Tagged Articles

hernia mesh 18 articles

J&J faces more litigation alleging injuries with Physiomesh

A group of people who claim to have been injured by hernia repair kits made by Johnson & Johnson subsidiary Ethicon USA LLC have asked the New Jersey Supreme Court to consolidate the 62 lawsuits pending against the company into a multicounty litigation, and assign them to Superior Court Judge Rachelle Lea Harrz in Bergen County. Several hundred similar cases are expected to be filed. Those suing Ethicon allege the company designed, manufactured, marketed and sold defective hernia mesh, including Proceed Surgical Mesh, Proceed Ventrical Patch, Ethicon Physiomesh Flexible Composite Mesh, Prolene 3D Patch Polypropylene Mesh, and Prolene Hernia System. ... Read More

Lawsuits claim hernia mesh is defectively designed

Atrium Medical Corp.’s C-QUR hernia mesh products are coated with a fish oil derivative similar to the Omega 3 nutritional supplement, intended to limit adverse effects, but the fish oil along with the defective design and manufacture of the device only worsen the hernia mesh side effects, according to hundreds of people suing the company. More than 335 people have filed lawsuits against Atrium in U.S. District Court in Concord. The lawsuits charge that Atrium hernia mesh caused an “unreasonable risk of severe adverse reactions.” The fish oil did not prevent adverse events from occurring, the lawsuits contend. It created ... Read More

Despite reported Injuries, Hernia Mesh Market Expects Growth

Hernia mesh is becoming an increasingly popular method to repair hernias of all types. According to a recent market report on OpenPR.com, a hernia is a “protrusion of an organ through a weak spot in the surrounding connective tissue.” Additionally, that same report says that the use of hernia repair mesh is a consistently growing market. “Globally, the market is growing steadily and it is anticipated to show an exponential growth reaching approximately $8.5 billion in 2022,” the report states. There are several types of hernias, such as inguinal, incisional, and femoral, many of which can be repaired laparoscopically rather than ... Read More

Study: Use of Synthetic Mesh Leads to Higher Failure Rates

A new study suggests that using a synthetic mesh product to repair a contaminated incisional hernia will likely have a higher rate of failure. According to the study published by PubMed last week, biological mesh should be considered first over synthetic mesh for a potentially contaminated hernia, which has a high rate of failure. Common synthetic mesh material are made from polytetrafluoroethylene or polypropylene, woven to create a kind of fabric that the body is expected to accept internally once implanted. Johnson & Johnson’s Ethicon is currently under fire for its Physiomesh hernia repair device made of polypropylene that has resulted in ... Read More

Physiomesh Found to be Shredded Inside Woman’s Abdomen

A new lawsuit against Ethicon and Johnson & Johnson was filed after a woman’s Physiomesh shredded inside her body. Jo Ann Lax of Lafe, Arkansas underwent a laparoscopic surgery to repair an umbilical hernia on Oct. 27, 2014. The surgeon, Dr. Robert Warner Jr., implanted Lax with Physiomesh 15×15 cm. in size. The mesh was designed to reinforce the tissue affected by the hernia, to allow Lax to return to life as normal. When Lax began experiencing pain at the hernia site, it was determined that the hernia mesh must have failed. On May 28, 2015, Lax underwent an additional surgery to have ... Read More

Study: Fibromyalgia linked to Polypropylene Mesh Implant

Sling the Mesh, a support group made up of people who say they have been harmed by mesh implants, conducted a survey showing 1 in 3 people who have received a polypropylene mesh implant developed fibromyalgia. According to the Mayo Clinic, “fibromyalgia is a disorder characterized by widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues. Researchers believe that fibromyalgia amplifies painful sensations by affecting the way your brain processes pain signals.” The survey questioned 187 mesh implant recipients, and 54 of them – or 29 percent- report they have developed the painful disease of fibromyalgia after receiving a mesh ... Read More

Alabama Man Sues Maker of Hernia Repair Mesh

An Alabama man has filed a lawsuit against the maker of his hernia repair mesh, blaming the defective device for complications that required an additional surgery. The lawsuit was filed by Bill Tedford, who received the Physiomesh hernia mesh device made by Ethicon, a subsidiary of Johnson & Johnson. According to the Daily Hornet, Tedford’s hernia repair surgery was performed in December 2013. The lawsuit alleges Mr. Tedford’s complications and reactions to the mesh device were so severe, an additional surgery and further medical treatment was required. The complaint says he now suffers permanent scarring as well as other injuries associated with the device. ... Read More

More than 800 Physiomesh Incidents Reported to FDA

According to the U.S. Food and Drug Administration (FDA) website, there are more than 800 negatively reported incidents associated with Physiomesh, including injuries and death. The FDA’s MAUDE reporting system allows doctors and hospitals to submit adverse event reports regarding various medical devices and products. Physiomesh yielded 839 results from 2010 to present, most of which reported incidents that resulted in injuries, and many of which resulted in deaths. The number of adverse incident reports have increased significantly every two years. From 2010-2012, only 95 incidents were reported. From 2012-2014, 293 incidents were reported. From 2014-present, 451 incidents were reported. ... Read More

Australian Woman blames hernia mesh for infection

An Australian woman has been awarded a $1 million verdict after she suffered an infection following hernia mesh surgery Kylie Tinnock, a mother of three, underwent incisional hernia repair surgery on June 7, 2010, at  Wagga Base Hospital. The primary surgeon, Dr. Justin Gundara, and specialist general surgeon, Dr. Michael Payne, used a hernia mesh device to assist in repair. On June 15, 2010, a second surgery was required to drain a seroma that had formed. A vacuum dressing was used as a therapeutic technique to promote healing. On June 27, 2010, Tinnock returned for a third procedure in which Dr. Payne closed the abdominal cavity ... Read More

FDA 510(k) medical device approval leaves room for error

The FDA frequently uses a medical device approval method called the 510(k) process, used to hasten a new product to market, but a growing list of reported injuries and complaints indicates the process may not be thorough enough. The 510(k) approval is a fast-track method of gaining permission from the FDA to market and sell a new medical device as long as the product is “substantially equivalent” to a product previously sold on the market. No additional clinical tests are required as long as the manufacturer can prove the new device’s similarities to another product. On May 11, an approval letter was ... Read More