Johnson & Johnson’s Ethicon unit has recalled its blockbuster hernia repair mesh medical device from the market worldwide, after it was found to cause severe side effects and surgical revisions. According to Johnson & Johnson the exact mechanism for the failures are unknown, and the company conveniently blamed patient factors and implanting doctors for the complications.
The Ethicon Physiomesh recall was announced recently in an Urgent Field Safety Notice sent to doctors and hospitals worldwide.
The FDA has classified the action as a “Market Withdrawal”, and Johnson & Johnson is requiring doctors and hospitals to return unexpired products for a refund.
What is Ethicon Physiomesh?
Ethicon uses plastic or polypropylene to make the base layer of the Physiomesh. The Physiomesh is used for laparoscopic ventral (abdominal) and inguinal (groin) hernia repair.
Polypropylene is the same material that Ethicon used to make their transvaginal mesh and bladder slings. Ethicon is exposed to thousands of lawsuits over its polypropylene transvaginal mesh and bladder slings. Ethicon added an absorbable film coating to each side of the polypropylene to create the Physiomesh. The coating on each side of the Physiomesh is composed of slightly different compounds.
German and Danish Medical Registries found the problem
The Ethicon Physiomesh Flexible Composite Mesh stealth recall was issued after an analysis of data found that the products have higher than average recurrence and re-operation rates following laparoscopic ventral hernia repair. The data came from the Herniamed German Registry and the Danish Hernia Database.
Unfortunately here in the U.S. we do not have a nationwide registry of side effects or failures associated with our medical products. And when patients or doctors complain or raise an issue with a product, they tend to get swept under the rug and the big medical device makers deny any problems until it is too big to contain or it may come to light from whistle blower action.
According to the Urgent Field Notice, “Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.
Consequently, Ethicon have not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and have decided to recall ETHICON PHYSIOMESH Composite Mesh from the global market.”
Recalled Ethicon Physiomesh Lots
The action affects the Ethicon Physiomesh Composite Mesh product line. The product codes affected include PHY0715R, PHY1015V, PHY1515Q, PHY1520R, PHY1520V, PHY2025V, PHY2030R, PHY2535V, PHY3035R, and PHY3050R.
The recall does not affect the Ethicon Physiomesh Open Flexible Composite Mesh device or other Ethicon mesh products.
Ethicon Physiomesh Lawsuits
Patients and surgeons have been complaining about the complications and the need for re-do surgery when the abdominal or inguinal hernia recurred.
The Physiomesh device was a big hit for Johnson & Johnson. Before the Physiomesh recall, Ethicon developed the Physiomesh Open. Ethicon submitted a 510(k) application for the Physiomesh Open in June, 2014, and received clearance in October, 2014.
Ethicon gave the Physiomesh Open about half a year to gain market traction before they finally decided to “voluntarily withdraw” the regular Physiomesh from the market.
Several Physiomesh lawsuits have been filed against Ethicon and Johnson & Johnson, with the first one slated to go to trial in January 2018. Ethicon has been battling lawsuits for years against its transvaginal mesh products, which are also made from polypropylene.
According to the lawsuits, the Physiomesh products were defectively designed and manufactured, using plastic materials that react to human tissues, causes infections and can migrate to other parts of the body. The lawsuits also indicates that the plastic mesh can cut tissues and fails to actually perform as intended leading to recurrence of the hernias.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.