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The Urgent: Field Safety Notice, notes two unpublished studies that found PHYSIOMESH™ had higher failure rates for laparoscopic ventral hernia surgeries than other meshes used in a German and Danish Medical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The Voluntary product recall states unpublished data found, “The recurrence/reoperation rates (respectively) after laparoscopic ventral hernia repair using ETHICON PHYSIOMESH™ Composite Mesh were higher than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.”
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 here. It 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.
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.
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.
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’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. ###