Physiomesh hernia repair products have been linked to severe side effects. Nearly 100 patients have already filed suit:
While these medical devices have been withdrawn from the market, injured patients may be able to pursue significant financial compensation. Our experienced Hernia Mesh Attorneys can help.
Johnson & Johnson subsidiary Ethicon has issued a voluntary global “market withdrawal” for certain versions of Physiomesh, a surgical mesh product used to repair ventral hernia.
At least 80 patients have filed Physiomesh lawsuits, accusing medical device giant Ethicon of designing, manufacturing and selling a hernia repair patch that leaves patients at risk for severe injuries. While only a handful of these hernia mesh lawsuits have been filed at this time, attorneys believe that thousands of other hernia patients may also be eligible to pursue financial compensation.
In an Urgent Safety Field Notice published on May 25, 2016, Ethicon warned practicing physicians around the world to stop using Physiomesh Flexible Composite Mesh products immediately.
After reviewing unpublished data from two large hernia registries, medical device safety analysts had discovered that patients with Physiomesh Composite Mesh products were more likely to experience a hernia re-occurrence than patients with other mesh products. Physiomesh patients were also more likely to require additional operations.
The recall, communicated to both the US Food & Drug Administration and European regulatory authorities, includes only Ethicon’s Physiomesh Composite Mesh product line. Other products branded as Physiomesh, including the Physiomesh Open Flexible Composite Mesh Device, have not been withdrawn from the market.
Reviews of unpublished safety data from two European hernia registries (Germany’s Herniamed and the Danish Hernia Database) revealed that the Physiomesh Flexible Composite Mesh was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.
Ethicon believes that the problem is “multifactorial,” but has been unable to identify the exact cause of Physiomesh failures. In its urgent notice to physicians, the company suggests that a combination of product design issues, operative characteristics and patient factors may be at work.
Without an adequate understanding of the problem, Ethicon had no choice but to remove Physiomesh Composite Mesh products from the global market entirely.
While Ethicon may not have a clear picture of why Physiomesh products lead to more hernia re-openings and surgeries than other meshes, several patients have proposed their own theory.
In a series of Physiomesh lawsuits, hernia patients say the mesh product was defectively-designed. After experiencing severe side effects and undergoing multiple corrective procedures, these patients have decided to fight back, pursuing Ethicon and its parent company Johnson & Johnson in court.
The Physiomesh litigation is growing at a rapid pace. In fact, hernia mesh lawsuits have been filed so quickly that a panel of federal judges, the US Judicial Panel on Multi-District Litigation, has decided to “consolidate” similar claims, sending all federally-filed product liability lawsuits to the US District Court for the Northern District of Georgia.
In Atlanta, plaintiffs’ attorneys from across the country will band together to represent the best interests of their clients. As of September 12, 2017, over 80 Physiomesh lawsuits are currently pending in Georgia, where the actions will advance through pre-trial proceedings as a group.
Ethicon’s Physiomesh product is made from flexible fibers of polypropylene, a plastic, which are woven together into a patch. This isn’t rare; most mesh products feature a woven structure using some sort of synthetic filament. What distinguishes Physiomesh from other mesh devices is that the product’s mesh patch is coated in four other layers of synthetic polymer:
This multi-layer design, unique to Physiomesh, was marketed by Ethicon as an unparalleled way to reduce the risk of adhesion and inflammation, two major problems with other mesh products. In marketing materials, Ethicon was adamant that the multi-layer design made it far easier for Physiomesh products to be absorbed by a patient’s body after placement.
Plaintiffs say that all of those marketing promises were a lie. In recent Physiomesh lawsuits, attorneys representing injured patients argue that Ethicon’s multi-layer coating actually prevented the mesh from being absorbed, leading to intense inflammatory responses. Like an implant being rejected by its host, injured hernia patients say that their body’s reacted in severe and debilitating ways to the Physiomesh product, leading to widespread tissue damage and fistula formation.
Their allegations go even deeper, noting four potential product defects that could make Physiomesh unreasonably dangerous:
Niether Johnson & Johnson nor Ethicon have answered these damning allegations publicly. It is notable, however, that both companies already face thousands of product liability lawsuits over their transvaginal mesh and bladder sling products, both of which are made out of the same polypropylene material as Physiomesh.
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.
Patients accuse Ethicon of marketing Physiomesh as “safe and effective.” In reality, lawsuits contend that the mesh creates “an unreasonable risk of severe adverse reactions,” including:
Plaintiffs claim that many, if not all, of these severe potential complications should have been predicted long before Physiomesh hit the market. In fact, many patients believe that Ethicon failed to warn the public of the product’s risks, downplaying both the severity and duration of likely side effects.
A ventral (“abdominal”) hernia begins when tissues or portions of intestine begin to bulge outward, often through weakened or thinning areas of the abdominal wall muscles. Marked by sensations of pain and pressure, ventral hernia are usually characterized by a visible bulge on the abdomen, which becomes more pronounced while straining or experiencing a coughing fit.
