Tagged Articles

hernia mesh 18 articles

Is Physiomesh ‘Substantially Equivalent’ to Prior Devices?

Physiomesh, a now-recalled hernia repair mesh, is not substantially equivalent to prior devices despite FDA 510(k) approval, according to lawsuits filed that claim the device is linked to injuries and high revision rates. Physiomesh is a polypropylene mesh that is designed to assist in the repairing of a hernia. The mesh was approved by the U.S. Food and Drug Administration (FDA) using a 510(k) approval, which is a fast-track approval method that allows a product to be marketed as long as it is “substantially equivalent” to a device already approved. Ethicon, a subsidiary of Johnson & Johnson and the maker ... Read More

Ethicon blames Physiomesh failures on many factors

The high failure rates associated with Ethicon’s Physiomesh hernia repair mesh is due to a “multifactorial issue,” the company admits. The Florida Record reported that in a lawsuit filed late last year, Ethicon began admitting that there were problems with its hernia mesh product. Ethicon is a subsidiary of Johnson & Johnson. The lawsuit was filed by Joanne Quinn, who was implanted with Ethicon’s hernia mesh product in 2014 for treatment of an abdominal hernia. She reports the pain worsened after the surgery and says she began experiencing diminished bowl motility and painful bowel obstruction. A year after being implanted with Physiomesh, Quinn underwent another ... Read More

Physiomesh patient intestines push through hernia mesh

A Georgia woman has filed a lawsuit against Johnson & Johnson and subsidiary, Ethicon, after her intestines pushed through their hernia repair mesh device, Mass Tort Nexus reports. Connie Franklin and her husband, Marvin Franklin, are accusing the companies of negligence, failure to warn, defective design, as well as loss of consortium. Franklin was implanted with a Physiomesh device measuring 20 cm by 25 cm in an attempt to repair an incisional hernia. Franklin said after the surgery she experienced severe pain as well as nausea and vomiting. On Aug. 1, 2016, she underwent an additional surgery for the hernia that recurred. The lawsuit ... Read More

Hernia mesh maker Sued Over ‘Debilitating Pain’

A Canadian woman is suing the maker of her hernia mesh device after she says she began experiencing debilitating pain, CTV News reports. Two years ago, Naomi Leichner was surgically implanted with a PerFix mesh made by Bard to repair a hernia in her groin. She says she has since suffered agonizing pain at the surgery site and n her back, as well as multiple infections. Her doctors blame the mesh. Despite the constant agony Leichner says she endures, the doctors are unable to remove the mesh because of its close proximity to her femoral artery. Attempts to remove the hernia repair device ... Read More

Physiomesh Marketed without Adequate Testing

Physiomesh, a hernia mesh device made by Johnson & Johnson and its subsidiary, Ethicon, was approved by the FDA in a 510(k) process, which allows the company to fast-track the product onto the market without adequately testing the product for safety and efficacy, according to The Ring of Fire Network. Many lawsuits have been filed alleging failed Physiomesh devices are connected to serious injuries. Claims have been filed by a Florida woman who says she suffered excruciating pain as a result of the mesh, a Canadian woman who describes her pain as if her “insides are going to explode,” and a Louisiana woman who ... Read More

Lawsuit alleges Physiomesh failure

A Florida woman filed a lawsuit in January against Johnson & Johnson and subsidiary, Ethicon, alleging the failure of its Physiomesh hernia repair mesh device required a patient to undergo revision surgery. The Daily Hornet reports that on Feb. 3, 2016, Sarah Ann Gilman had a Physiomesh device implanted laparoscopically to repair a ventral hernia. After the surgery, Gilman began experiencing significant pain, and returned to have doctors check for any issues. She was found to have complications allegedly linked to the hernia mesh, including an abdominal bulge, a recurrent hernia, and mesh adhesion failure. Revision surgery was required, but the issue can never ... Read More

Hernia Mesh Is Defective, Lawsuit Claims

A Lackawaxen, Pennsylvania, couple is suing Johnson & Johnson and its subsidiary, Ethicon Inc., claiming injuries related to a defective hernia mesh product. Robert Mead and Patricia Mead filed a lawsuit on May 8 against the medical device manufacturing giant alleging the company produced a defective product for hernia treatment that has resulted in chronic pain, the Pennsylvania Record reports. The complaint, filed in the U.S. District Court for the Middle District of Pennsylvania, states that Robert Mead, who received Ethicon’s composite mesh for hernia treatment, has experienced serious physical injuries caused by the hernia mesh. Robert and Patricia want J&J and Ethicon ... Read More

Woman says Physiomesh stretched, hernia recurred

A Canada woman says the Physiomesh hernia repair mesh used to repair her hernia”stretched out,” resulting in her hernia recurring, more painful than before. Colleen Copeland is a 34-year-old Canadian who had hernia surgery in February 2016. Doctors repaired the hole in her abdomen left after the surgery with plastic hernia mesh, called Physiomesh, made by Ethicon, a subsidiary of Johnson & Johnson. She says the mesh has since stretched, leaving her in excruciating pain. “The pain is always there. It feels like my insides are going to explode,” Copland told CTV News. “If I cough or sneeze I have to hold my stomach. It is a ... Read More