Reviews of unpublished safety data from two European hernia registries (Germany’s Herniamed and the Danish Hernia Database) revealed that the Physiomesh Flexible Composite Mesh was associated with an increased risk of hernia recurrence and re-operation.
In response, Ethicon instructed surgeons around the globe to stop using its Physiomesh Flexible Composite Mesh in laparoscopic hernia repair procedures. But the company has yet to explain the cause behind these adverse events, blaming the problem on multiple potential factors, including “possible product characteristics” and “operative and patient” attributes. In fact, Ethicon has never made these studies, which were commissioned by the company, available to the public.
Mesh Presents “Unreasonable Risk,” Plaintiffs Say
In their product liability lawsuits, former Physiomesh patients say the mesh product is marred by “numerous defects,” creating an unreasonable risk of severe injuries and side effects.
Huff v. Ethicon
Matthew Huff, a resident of Illinois, says he underwent a Physiomesh repair to treat an abdominal hernia in 2013. Nearly two years later, Huff began to experience severe abdominal pain, along with obvious signs of infection, including fever, nausea, chills and red abdominal rashes.
After he was hospitalized, doctors found that Huff was indeed suffering from an infection, which had begun to grow “in and around” his abdominal mesh. The infection had caused two abscesses and eaten away at Huff’s intestines, creating a fistula. Huff was treated successfully, but says he continues to live with “two open abdominal wounds[,]” remnants of a procedure intended to remove damaged tissue from his belly. The wounds need to be “cleaned and packed daily,” Huff writes in his complaint.
Matthew Huff’s lawsuit was filed on April 1, 2016 in the US District Court for the Southern District of Illinois. The case has been logged as number 3:16-cv-00368-JPG-PMF.
Quinn v. Ethicon
On May 30, 2014, Florida resident Joanne Quinn underwent a laparoscopic procedure to repair incisional hernias, which had opened at the site of a prior surgery. Her surgeon used a Physiomesh patch to close the hernias, but Quinn’s condition did not improve after the procedure. In fact, it worsened, she says. Quinn was left with “persistent abdominal pain, diminished bowel motility and bowel obstruction,” symptoms she lived with for more than a year.
In July of 2015, Quinn underwent an exploratory laparotomy, in which her surgeon, Dr. George Nassif, opened her abdomen. Inside, Nassif found “severe adhesions,” where the Physiomesh hernia patch had attached itself to Quinn’s bowels and abdominal wall. The surgeon spent two hours removing fragments of the mesh product from Quinn’s internal organs, but was “unable to remove all of the offending material,” court documents relate.
Quinn’s hernia mesh lawsuit was filed on September 22, 2016 in the US District Court for the Middle District of Florida. Her case has been registered as number 6:16-cv-01663-PGB-DAB.
Watring v. Ethicon
David Watring, a resident of Massachusetts, received a Physiomesh patch to repair his parastomal hernia on April 11, 2013. The procedure did little to solve Watring’s health issues, however.
Only seven months later, the man found himself back in the hospital, being treated now for a recurrence of his hernia. As his complaint states, portions of small intestine were beginning to bulge through Watring’s stoma. Even after this second procedure, Watring’s problems were not over. On March 30, 2016, more than three years after he first received the Physiomesh implant, Watring again presented to a Massachusetts hospital suffering from a symptomatic recurrence of his hernia.
His condition, however, had worsened significantly. Inside the hernia, surgeons discovered “several loops of small bowel,” according to his complaint. These loops of intestine had begun to develop “dense adhesions,” clinging together and preventing proper intestinal function. Watring’s doctors worked for hours, removing the adhesions, but soon, the man developed “yet another” hernia, court documents say. Watring is currently consulting with his doctor to see if more surgeries are feasible.
Watring’s lawsuit was filed on November 12, 2016 in the US District Court for Massachusetts. His claim has been logged as case number 1:16-cv-12278-RGS.
