Patients with a hernia who were implanted with a synthetic mesh device like Ethicon’s Physiomesh Flexible Composite Hernia Mesh to repair their hernia are suffering devastating injuries as a result of the mesh eroding through the wall of the intestine, causing an infection, obstructing the bowels, and other serious complications. If you underwent surgical repair of a hernia with mesh, and you have since suffered one or more severe side effects, contact a knowledgeable hernia mesh injury lawyer today to discuss your legal options. You may have grounds to file a hernia mesh lawsuit against the mesh manufacturing company, in order to pursue financial compensation for your injuries and medical expenses.
Long before hernia mesh was introduced to the market, surgeons repaired hernias using the shouldice technique, which originated at the Shouldice Hospital in Ontario, Canada, and is “internationally recognized as one of the safest and most effective techniques for repairing hernias.” The shouldice technique involves placing the fatty tissue and any part of the intestine that may have protruded through the abdominal wall back into position, and then reinforcing the damaged section of the abdomen by repairing each muscle layer individually. For more than 70 years, the Shouldice Hospital has maintained a success rate of 99.5% on primary inguinal hernia repairs using this technique.
In some cases, “watchful waiting” may also be a good option for individuals with hernias, especially in instances where the hernia isn’t extremely large or painful. In a 2012 Reuters article, researchers compared “short- and long-term outcomes in men with symptom-free hernias who were randomly assigned to get surgery right away or take a more conservation [watchful waiting] approach.” According to the article, “The main advantage of delaying is that you might permanently avoid this painful operation,” which can result in serious complications like infection and chronic pain.
April 2010 – The FDA approves Ethicon’s Physiomesh Flexible Composite Mesh through its 510(k) approval program, based on the device being “substantially equivalent” to Proceed Mesh, Ultrapro hernia system and Ultrapro Mesh, all of which are manufactured by Ethicon.
2011 – A study published in the Annals of Gastroenterology reports that, “Given the popularity of minimally invasive surgery utilizing polypropylene mesh for incisional hernia repair, related complications such as postoperative hematoma and seroma, foreign body reaction, organ injury, infection, mesh rejection, and fistula are being noted.”
April 2011 – An adverse event report is submitted to the FDA, claiming that a Physiomesh device pulled away from the abdominal wall, resulting in the need for a second surgery to remove the mesh.
June 2014 – Ethicon submits a modified version of its hernia mesh product, the Physiomesh Open Flexible Composite Mesh device, for 510(k) approval from the FDA.
October 2014 – The FDA approves Ethicon’s Physiomesh Open Flexible Composite Mesh Device, but notes that “the FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.”
October 2014 – The FDA issues a safety communication warning about “complications that may occur with the surgical mesh that is sometimes used to repair hernias,” including “adverse reactions to the mesh, adhesions (when the loops of the intestines adhere to each other or the mesh), and injuries to nearby organs, nerves or blood vessels.”
May 2016 – Ethicon withdraws its Physiomesh device from the market, indicating that “the recurrence/reoperation rates after laparoscopic ventral hernia repair using Ethicon Physiomesh Composite Mesh were higher than the average rates of the comparator set of meshes among patients in [two large independent hernia registries].”
August 2011 – In a study published in the journal Hernia, researchers note, “We have seen several patients with serious late complications of these [composite] meshes placed intraperitoneally. Some of these patients needed small bowel resection and mesh removal.”
August 2012 – The journal Surgical Infections publishes research indicating that polypropylene is “characterized by high tensile strength and vigorous tissue ingrowth, but is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”
October 2013 – A study published in JSLS: Journal of the Society of Laparoendoscopic Surgeons compares the outcomes of five animals implanted with Physiomesh and five implanted with Ventralight mesh. According to their findings, the Physiomesh animals experienced significantly higher rates of inflammation, hemorrhage and fibrosis.
October 2013 – Researchers discuss the complications associated with polypropylene mesh for laparoscopic hernia repair, and note that “even a composite mesh can have complications.”
May 2014 – Researchers compare 637 hernia mesh repairs and 1,145 suture repairs, reporting that hernia mesh repair is associated with a slightly lower rate of hernia recurrence, but a higher rate of severe complications, like seroma and surgical site infection.
October 2014 – The Journal of the Mechanical Behavior of Biomedical Materials publishes a report suggesting that hernia mesh products are often used as if they are uniform and interchangeable, which they are not. The researchers also note that, had Ethicon provided additional instructions and training for implanting surgeons, more successful hernia repairs could have been performed.
August 2015 – Research published in the journal Surgical Endoscopy associates Physiomesh with significantly lower incorporation strengths than the two other hernia mesh products studied. The researchers also observe fractioning of the Physiomesh coating over time, which led to “an increase in interfilamentary granuloma formation, leading to scar plate formation.”
August 2015 – Research published in the Journal of the American College of Surgeons indicates that, out of 768 patients who underwent hernia pair, 10% experienced a hernia mesh infection. The study also indicates that 33% of patients with a preoperative MRSA+ infection experienced a hernia mesh infection.
March 2016 – The journal Surgical Endoscopy publishes a study comparing the outcomes of 25 patients implanted with Physiomesh and 25 patients implanted with Ventralight hernia mesh. Within six months of implantation, 20% of patients implanted with Physiomesh suffered a hernia recurrence, compared to 0% of those implanted with Ventralight mesh.
April 2016 – The FDA releases an article on hernia surgical mesh implants, indicating that “many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market.”
May 2016 – A review of unpublished data from a pair of European registries in Germany and Denmark shows higher revision rates with Physiomesh flexible composite mesh, compared to other meshes used for laparoscopic ventral hernia repair.
August 2016 – A study published in the medical journal Hernia reports that Ethicon’s Physiomesh device is associated with the development of more seromas and less tissue integration that other hernia mesh products.
August 2016 – Researchers follow 632 patients for two years after being implanted with hernia mesh, and report that 31% experienced complications like necrosis, cellulitis, seroma, hematoma and fistula within two years.
August 2016 – A study published in the Journal of Oral Microbiology examines 36 patients with failed hernia mesh, and finds infected gums and teeth in 33% of the patients, and gingivitis in all of them.
Hundreds of thousands of hernia repair operations are performed every year, both with and without surgical mesh, and many of these operations are completed without any complications. Unfortunately, more and more patients whose hernias have been repaired with synthetic mesh are experiencing serious side effects, like mesh erosion, mesh infection, bowel blockage, hernia recurrence, and the need for revision surgery, and in many cases, these complications may take months or even years to arise. If you believe you have been adversely affected by side effects of hernia mesh, consult an experienced hernia mesh attorney as soon as possible to explore your possible compensation options. With a qualified product liability lawyer on your side, you can protect your legal rights and seek fair and timely reimbursement for your injuries.