Hernia Mesh Lawsuits
Hernia mesh lawsuits have been filed alleging complications requiring additional surgeries and medication for mesh revisions or removal. Mesh manufacturers are Ethicon Physiomesh, Bard / Davol, Atrium C-Qur, Covidien and others. Complications include:
- Bowel blockages,
- Migration of the mesh,
- Perforation of organs and tissues,
- Erosion of the mesh,
- Hernia recurrence,
- Mesh shrinkage
Physiomesh Hernia Mesh
Physiomesh Flexible Composite Mesh is coated with a gel film not previously utilized in hernia mesh products and was recalled over an alarming rate of complications. Manufacturered by Ethicon, a division of Johnson & Johnson, an urgent field safety notice on May 25, 2016, advises surgeons to stop using the Physiomesh for hernia repair. Lawsuits are consolidated into MDL 2782 before Judge Richard Story in Georgia Federal Court with 647 lawsuits pending. ETHICON PHYSIOMESH FLEXIBLE COMPOSITE HERNIA MESH . The Ethicon Physiomesh multidistrict litigation is IN RE: Ethicon Physiomesh Flexible Composite Hernia Mesh Products Liability Litigation, MDL No. 2782, in US District Court for the Northern District of Georgia, Atlanta Division.
Ethicon’s own medical safety team initiated the product recall in response to the complications documented with Physiomesh. The lawsuits allege the manufacturers knew or should have known about the risks of injuries, yet never warned patients and the medical professionals of the dangers. Despite numerous reports of removal and revision surgeries, infections, adhesions, intestinal blockages, perforations and other serious injuries, the manufacturers refused to notify patients and doctors.
Parietex and Parietene Mesh
Parietex mesh is manufactured by Covidien (acquired by Medtronic in 2015) with multiple products varying in design, pore size, polypropolene or polyester composition, gel layers and microgrips. Other hernia mesh products with unique designs we are investigating are:
- Parietex, Parietex composite associated with infections due to the collagen covering
- Covidien Parietex (Incl. PCO) has been associated with adhesions, pain, bowel obstruction, tearing at edges, swelling, fixation failures
- Parietex Plug and Patch for groin repair
- Progrip, Parietex Progrip, Parietene Progrip are associated with tearing, ripping, fixation issues, recurrence, foreign body presence
- Parietene, Parietene microporous
Bard/ Davol Mesh
Bard offered $184 million to settle 2,600 Kugel patch lawsuits over injuries in June 2011. The Bard/Davol mesh products we are investigating include:
- Composix Kugel Mesh- RECALLED
- Ventralex Mesh
- ST products (Sepramesh) Composix Mesh
- Composix E/X Mesh
- Perfix Plug
Atrium C-Qur Hernia Mesh
Atrium C-Qur Edge Mesh, was recalled by the FDA on February 3, 2015, alleging that Atrium introduced adulterated medical devices into interstate commerce. Lawsuits are consolidated into an MDL in New Hampshire federal court.
Further, the manufacturing, packing, storing and installing were not in conformity with the current good manufacturing practice requirements for medical devices. Various C-Qur mesh products are composed of polypropylene mesh, and gel coating made from omega 3 fatty acids, (O3FA). Other safety notices were issued involving mesh products, including:
- October 11, 2012, the FDA issued a safety warning letter
- August 9, 2013, the FDA issued a Class 2 recall of Edge mesh
- February 3, 2015, the FDA filed an injunction to stop production of certain hernia mesh
Despite the warnings, the manufacturer continued to introduce products for use in hernia repair, chest wall reconstruction and treatment of wounds, including:
- Atrium C-Qur Edge Mesh
- Atrium C-Qur FX Mesh (C-Qur Lite)
- Atrium C-Qur V-Patch
- Atrium C-Qur Centrifx
- Atrium C-Qur Mosaic
- Atrium C-Qur TacShield
The lawsuits allege the manufacturers knew or should have known about the risks of injuries, yet never warned patients and the medical professionals of the dangers. Despite the alarming rates of removal and revision surgeries, infections, adhesions, intestinal blockages, perforations, the manufacturers refused to notify patients and doctors.
Covidien Hernia Mesh Polyester Products
Covidien is a subsidiary of medical device giant, Medtronic, headquartered in Minnesota. Certain hernia mesh products contain a collagen film technology designed to minimize adherence to muscles and organs in ventral and umbilical hernia repairs. However, lawsuits allege that Parietex mesh products are linked to injury and infection leading to additional mesh revision or removal surgeries. From the beginning of Covidien’s entrance into the hernia mesh market, their products did not undergo rigorous clinical studies and scientific testing. The FDA approved the mesh products based on data showing that it was substantially similar to a previous product.
Parietex is composed of polyester, instead of polypropylene. Yet, a study in 1998 published by JAMA, concluded that polyester mesh should not be used in incisional hernia repair due to the myriad of complications. The long term research clearly stated that polyester mesh had a significantly higher mean number of complications per patient, a higher incidence of fistula formation, a greater number of infections, and more recurrent hernias than the other materials used. The additional mean length of stay to treat complications was also significantly longer when polyester mesh was used. The deleterious effect of polyester mesh on long-term complications was confirmed on multiple logistic regression. The technique of placement had no influence on outcome.
Areas of Hernia Mesh
- Inguinal hernia,
- Femoral hernia,
- Umbilical hernia,
- Incisional hernia,
- Epigastric hernia,
- Hiatal hernia,
- Ventral hernia,
- Other traumatic repairs
Do I Have A Case?
With over thirty years of successful litigation, we understand the medical and legal issues you are facing, so call us posthaste to preserve your rights. Our firm has the trial expertise and resources to successfully prosecute these cases to resolution. We don’t warehouse files and can provide attorney client privileged reports to our clients. You can actually speak to a lawyer about your concerns. Medical legal consultations are FREE so contact us posthaste at 1-800-814-4540, fill out the contact form to the right of this page, or email carolyn@carolynstclair. There are statutes of limitation in each state, so contact us for a free consultation before your time runs out.