Gilman v. Ethicon
Sarah Gilman, a resident of Florida, underwent laparascopic surgery on February 3, 2016 to repair a ventral hernia. Not long after her Physiomesh Composite mesh was placed, Gilman began to experience painful symptoms. She returned to the hospital in August and soon underwent a revision surgery. During the procedure, Gilman’s physicians found that her hernia had recurred, leading to severe pain. Moreover, she had begun to develop adhesions.
Gilman’s case was filed on December 27, 2016 in the US District Court for the Middle District of Florida, Tampa Division. Her hernia mesh lawsuit has been logged as case number 8:16-cv-03502-JDW-JSS.
Hernia Mesh Blamed For Adhesions, Organ Damage
Ethicon is a wholly-owned subsidiary of Johnson & Johnson, one of the world’s largest healthcare conglomerates. Devoted to producing surgical products, Ethicon is a dominant force in the market for surgical meshes, a range of devices used to patch up pathological openings inside the body.
Mesh products were first designed to close a range of hernia-type medical conditions, in which internal tissues and organs begin to bulge out through weak points in the muscle wall. Meshes soon became indispensable to surgeons, allowing doctors to reinforce their sutures with a bioabsorbable patch that would then be assimilated by a patient’s body tissues.
Lawsuits Claim Design Hides “Numerous Defects”
Mesh repairs are now standard throughout the world, but the concept of using a woven patch to close hernias has actually been around for nearly 60 years. The idea’s first clinical implementation came in 1989, according to the Michigan Institute for Laparoscopic Surgery, and numerous innovations would follow. By 1998, laparoscopic hernia repairs using mesh products had become remarkably effective, leading to recurrence in only 0.4% of patients.
In 2010, Ethicon introduced an innovative new product, the Physiomesh Flexible Composite Mesh, which featured an unprecedented design. Like most abdominal mesh products, Physiomesh was based on a simple lattice-style patch made from plastic. Ethicon’s innovation was to “laminate” this basic patch in four separate layers of synthetic polymer.
With the mesh coated in layers of polymer, Ethicon assured surgeons that Physiomesh would be able to solve many of the problems associated with traditional mesh products. Physiomesh would reduce inflammation, and was distinguished by a lower risk of adhesion, a potential complication in which the mesh gets stuck to other internal organs. Moreover, the multi-layer design of Physiomesh meant that a patient’s body could more easily absorb the product, lowering the risk of infections.
Alleged Design Defects
This design, in which a mesh is coated by multiple layers of synthetic polymer, is wholly defective, according to plaintiffs. In fact, several patients say that Physiomesh was actually designed so ineffectively that, in practice, the mesh did the opposite of what it was designed to do.
Instead of being absorbed back into the body after implantation, Physiomesh features an “anti-adhesion barrier” that prevents reabsorption, one plaintiff writes. The mesh can fold, buckle or migrate inside the body, the patient says, posing a significant threat to other internal organs. As we’ve seen, several plaintiffs have already claimed that the Physiomesh product became adhered to other organs after implantation, leading to severe pain and decreased organ function. Some patients have been forced to undergo lengthy adhesiolysis procedures, in which surgeons attempt to separate elements of the mesh from adjacent body surfaces.
Where inflammation is concerned, the product’s plastic and polymer components are “biologically incompatible,” patients claim. Rather than reduce the risk of inflammation, plaintiffs argue that the design unique to Physiomesh actually increases the risk, leading to severe immune system responses. As one plaintiff writes, “the multi-layer coating provides a breeding ground for bacteria,” but prevents dangerous pathogens from being eliminated by the body’s natural immune responses.
Federal Panel Transfers Claims To Georgia Court
While only 80 Physiomesh lawsuits have been filed so far, many legal observers believe that thousands of similar lawsuits are on their way. In response to the growing number of complaints, the US Judicial Panel on Multi-District Litigation has granted requests to move the entire federal litigation to a court in Georgia. Now, lawsuits filed over revision surgeries allegedly caused by Physiomesh side effects will move through court proceedings in the US District Court for the Northern District of Georgia. It is likely, though not certain, that claims filed in the future will be transferred to the Atlanta federal court.
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