesh product, including a lawsuit in Rhode Island filed against Davol by a man, Wayne Smith, who had it implanted in 2005, prior to it being recalled. Shortly after his surgery, he began to complain of abdominal pain and tenderness around the surgical site and it was recommended he have the implant removed.
C.R. Bard and Davol attempted to have the lawsuit dismissed, citing the plaintiff’s claims didn’t satisfy the laws of Rhode Island. However, the judge presiding over the case refused to allow it to be dismissed and the lawsuit against the manufacturer is being allowed to go forward. Since the ruling was made on November 28, 2016, the trial for a Hernia Mesh lawsuit may be scheduled soon in 2017.
The CR Bard corporation manufactures several other hernia mesh implants which have been named in lawsuits because of complications due to their design defects. Along with Davol’s Kugel hernia mesh, they have also been sued over PerFix Plug mesh implant and the 3DMax mesh implant. Both of these products have resulted in problems in the testicular area for men, causing pain or, in the PerFix Plug’s case, some testicles had to be removed.
Bard also owns the Ventralex ST hernia mesh implant, which has also been named in lawsuits. It was closely modeled after the Kugel mesh design, even though the Kugel mesh was recalled a decade ago. So far, the Ventralex implants have not been recalled, but there have been complaints filed against them alleging severe inflammatory reactions to the product.[/one_third]
With dozens of hernia mesh lawsuits pending, it is possible class action lawsuits could be filed, but so far none have yet been scheduled.
Only one trial date has been set so far for 2018, but more trials could be set soon.