Ethicon, a division of Johnson & Johnson has announced it is removing a popular hernia repair product, Ethicon Physiomesh, from the market after it was found to cause severe side effects and surgical revisions. The company, while the FDA has officially classified the action as a “Market Withdrawal,” and Johnson & Johnson is requiring doctors and hospitals to return unexpired products for a refund. Ethicon has also issued a worldwide Urgent Field Safety Notice sent to operating room managers, materials management personnel and hospital surgical chiefs.
The Physiomesh withdrawal came after the in-depth analysis of unpublished data from two European medical registries. The data from Herniamed German Registry and Danish Hernia Database showed the rates of hernia recurrence and revision surgeries after a minimally invasive ventral hernia repair using Ethicon Physiomesh Composite Mesh were higher than the average rates for the comparative set of meshes among patients. Ethicon so far has only offered a vague statement that suggests they believe “possible product characteristics, operative and patient factors may have played a role.” This is a thinly veiled attempt to blame patient factors and implanting doctors for the complications and doesn’t really explain the high failure rates or why the company has chosen to remove one of its more profitable products from the market.
Physiomesh is not the first surgical mesh product that Ethicon has come under scrutiny for. The company is also facing problems with its transvaginal mesh products that treat stress urinary incontinence and pelvic organ prolapse in women. Over 30,000 transvaginal mesh lawsuits are currently pending that allege the devices cause complications including infection, organ perforation, chronic nerve damage, and chronic pain.
Physiomesh is used for laparoscopic ventral (abdominal) and inguinal (groin) hernia repair and is composed primarily of a polypropylene base layer. This is the same polypropylene material used in the base layer of their transvaginal mesh and bladder slings. However with Physiomesh, Ethicon added an absorbable film coating made of slightly different compounds to each side of the polypropylene to create the hernia patch. One of the studies stated that the Physiomesh design of having an absorbable barrier on both sides of mesh as opposed to normally one side might lead to failure of integration into tissues. Other complications have included, pain, infection, hernia recurrence, scar adhesion, intestinal blockage, bleeding, and perforation of neighboring tissues or organs.
There are already several Physiomesh lawsuits filed against Ethicon and Johnson & Johnson with the first scheduled for trial in January 2018. The lawsuits claim the Physiomesh products were defectively designed and manufactured, using plastic materials that react to human tissues, cause infections and can migrate to other parts of the body. The Physiomesh lawsuits also charge that the polypropylene based mesh can cut tissues and fails to actually perform as intended leading to recurrence of the hernias.
At Saunders & Walker we have long advocated for patients who were harmed due to dangerous and defective medical devices. If you or a loved one believe you have suffered pain or injuries after having Physiomesh implanted for hernias or from any transvaginal mesh product implanted to treat stress urinary incontinence and pelvic organ prolapse, please contact us for a free consultation and to learn more about your legal rights.