Chronic Pain, Hernia Recurrence & Adhesions
Several recent product liability lawsuits back up these unpublished conclusions. In a series of federal lawsuits, four Physiomesh patients say they began to suffer from severe side effects soon after receiving the mesh in laparascopic hernia procedures.
One patient claims to have experienced three hernia recurrences, despite the intended purpose of Physiomesh being to prevent hernia recurrence. Another man says that his Physiomesh implant became a “breeding ground” for bacteria, leaving his intestines riddled by fistula and abscesses. All four patients were forced to undergo re-operation. Court documents show that surgeons invariably discovered severe adhesions, with portions of the hernia mesh attached to internal organs.
Inside the body, surgical meshes can “erode,” disintegrating over time and releasing shards of synthetic material. When the fragments of a mesh begin to migrate, they can threaten internal organs and body tissues, leading to pain, diminished organ function and even death. With these allegations in hand, it’s no surprise that Physiomesh implants intended for laparoscopic hernia repairs have been pulled from the market.
Has Physiomesh Surgical Hernia Mesh Been Recalled?
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.”
“Recall” In Europe, “Withdrawal” In US
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’s History With Mesh Troubles Patients
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.
Transvaginal Mesh Withdrawal
On June 4, 2012, Ethicon announced that four versions of transvaginal mesh would be withdrawn from the market:
- Gynecare TVT Secur System
- Gynecare Prosima Pelvic Floor Repair System
- Gynecare Prolift Pelvic Floor Repair System
- Gynecare Prolift+M Pelvic Floor Repair System
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.
What Is A “Market Withdrawal”?
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.
- Class I Recall – reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
- Class II Recall – use of or exposure to a violative product may cause temporary or medically-reversible adverse health consequences or where the probability of serious adverse health consequences is remote
- Class III Recall – use of or exposure to a violative product is not likely to cause adverse health consequences
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.
More On The Risks Of Hernia Mesh