Have you suffered injuries after undergoing a ventral hernia repair procedure? Here, the medical device liability attorneys at The Law Offices of Peter Angelos provide information regarding complications associated with the use of Ethicon Physiomesh for hernia repair procedures.
Each year, more than 100,000 ventral hernia repair surgeries are performed throughout the United States. During these procedures, surgeons often use hernia mesh, such as Ethicon Physiomesh, to support and strengthen the abdominal wall in effort to prevent hernia reoccurrence. However, reports suggest that Ethicon Physiomesh can cause several serious complications and that the product is less effective at preventing hernia reoccurrence than other similar products on the market.
What is Ethicon Physiomesh?
Ethicon—a subsidiary of Johnson & Johnson—obtained 510(k) premarket approval for its Physiomesh by the Food and Drug Administration (FDA) in 2010. This type of premarket clearance allowed the manufacturer to begin selling, distributing and marketing the Physiomesh without performing preliminary safety studies because the FDA found the product was similar in nature to other hernia mesh products that already existed in the market.
Physiomesh is a patch made from flexible polypropylene fibers. The product is used during laparoscopic ventral hernia repairs to reinforce the abdominal wall after hernia repair. Physiomesh also consists of absorbable Monocryl laminate intended to prevent inflammation and adhesion—a material also used in the design of Johnson & Johnson’s transvaginal mesh product.
Why was Physiomesh Withdrawn from the Market?
In May 2016, Johnson & Johnson issued a global market withdrawal for Ethicon Physiomesh after two studies found higher rates of hernia reoccurrence and necessary revision surgery compared to other hernia mesh products on the market. The studies suggested that the product posed safety risks to patients due to the possible need for re-operation.
Physiomesh Complications and Lawsuits
Patients who have undergone ventral hernia repair using Ethicon Physiomesh claim to have experienced several severe side effects including:
- Chronic pain
- Hernia recurrence
- Intestinal blockage
Specifically, a claim filed in December 2016 alleges that a patient was forced to undergo multiple mesh removal and revision surgeries after the Physiomesh adhered to vital organs in the patient’s body and the patient’s hernia reoccurred. The lawsuit alleges that the Ethicon product contains defects in its design and is unreasonably dangerous for use in hernia repair surgeries.
What Can You Do if You Have Been Injured by Physiomesh?
If you or a loved one has suffered pain or injury after undergoing ventral hernia repair that may have used Ethicon Physiomesh, it is important that you contact your physician to undergo a medical examination. If you have undergone additional surgeries due to hernia reoccurrence or mesh removal, you may be able to pursue damages for your suffering.
The Law Offices of Peter Angelos is currently reviewing claims regarding injuries and additional surgeries caused by Ethicon Physiomesh. Contact our medical device liability attorneys for additional information or to schedule a free consultation of your claim.