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Ten Deaths Associated With J&J Physiomesh Hernia Mesh

Mesh Medical Device News Desk, December 15, 2016 ~ At least 10 deaths and seven injuries, associated with PHYSIOMESH™ (JNJ) hernia mesh, have been reported to the U.S. Food and Drug Administration (FDA). Device Events worked with Mesh News Desk in preparation of this story.

Civil lawsuits that become mass torts involving many plaintiffs, with similar injuries, tend to run with the trends.

For many years, transvaginal mesh was the top tort. Now, with many of those cases settling, trial lawyers, and their legal referral services, are turning their attention to hernia mesh.

Also made of polypropylene, more than a million hernia repairs are done every year. Recipients are reporting the same complications as transvaginal mesh patients – chronic pain and infection, mesh shrinkage, mesh migration, and organ perforation etc.

Lawyers are focusing specifically on coated hernia meshes, preparing cases for future litigation, specifically Atrium C-Qur and PHYSIOMESH made by Ethicon, a division of Johnson & Johnson (JNJ).  Ethicon voluntarily recalled  PHYSIOMESH from the market in May.

The Urgent: Field Safety Noticenotes two unpublished studies that found PHYSIOMESH™ had higher failure rates for laparoscopic ventral hernia surgeries than other meshes used in a German and Danish Medical Registry.

The Voluntary product recall states unpublished data found, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients in these registries.”

It’s estimated 300,000 patients have been implanted with PHYSIOMESH™ since it was cleared by the FDA for sale via the 510 (k) process in 2010. (here)

The Field Safety Notice says nothing about deaths.

 

TEN DEATHS ASSOCIATED WITH PHYSIOMESH™

Device Events, is an investigative tool that uses proprietary algorithms designed by developer Madris Tomes. Formerly with the FDA, Tomes investigates under-reported or mis-reported entries to the complication databases of the FDA to look for patterns of injury or death.

In all, Ms. Tomes shared 7 injury and 10 death reports associated with PHYSIOMESH™ hernia mesh with Mesh Medical Device News Desk.

“While the FDA requires manufacturers and hospitals to report deaths due to devices, if there is any leeway or room for interpretation, often the reports come in as injuries or malfunctions. Tens of thousands of deaths have been extremely difficult to find due to this regulatory ambiguity and dirty data. This can be the critical data point needed for mesh and countless other medical device cases.”~Madris Tomes, Device Events

Further exploration of deaths and injury via additional search terms (such as manufacturer and a host of search terms used to unearth findings), are available via a subscription to Device Events.

 

MANUFACTURER MUST REPORT ADVERSE EVENTS TO FDA

Hospitals, the manufacturers and importers are required to filed adverse event reports with the FDA. Lawyers, doctors, and patients may file an adverse event report to the FDA.  See how to here

An Adverse Event report means the device “may” have caused or contributed to death or serious injury, according to Isaac Chang, Ph.D, Director of the Division of Postmarket Surveillance with the FDA.

Certain malfunctions, such as a product failure, improper design, labeling and manufacturing problems, failure to meet performance specifications and use error must also be reported. Those incidents may have been a factor in a death or serious injury.

 

SEPSIS AND INFECTION

The ten deaths reported to the MAUDE database, almost always involved infection.

Sepsis is the most common word for a bacterial, fungal or viral infection of the bloodstream according to Mayo Clinic hereIt should be treated in the early stages before progressing to severe septic shock which can be fatal, especially in an older person or someone with a weakened immune system.

Its origin can be introduction of an invasive device or injury to the bowel which releases bacteria into the system.

Death reported as injury, FDA

Organs can fail from severe sepsis, gangrene or tissue death.

Bowel violation, says a report on Patient 8. The patient died from sepsis after straps of the mesh were turned into the fascia violating the bowel.

Patient 14 (above) is listed as an injury report, even though it later said the “patient had a  generalized infection and died” after a PHYSIOMESH™  implant and suffering two injuries to the small intestine.

In some cases, initial injury reports are not updated when the patient expires.

Mesh breakage of Physiomesh report to MAUDE

Patient 23 is an injury report with sepsis and the “mesh breaking up” and a “hole in the mesh” necrosis, and “resection of small bowel,” (see above) yet the reporter, JNJ, says the “mesh met the finished goods criteria,” in other words, it did not test as defective.

PHYSIOMESH™ problems have included a failure of the mesh to incorporate with the body, largely blamed on the laminated coating on the polypropylene (PP).

