Ethicon Physiomesh Composite Mesh Recalled Because of High Rate of Complications
On May 25, 2016, Johnson & Johnson issued an “Urgent Field Safety Notice” to warn of the higher rates of recurrence/reoperation after laparoscopic ventral hernia repair using the Ethicon Physiomesh Composite Mesh. Ethicon’s Physiomesh was a leader of global sales in the laparoscopic hernia repair surgeries from the time it was brought to market in early 2010 until it was voluntarily recalled in May 2016.Lawsuits are currently being filed against Johnson & Johnson, the manufacturer of the Ethicon Physiomesh Composite Mesh as a result of the injuries and complications that occurred as a result of this high rate of recurrence and reoperation.
According to Physiomesh lawsuits that have been filed in several states, Johnson & Johnson should have reported the deaths and serious injuries that occurred as a result of the Physiomesh product to the FDA.
Higher risk of recurrence of hernia or reoperation rates with the Ethicon Physiomesh Composite Mesh were originally identified by two application-oriented outcome tools created to track nation-wide surgical outcomes after groin hernia repair. The Danish Inguinal Hernia Database and the Herniamed German Registry allow all institutions to actively monitor the surgical quality and outcomes of products used in hernia repairs. Both the Herniamed German Registry and Danish Hernia Database – DHDB noted higher-than-expected rate of recurrence and reoperations in patients who used Ethicon Physiomesh in their hernia repair as opposed to other mesh products.
|Hernia Recurrence||Adhesion (Scar-like tissue that sticks tissues together)|
|Obstruction (blockage of the large or small intestine)||Bleeding|
|Mesh Shrinkage (contraction)||Perforation (hole in neighboring tissues or organs)|
|Mesh Migration||Seroma (fluid build-up at the surgical site)|
|Fistula (abnormal connection between organs, vessels or intestines)|
The recalled mesh was commonly the cause of bowel perforation and obstruction complications. Once there is migration of the mesh and particularly erosion, surgical procedures to fix the complications are generally necessary. These surgical procedures often require a staged operation and a large recovery time.
What is a Laparoscopic Hernia Repair?
In laparoscopic surgical hernia repair, the surgeon makes several small incisions in the abdomen that allows surgical tools to be inserted into the opening and the hernia is repaired. In many cases, surgical mesh is place over the defect to reinforce the wall of the organ.
Laparoscopic surgery is often recommended because it allows individuals to get back to work quicker and generally causes less pain. Generally, the chance of a hernia coming back after laparoscopic surgery ranges from 1 to 10 out of 100 surgeries done, but as noted in the Physiomesh lawsuits, the rate of hernia recurrence was much greater with the Physiomesh hernia patch than with other mesh products used.
Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. It is generally made from flexible, non-absorbable polypropylene (plastic) filaments that are woven into a fabric.
Was The Hernia Mesh Used in My Hernia Repair Recalled?
It is important to note that Ethicon Physiomesh recall involved only the Ethicon Physiomesh Composite Mesh product line, it did not include the Ethicon Physiomesh Open Flexible Composite Mesh Device, which remains on the market today.
The Ethicon Physiomesh Open Flexible Composite Mesh Device was FDA approved on October 23, 2014 under a 510(k) process in which it was shown by Johnson & Johnson to be “substantially equivalent” to Ethicon Physiomesh’s Composite Mesh – the very device that Johnson & Johnson just recalled. Under a 510(k) application, the FDA does not require the device to submit clinical trials to prove effectiveness. Instead, it is assumed to be as safe as the previous device on the market.
Since the device Ethicon submitted as “substantially equivalent” to their new mesh hernia product has been recalled, many now wonder about the safety and effectiveness of the Ethicon Physiomesh Composite Mesh.
Recalled Ethicon Physiomesh Composite Mesh Products
|Product Name||Product Code||Description / Size||Product Lot|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY0715R||Rectangle 7.5cm x 15cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1015V||Oval 10cm x 15cm||All unexpired lots impacted by this voluntary productrecall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1515Q||Square 15cm x 15cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY1520R||Rectangle 15cm x 20cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH ™ Flexible Composite Mesh||PHY1520V||Oval 15cm x 20 cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2025V||Oval 20cm x 25cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2030R||Rectangle 20cm x 30cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY2535V||Oval 25cm x 35cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY3035R||Rectangle 30cm x 35cm||All unexpired lots impacted by this voluntary product recall.|
|ETHICON PHYSIOMESH™ Flexible Composite Mesh||PHY3050R||Rectangle 30cm x 50cm||All unexpired lots impacted by this voluntary product recall.|
|Product Name||PROCEDURE PACK PRODUCT CODE||ETHICON PHYSIOMESH MESH PRODUCT CODE||Product Lot|
|Laparoscopic Hernia Pack||ELH5||PHY1515Q||All unexpired lots impacted by this voluntary product recall.|
|Laparoscopic Hernia Pack||ELH10||PHY1515Q||All unexpired lots impacted by this voluntary product recall.|
If I believe my mesh product was recalled what should I do?
The voluntary recall of the Ethicon Physiomesh Composite Mesh product has been communicated to doctors, therefore, the best thing to do is to speak to your physician and continue to follow up as instructed.
TruLaw encourages all individuals harmed by devices such as in the case of a hernia mesh to report the side effects and complications to the FDA. Do not assume that the FDA knows about your complications! Learn how to submit your information to the FDA.
Should You File Hernia Mesh Lawsuit To Protect Your Legal Rights?
Did you undergo hernia surgery?
It may be possible the defective hernia mesh was used to repair your hernia.
Did you then develop complications or serious injury?
If you answered yes to these two questions you should look into your legal rights. Fill out our secure form below to find out if you are eligible for mesh litigation and potential compensation for your injury.
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