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In a May 25 letter to healthcare providers, Ethicon said it’s pulling the mesh after a review of unpublished data from a pair of European registries revealed the discrepancy between Physiomesh flexible composite and the other meshes in the registries after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

From the Hospital Bed to the Finish Line

Heidi Dohse was diagnosed with a rare arrhythmia in 1982 and has been 100% pacemaker dependent for over 30 years. With the help of wearable devices, she has been able to pursue her dream to become a competitive cyclist.

You can hear her story and more when you register for DeviceTalks Boston, October 8-10.

REGISTER NOW

Use code FINISHLINE to save an additional 10%.

What is a lithium thionyl chloride battery and how does it work?
Sol Jacobs, VP and GM, Tadiran Batteries What is a lithium thionyl chloride battery? Under the broad category of primary lithium battery types, numerous types of primary (non-rechargeable) lithium battery chemistries are commercially-available that differ in their performance characteristics. The critical considerations are voltage, discharge current, service life and temperature range. LiCFX (poly carbon monofluoride) and LiMN02 […]
Integrated Computer Solutions launches Boston UX firm
Integrated Computer Solutions recently launched Boston UX, a user experience design consultancy that specializes in developing intuitive interface design for smart devices like medical devices, industrial controls and IoT and consumer devices. Boston UX was created as a result of ICS seeing an increasing demand for UX design services over the last three years. The […]
The 20 largest medical device companies in the world
The medical device industry saw even more consolidation over the past year, as evidenced by Medical Design & Outsourcing‘s newest Big 100 list. It used to be that a company had to have at least $100 million in annual revenue to make it on the list. This time around, No. 100 on the list is […]
Saranas demonstrates Early Bird in first endovascular cases
Saranas said today that the first clinical cases using its Early Bird endovascular bleed monitoring system were performed at Atlantic Health System’s Morristown Medical Center in Morristown, N.J. The Early Bird device includes a vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally injured during endovascular procedures, […]
MedAutonomic implants device to treat metabolic syndrome
MedAutonomic said today it has successfully implanted a brain neuromodulation device, the Phoenix, into the stomach wall of a human through an innovative digestive endoscopic procedure. Powered without a battery, the Phoenix sends signals to the limbic system to reset an imbalance in the autonomic nervous system to treat metabolic syndrome and functional diseases such […]
Meditech Spine wins FDA nod for spinal implant system
Meditech Spine said today it has received FDA 510(k) clearance to market the CURE Opel-C Plate spinal implant system, an add-on technology to its already cleared CURE anterior cervical plate (ACP) system and Talos-C hydroxyapatite (HA) interbody systems. With this approval, Meditech will now offer two additional CURE ACP plating options with its Talos […]
Zavation, PanMed join forces in spinal device market
Spinal hardware and biologics company Zavation Medical Products (Jackson, Miss.) said today that it has partnered with the management team of Pan Medical U.S. Corp. to buy that company. PanMed (Tampa, Fla.) designs, develops and manufactures highly complex medical products including balloons, catheters, needles, and instrument kits used in minimally invasive procedures, primarily in kyphoplasty […]
Freudenberg Medical touts catheter handle platform and steerable introducers
Freudenberg Medical is touting its new catheter handle platform and its steerable introducer products. The Composer XL Deflectable Catheter Handle Platform gives users a commercialization-ready interface that is designed to give integrated control, according to the company. It is sized for large bore structural heart and endovascular devices like transcatheter tricuspid and mitral valve delivery […]
Livongo touts first connected BP monitor
Consumer digital health company Livongo Health today announced the first cellular-enabled blood pressure monitoring system in the U.S. Cellular connectivity allows for easy checking and reporting from home, eliminating the so-called “white coat” syndrome that leads to unnecessary prescriptions for high blood pressure, the company said in a prepared statement. Nearly 65% of people already […]
BMF Material Technology to use Onshape software for high-precision manufacturing
BMF Material Technology, a provider of micro/nano-scale 3D printing and precision manufacturing, has picked up Onshape’s 3D cloud CAD platform, the companies said today. Officials at BMF (Shenzhen City, China) think Cambridge, Mass.–based Onshape‘s real-time data management platform will enable them to speed up collaboration and communication with customers, helping them optimize their CAD models. Micro/nano-scale […]
Medtronic joins initiative to bring more women into the board room
Medtronic (NYSE:MDT) said today that it joined the Catalyst CEO Champions For Change initiative, pledging to add more women to its executive team and board of directors. The medtech titan teamed up with global nonprofit Catalyst and promised that it would “strengthen the pipeline of women” within the organization using annual reviews and data tracking. Get […]