Mesh patches are now commonly used to repair hernias; when an organ, intestine or fatty tissue squeezes through a hole or weak spot in the surrounding muscle or connective tissue. Hernias occur most often at the abdominal wall. In some cases, hernias are visible as an external bulge, particularly when straining or bearing down. The only way to permanently fix a hernia is with surgery. According to the U.S. Food & Drug administration, more than one million hernia repairs are performed each year in the U.S. The problem is that hernias often return (“recurrence”) and require additional surgery. To reduce the risk of “recurrence”, hernia mesh patches are stitched inside the body to reinforce the weak tissues. It is estimated that hernia mesh patches are used in over 50% of hernia surgeries performed today.
The Ethicon Composite “Physiomesh” Hernia Patch, originally approved by the U.S. Food & Drug Administration in April of 2010, is a flexible, non-absorbable polypropylene (plastic) medical device made up of filaments that are knitted into a fabric and laminated. Like most hernia mesh patches, the FDA approved Ethicon’s “Physiomesh” hernia patch without requiring any thorough, rigorous clinical trials. The Ethicon “Physiomesh” hernia patch has a thick coating on both sides, intended to prevent the bowel from being exposes to the polypropylene. This is because polypropylene will essentially adhere to any tissue in the human body which it comes into contact with. Thus, the Ethicon Flexible “Physiomesh” heria patch is a very dangerous medical device because, the polypropylene can “stick” to the bowel and cause severe injuries. What’s worse, if no polypropylene is exposed the “Physiomesh” will not properly incorporate into the abdominal wall and instead will migrate (move around) within the patients abdominal cavity.
On May 25, 2016, Ethicon (a subsidiary of Johnson & Johnson) distributed an Urgent Field Safety Notice and Product Recall. In the “field safety notice”, Ethicon instructed doctors to no longer use their “Physiomesh” patches for hernia repair. In fact, Ethicon stated that complications associated with their “Physiomesh” patch were possibly related to specific characteristics of the “Physiomesh”, and admitted they were unable to instruct physicians on how to prevent hernia recurrences and complications associated with the product. Medical studies currently underway are investigating the rates of hernia recurrence and additional surgeries following “Physiomesh” patch implantation. It is likely that these studies have found high rates of complications associated with the “Physiomesh” patch, otherwise Ethicon would certainly not have withdrawn the product from the market.
In a 5-year study involving 3,242 patients in Denmark who had an incisional hernia surgery, 4-6% of mesh repairs resulted in a serious complication, compared to less than 1% of non-mesh repairs. The study, published in JAMA in October of 2016, warned:
“Mesh implantation prevented the need for subsequent re-operation in relatively few patients, suggesting that the benefits associated with the use of mesh are partially offset by long-term complications associated with its use.”
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Symptoms of Hernia Mesh Problems
- Abdominal Pain
- Chronic Infections
- Mesh Erosion
- Mesh Migration
- Mesh Folding
- Mesh Failure
- Hernia Recurrence
- Need for Revision Surgery
- Adhesions (scar-like tissue that sticks organs together)
- Bowel Perforation
- Bowel Adhesion
- Bowel Obstruction
- Organ Perforation
- Seromas (fluid buildup under the skin)
- Nerve damage
- Impotence or Urinary Problems in Men
If you or a loved one have had hernia surgery in which an Ethicon Composite “Physiomesh” Hernia Patch was implanted and suffered complications, or required revision/”recurrence” surgery, or are in need of surgery, contact us online or call us at 1-866-252-3535.
Physiomesh was compared to two other composite hernia mesh products. The Physiomesh resulted in the development of more seromas and less tissue integration than the other studied hernia mesh products.
A study comparing various techniques utilized to close a hernia defect with Physiomesh. Many patients experienced hernia recurrence regardless of the technique utilized.
25 patients implanted with Physiomesh were compared to 25 patients implanted with Ventralight. Within 6 months of hernia mesh implantation, 20% of those implanted with Physiomesh had experienced a hernia recurrence. None of those implanted with Ventralight experienced a hernia recurrence.
Physiomesh was compared to two other new hernia mesh products. Physiomesh demonstrated significantly lower incorporation strengths than the other hernia mesh products. Fractioning of the the Physiomesh coating was also observed over time, which lead to scar plate formation, but little to no abdominal wall adherence.
The mechanical properties 13 hernia mesh products were evaluated, including Physiomesh. Significant differences were observed depending on which mesh was implanted and how it was secured. The authors noted that hernia mesh materials are currently utilized as if they are uniform and interchangeable, when that is simply not the case. Additional instructions and training from Ethicon could have resulted more successful hernia repairs.
5 animals were implanted with Physiomesh and 5 animals were implanted with Ventralight. Animals implanted with Physiomesh exhibited significantly more inflammation, fibrosis, and hemorrhage.