Have you recently gone through a surgery in which Ethicon’s Physiomesh or another physiomesh product was used and you suffered injuries? If so, we may be able to help. Our lawyers are currently investigating claims that Physiomesh and other mesh products have led to adverse events for patients. This hernia patch is made from filaments woven into fabric, from which point it is laminated between separate lawyers of Monocryl. The purpose of this mesh to serve as an anti-adhesive and anti-inflammatory.
These mesh products have been out since March, 2010, but they were approved on an FDA 510(k) application, meaning that since it was classified as similar to other products on the market, the manufacturer did not have to go through with comprehensive clinical trials. Research is still being conducted into the full implications of these mesh products and what their potential defects mean for patients who have Physiomesh.
The Ethicon physiomesh flexible composite surgical mesh has unfortunately been associated with adverse patient outcomes. Recent studies and reports from patients indicate that these have a much higher rate of hernia reoperation and recurrence. The parent company of Ethicon, Johnson & Johnson, withdrew their surgical mesh from the market in May of 2016 but unfortunately it may still be tied to a broad range of injuries. As a result, the company could be facing numerous lawsuits by the individuals who are harmed.
Many other mesh products have made headlines in recent years due to patient complications and pain. For example, Ethicon’s transvaginal mesh products that are designed to prevent pelvic organ prolapse and urinary incontinence in women have led to thousands of lawsuits by the patients who were negatively impacted.
The physiomesh products were taken off the market in May 2016 by Ethicon after an extremely high rate of hernia reoperation and recurrence was seen in patients who got the product. Two different registries were used to document hernia procedures. The withdrawal affected all lot numbers of the Ethicon physiomesh flexible composite and the announcement from the company to pull these products off the market was followed by safety announcement issued by the FDA.
The safety alert and the subsequent withdrawal instructed surgical facilities and physicians to take all physiomesh inventory from their practice and return them to the manufacturer. Unfortunately, many affected patients were already victims of the dangerous surgical mesh and many others may still be at serious risk. The physiomesh product is made of polypropylene, an artificial plastic that is intended to cut down on inflammation. In some patients however, this may have done the exact opposite. Some of the complications associated by the mesh’s failure to operate appropriately include:
- Obstruction of organs
- Bowel adhesions
- Reoperation requirement
- Mesh migration
- Abdominal swelling
- Hernia recurrence
- Bacterial infection
Ethicon Physiomesh Lawsuit
Numerous lawsuits were already filed by consumers who have suffered after having the Ethicon physiomesh given to them. The manufacturer, Ethicon, has come under fire as well as the parent company Johnson & Johnson. The Ethicon physiomesh flexible composite surgical mesh was first introduced in the United States in 2010 for use in abdominal surgeries, specifically for repair of hernias.
It is implanted laparoscopically. It was approved by the U.S. FDA under the 510(k) premarket authorization, which allows manufacturers to avoid clinical studies by arguing that the product they have developed is similar to products already on the market. Many of the products that are approved using this procedure have never been tested on human patients. Patients who receive hernia repair procedures often experience serious pain as well as lengthy recovery time. Another procedure can be even more serious for these patients.
Recurrence of an already-repaired hernia can be more difficult, put the patient at higher risk of infection, lead to serious complications and require longer in-operation time. Those patients who suffered complications after obtaining Ethicon physiomesh could be eligible to receive compensation in the event that the Ethicon physiomesh flexible composite was implanted between the dates of March 1, 2010 and May 31, 2016, implanted to treat an abdominal or ventral hernia, or implanted laparoscopically. Consulting with an experienced defective medical device attorney is strongly recommended if you find yourself in this situation.