Doctors define three basic types of ventral hernia:
Ventral hernia are extremely common, according to the University of California at San Francisco. As many as 30% of patients who undergo abdominal surgery will eventually develop a hernia, usually because their incision fails to heal properly.
Despite their frequent occurrence, surgery is really the only way to repair a ventral hernia. Between 350,000 and 500,000 ventral hernia repairs are performed every year in the United States alone, the Society of American Gastrointestinal and Endoscopic Surgeons reports.
In past decades, most patients would undergo “open” hernia repairs, in which their abdomens were opened surgically and a mesh or suture was applied to close the gap in the abdominal muscles. These open surgeries are still required in cases when major abdominal construction is necessary.
Today, doctors have moved toward less-invasive procedure types, including the laparoscopic surgeries in which Ethicon’s recalled Physiomesh products were used. In laparoscopic procedures, only small incisions are required. Instead of opening the patient’s abdomen entirely, physicians are able to place a patch or mesh using thin medical instruments and cameras. This method often promises shorter recover times and fewer side effects than a major surgical procedure.
In the American media, Ethicon’s decision has been branded as a “market withdrawal,” not a recall. Internationally, the situation appears different.
Switzerland’s FDA-equivalent, the Swiss Agency for Therapeutic Products, published an “Urgent Field Safety Notice” that characterized the withdrawal of Physiomesh as a “voluntary product recall.” The notice, dated May 25, 2016, was drafted and distributed by Ethicon. Featuring 34 references to the word “recall,” including clear statements like “Ethicon is recalling the product,” the warning never mentioned the word “withdrawal” once. It was also published by health regulators for the Netherlands and Germany, where the nation’s Federal Institute for Drugs and Medical Devices clearly labeled their report on the issue, “Recall of PHYSIOMESH flexible composite mesh, Ethicon.”
Likewise, Britain’s National Health Service has written of Ethicon’s move as a “precautionary recall.” Through its national Department of Health, the Australian government has also labeled the “withdrawal” of Physiomesh Flexible Composite Mesh devices as a “recall.”
The issue appears to have been treated in a substantially different way for US patients and healthcare professionals. Oddly, the US Food & Drug Administration has never published any warning or withdrawal notice involving Physiomesh products. The media, for that matter, has reported widely on Ethicon’s “market withdrawal,” but without fail, US reporters cite European recall notices as evidence. The National Institutes of Health currently lists an Ethicon Physiomesh product with the model number PHY2025V as “in commercial distribution.” This same model of Physiomesh is clearly included in the company’s international recalls.
Ethicon is a subsidiary of Johnson & Johnson, purchased by the global healthcare giant in 1949 to expand the company’s surgical product line. While Ethicon has been designing and manufacturing surgical sutures since 1887, the company’s work has only come to public attention over recent decades, after a series of notable recalls and “market withdrawals” involving surgical mesh products.
Thus far, Ethicon has stopped short of recalling previously-sold mesh products, despite thousands of adverse event reports in which patients blame their mesh implantations for severe complications.
On June 4, 2012, Ethicon announced that four versions of transvaginal mesh would be withdrawn from the market:
The products, used to strengthen the pelvic floor muscles of women with pelvic organ prolapse, were associated with extremely high complication rates. Chronic pain, severe infections and abnormal bleeding were common, as the mesh eroded through the vaginal wall. Thousands of women filed suit, accusing Ethicon and other pelvic mesh manufacturers of convincing surgeons to use an unproven product with significant risks. In the wake of these lawsuit filings, Ethicon chose to remove Prolift transvaginal meshes from the market. The FDA, however, chose not to issue a full recall.
Like the company’s Physiomesh, designed for hernia repair, Prolift transvaginal meshes had gained FDA approval using the 510(k) clearance pathway, which allows a medical device to be sold without formal FDA approval if it is “substantially equivalent” to a previously-approved product.
The difference between a “market withdrawal” and a full recall is one of degree. Most recalls involve some form of government action, normally undertaken by the US Food & Drug Administration.
Even so-called “voluntary” recalls, in which a manufacturer makes the pro-active choice to remove a product from the market, are usually negotiated by the government. As ConsumerReports writes, “voluntary” in this context is really a misnomer. Instead of being truly optional, voluntary recalls are “government-speak for a deal that a manufacturer or retailer of a hazardous product has negotiated with the federal agency in charge of overseeing the safety of that product category.” In fact, government agencies rarely force manufacturers to recall their products. That includes medical devices that come under the Food & Drug Administration’s authority.
Market withdrawals, on the other hand, are voluntary by definition, according to the FDA. When companies pull a product through this route, it almost always implies that the product is affected by a “minor violation,” but one that would not be subject to a federal agency’s legal action.
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.
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.
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.
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.
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.
Read The Complaint: Huff v. Ethicon
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.
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.
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.
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.
US Judicial Panel on Multidistrict Litigation: Statistics Report: Pending MDL Dockets (page 2)