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.
Ethicon Issues Physiomesh Global Market Withdrawal
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After reviewing unpublished data from two large hernia registries, medical device safety analysts had discovered that patients with Physiomesh Composite Mesh products were more likely to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 Other products branded as Physiomesh, including the Physiomesh Open Flexible Composite Mesh Device, have not been withdrawn from the market.
What’s Wrong With Ethicon’s Hernia Mesh?
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.
Hernia Patients Sue Over Alleged Physiomesh Injuries
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 from Florida and Illinois 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.
How Does Physiomesh Work?
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:
- two layers of polydioxanone – a synthetic polymer used to manufacture surgical sutures
- two layers of Monocryl, a polymer trademarked by Ethicon
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.
Patients Say Multi-Layer Design Is Defective & Dangerous
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:
- Physiomesh’s multi-layer coating is impermeable to fluids. When attached to the body, the mesh prevents fluids from escaping, allowing for seroma formation. A seroma is a pocket of clear fluid that can build up inside the body after surgery. Among other serious complications, seroma formation can lead to infections and abscesses.
- The mesh’s multi-layer coating is a “breeding ground for bacteria,” allowing infections to spread.
- The multi-layer coating is toxic to living cells and harmful to organic tissues, preventing wounds from healing appropriately and exacerbating inflammation and immune system response.
- After Physiomesh’s outer coating has begun to degrade, the underlying plastic mesh becomes exposed to surrounding tissues and organs. The mesh can then become adhered to organs, leading to organ damage and increasing the likelihood of a fistula.
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.
Potential Physiomesh Complications Lead To Infection, Surgery
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:
- Chronic pain
- Hernia recurrence
- Abdominal bulge
- Adhesion to internal organs – an abnormal joining of membrane surfaces due to inflammation or injury
- Foreign body response
- Rejection of the implant
- Inadequate absorption of the mesh
- Device migration
- Scar formation
- Improper wound healing
- Excessive and chronic inflammation
- Erosion of the abdominal wall
- Granuloma – a type of disease-related inflammation involving collections of immune cells
- Seroma – pockets of clear fluid that can develop in the body after surgery
- Nerve damage
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.
What Is A Ventral Hernia?
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:
- Incisional ventral hernia – occurs at the site of a past incision, like after a surgery
- Epigastric ventral hernia – occurs above the navel
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.
Treating Hernia: Open & Laparoscopic Surgeries
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.
Further Reading On Mesh Risks