J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh

June 20, 2016 By Brad Perriello Leave a Comment

Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using its Physiomesh flexible composite mesh.

In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after laparoscopic ventral hernia repair.

West Somerville, N.J.-based Ethicon said it believes the higher revision rates are due to a “multifactorial issue,” possibly including “product characteristics, operative and patient factors,” but hasn’t been able to pin down a cause.

“Consequently, Ethicon [has] not been able at this time to issue further instructions to surgeons that might lead to a reduction in the recurrence rate and [has] decided to recall Ethicon Physiomesh composite mesh from the global market,” according to the letter. “Ethicon will not return theEthicon Physiomesh composite mesh product to the market worldwide.”

Patients already implanted with the product should be followed as usual, the company said. The recall does not involve any other Ethicon meshes, including the Physiomesh Open flexible composite mesh, it said.

“Ethicon recognizes the voluntary product recall of the Ethicon Physiomesh composite mesh may be disruptive to your facility and apologizes for any inconvenience this may cause,” the company wrote. A list of the affected product codes can be found here.

Registration is Open for DeviceTalks Boston

Registration is open for DeviceTalks Boston! Join us on June 5-6, 2019, as we explore the trends and technology that are shaping the future of the medical device industry.

REGISTER NOW

Gottlieb wants to fix clinical trials before departing FDA
The FDA has issued new draft guidance to protect human subjects of clinical trials and the data these trials generate. The draft guidance on using a risk-based approach to conducting clinical trials is one of a handful of guidances promulgated by the agency since FDA commissioner Dr. Scott Gottlieb announced his upcoming departure. In a… […]
Toray touts polymer for regenerative medicine
Toray Industries (Tokyo) recently announced that it has created a novel bioabsorbable polymer with skin-like flexibility. Proprietary functional polymer design technology allows the polymer to recover its original shape even after being stretched 10 times the original length, the company explained in a March 14 announcement. Toray also has identified a way to improve the… […]
Thornhill Medical’s ‘simple’ device may save lives
Thornhill Medical’s device to help patients suffering from carbon monoxide poisoning has won de novo clearance from the FDA. Carbon monoxide poisoning occurs when carbon monoxide attaches to the hemoglobin in the blood exactly where oxygen is supposed to attach, reducing the amount of oxygen carried to the brain and other tissues. Toronto-based Thornhill Medical’s… […]
Theranos whistleblower Tyler Shultz to participate in keynote interview at DeviceTalks Boston
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. DeviceTalks is excited to announce that Tyler Shultz will be the closing keynote speaker at DeviceTalks Boston. Shultz will take attendees behind the story that everyone… […]
Study shows catheter ablation for Afib significantly boosts quality of life
Patients who had catheter ablation for atrial fibrillation (Afib) had fewer symptoms, a significant long-term improvement in quality of life and fewer recurrences and hospitalizations than those who received drug therapy alone, according to a government-funded study. The same study showed that catheter ablation appeared no more effective than drugs in preventing strokes, deaths, and… […]
Medical device cybersecurity: It’s time to get real
Medical device makers, regulators and healthcare delivery organizations are increasingly working together to strengthen cybersecurity. But are they doing enough? Almost no one in the medtech industry disputes the vulnerability posed by cyberattacks. How to go about boosting security is another matter – one on which those stakeholders have recently stepped up their collaboration. One… […]
Can a lifetime guarantee boost value-based care?
Swiss orthopedics company Medacta International and Geisinger Health System have said they will pilot a lifetime guarantee program for knee replacement surgeries. The program will cover full costs for screened Geisinger Health Plan members who receive knee replacement surgery while also ensuring reimbursement for any associated future care the patients may incur throughout their lifetimes.… […]
Compounding Solutions launches new tie-layer resin
Compounding Solutions (Lewiston, Maine) recently announced that it has launched a new tie-layer resin for the medical device industry. ReZilok Rx is meant for the manufacturing of multilayer co-extruded medical films and catheter tubing, the company said in a February announcement. Compounding Solutions’ R&D team developed ReZilok Rx as a linear low-density polyethylene grafted with… […]
GI Dynamics touts results of U.K. study
GI Dynamics (ASX:GID) said a retrospective study of its EndoBarrier device for patients with type 2 diabetes and obesity shows a significant reduction in HbA1c, weight, liver fat and cardiovascular disease (CVD) risks as well as a reduction in the need for insulin in some patients. The EndoBarrier device is a plastic gut sleeve designed… […]
Think Surgical, United Orthopedic join forces for global sales
Think Surgical and United Orthopedic have announced a global joint marketing agreement of Think’s Active robotic system and United’s U2 knee system. Think’s Active robotic system consists of a 3D pre-surgical planning workstation and its computer-assisted Active robot. Its use in total knee arthroplasty is the subject of an FDA investigational device exemption study, with… […]
FDA ramps up scrutiny of materials in medical devices
The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances. It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts… […]