The PHYSIOMESH™ is constructed of knitted filaments of extruded PP with an additional dyed polydioxanone film marker, added for orientation purposes. The coatings were added to each side to avoid contact with tissue and organs and bowel. But with no PP exposed, the hernia mesh may not incorporate into the body, leaving it potentially floating and moving around in the patient.

Also, since less PP was used to make PHYSIOMESH™ “lightweight,” it is considered to be weaker than standard hernia mesh made of polypropylene.

The PHYSIOMESH™ may tear apart as a result, according to trial attorneys pursuing these cases.

NATURAL DEATH

Patient 20 was considered obese with chronic steroid use.

Those are the factors contributing to his surgical site infection and wheezing, according to the entry. The mesh separated and did not adhere to the intestinal loops. Fasciitis and infection were observed.

A new mesh was implanted. He died four weeks after the PHYSIOMESH™ was implanted.

His death was attributed to bronchoaspiration and respiratory failure.

An autopsy was not ordered due to the “natural death.”

When Patient 24 presented with a 104.5 fever following his PHYSIOMESH™ implant, as well as sepsis, he had the mesh removed. In 12 hours, the report says, “the patient got better.”

Two of the reports to the FDA appear to go out of their way to avoid connecting the mesh to the patient’s death.

In the Patient 21 death report, which notes complications and sepsis after a mesh implant, the manufacturer reports there is “no reason to suspect the mesh malfunctioned and caused the patient death.”

Patient 16’s death, J&J reports, is “not related to mesh but to co-morbidity.” The patient had two surgeries, was bleeding from the trocar site and had necrosis of the colon.

Another death report, Patient 17, reports he died six days post-op. The patient was enrolled in a study of patients with peritonitis to prevent incisional hernias. The patient suffered three small bowel resections during the procedure. The patient passed out in the hospital and hit his head. He died after 45 minutes of resuscitation.

 

ETHICON RESPONDS

Ethicon’s newer version of Physiomesh, ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, approved October 23, 2014, remains on the market and is not related to the product withdrawl of PHYSIOMESH.

Here is its 510 (K) report.

Removing PHYSIOMESH™ from the market does not qualify as an FDA recall.

A call to JNJ to respond to these reports had gone unanswered by deadline. Any additional comments will be added when and if they are received. ###

10 Comments

  1. lordhelpus says:

    The crimes keep piling up and no one is being held accountable….the system is failing us… :'(

  2. Kitty says:

    How did they repair hernias in the past? This is crazy…..

    • Jane Akre says:

      Suture repairs were done, but mesh has been around for 60 years or so. If you are a candidate for a suture repair, that is a good first treatment, is my understanding.

      • Still Standing says:

        Or, larger or more significantly placedhernias were not repaired and they can cause death. They become strangulated, or cut off, and blood supply does not get there and the tissue dies, leading to infection and death.

  3. Kathy W says:

    I have had most of the problems associated with Ethicon TVT. I was told last week that the myriad of health problems I have experienced are caused by Sjogren’s. This whole thing just keeps getting worse and worse. I understand that Judge Goodwin has worked diligently to move these cases forward. I have yet to tell my attorney’s about Sjogrens. Have there been others?

  4. Disgusted says:

    I would really like to see some accountability in all of this. My friends father just died in the hospital. He was running a high fever and they did an MRI of the abdomen. They were told he had a mass that needed to be removed. When the doctor went in to remove the mass the hernia mesh was entangled in his intestines and stool. The whole abdominal cavity was infected. They couldn’t do anything, so they sewed him shut and watched him die. He was also a diabetic, which they said was the big issue. Also, my husbands boss was supposed to get hernia mesh. Because of my issues with a TOT my husband talked him out of it. His boss argued with the doctor that he didn’t want mesh. The doctor told him the surgery would take 3 1/2 hours compared to an hour. He said he didn’t care. His hernia was fixed vis a vis stitches. Mesh is so much easier to use, and so much easier to lose your patient too!

    • Jane Akre says:

      I love that that man insisted and got a non-mesh repair. It can be done in many cases…. put it in writing, then it is actionable if the doc does it anyway. !!

  5. Cara says:

    After I had a Caldera mesh implant “partial removal”(of which the biopsy saw nothing but some evidence of refractile material), I almost died from gangrene in the rectum.It was terrifying and has left me unable to work after going to school for a Masters degree for many years.I also now have an autoimmune disorder and fear for my future health.I have constant pain in my groin. My friend told me yesterday that she is having a hernia repair.I am telling her about this so she can ask for a non-mesh repair.There are enough of us suffering, and we don’t need one more.

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