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Ethicon Media Monitoring 12/14/2018
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Why We Remove Mesh
Dec 13, 2018 | The Legal Examiner
By Jane Akre
A leading hernia mesh doctor reports that her California office is being inundated with requests for hernia mesh removals. -
Global Investigation into Medical Devices Exposes Flaws in FDA, International Regulators
Dec 13, 2018 | Healthcare Analytics News
By C. Gourarie
In 2014, a Dutch journalist used a bag of mandarin oranges to fool European medical device regulators. Jet Schouten submitted the grocery store netting to three regulatory bodies, claiming it was a vaginal mesh.
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Dec 13, 2018 | The Legal Examiner
By Jane Akre
A leading hernia mesh doctor reports that her California office is being inundated with requests for hernia mesh removals.
Dr. Shirin Towfigh is the principal investigator among researchers reporting on the conclusion of a 4.5 year study on mesh removals, published in Hernia Magazine December 2018.
The group removed 105 meshes mostly from men (58%). While men had hernia mesh removed from the pelvis, women had it removed from the abdomen. The average age was 53 years.
Pain was the most common reason for abdominal and pelvic pain removal with a pain score ranging from 5 to 10.
Ninety percent of mesh removed was polypropylene-based, followed by a composite of PP and ePTFE (6%). Polypropylene is an inexpensive polymer commonly found in indoor-outdoor carpets and on Tic-Tac boxes.
Polyester made up 4% of removed meshes then plain ePTFE (3%), biological mesh such as porcine, bovine or human dermis (2%), and a hybrid mesh such as Cook Medical Zenapro (1%).
It is known that nearly all hernia mesh, once infected, will continue to be infected until it is removed. It is very difficult to cure. The infection can develop into a biofilm which is an ecosystem of bacteria.
The mutations can become antibiotic resistant and are able to survive at levels 100 to 1,000 times higher once biofilm is formed.
There are currently hundreds of thousands of U.S. patients with an infected hernia mesh. At the same time, there is very little literature about mesh removal. Most focus on mesh infections, which almost always require a removal.
Meshoma was first termed by Dr. Parviz Amid and describes the problem of folding or balling up of mesh. That contributes to chronic pain, hernia recurrence, and/or nerve entrapment.
Meshoma was found in 38% of Dr. Towfigh’s patients. Most who had a meshoma presented with pain (95%) and / or hernia recurrence (17%).
In the pelvis, some had associated nerve entrapment requiring neurectomy, or surgical removal of a nerve.
Researchers recommend, when evaluating for patients with post-surgical pain, hernia recurrence, and or neuralgia or pain along a nerve, a diagnosis of meshoma should be ruled out as the primary cause.
In her practice at Beverly Hills Hernia Center, Dr. Towfigh generally sees 13% of the practice dedicated to mesh removal. In 2017, that number increased to 22%. She says it’s unclear if this trend will continue and whether there is a national increasing trend in patients requiring mesh removal.
https://herniamesh.legalexaminer.com/health/medical-devices-implants/why-we-remove-mesh/
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Global Investigation into Medical Devices Exposes Flaws in FDA, International Regulators
Dec 13, 2018 | Healthcare Analytics News
By C. Gourarie
In 2014, a Dutch journalist used a bag of mandarin oranges to fool European medical device regulators. Jet Schouten submitted the grocery store netting to three regulatory bodies, claiming it was a vaginal mesh. All three bodies approved the product.
That experience led to the Implant Files, a global investigation and database from the International Consortium of Investigative Journalists that looks at how medical devices are approved and recalled in 36 countries — and how a lack of reporting and transparency can lead to patient harm.
In the United States, a decade of data from the Food & Drug Administration revealed more than 80,000 deaths and 1.7 million injuries potentially linked to medical devices, based on reports to from patients, doctors and medical device companies.
Healthcare providers are the vanguard in the medical device industry. And while the majority of approved devices — from breast implants to pacemakers — are improving lives, the investigation demonstrates that it is crucial for healthcare providers to be selective in vetting devices, in order to protect patient safety and their own investment.
At issue is both how medical devices get approved, and how problems are reported once they’re in use.While the FDA has stricter guidelines than those in other countries, medical devices do not need to undergo clinical trials. The majority of devices — over 95 percent, according to the Associated Press — are fast-tracked to market under a process in which companies need only to prove that they are “substantially equivalent” to a product already on the market, even if that product is decades old, or has a history of problems. (The FDA is taking steps to overhaul the predicate process.) The agency has banned only two devices in more than four decades, according to the AP, and the average time for approval has decreased from more than 250 days two decades ago, to less than 100 today, according to the Implant Files.
In terms of tracking problems with devices, the FDA relies on reports from healthcare providers and device makers, who are supposed to file an adverse event reports when a device is suspected of malfunctioning or contributing to health problems. But the self-reporting can lead to flawed and incomplete data.
A primary example are insulin pumps, which are second only to metal hip replacements in the number of problems reported to the FDA, and yet many patients remain unaware of the potential risks. That’s because in many cases companies point to incorrect use as the source of the problem rather than their devices. Over the last decade, more than 100 lawsuits have been filed against Medtronic, which makes insulin pumps and pump parts, alleging pulp malfunctions, the investigation found. More thanr 150,000 reports have been submitted to the FDA involving Medtronic products since 2008. But in all those reports alleging injury or death, the company only documented a specific problem in 2 percent of cases, and in 80 percent they claimed that they could not determine the cause of the problem.
In November, the FDA put out a statement regarding its strategy for post-market safety of medical devices. According to the statement, the agency approves roughly 12 devices a day, after a careful determination “based on valid scientific evidence” that the devices are safe. The statement outlined ways for better post-market surveillance of medical devices, saying that better data is “one of the core pillars” of their safety plan.
The agency also ramped up its efforts to boost the cybersecurity of medical devices, which are increasingly interconnected to sensitive systems.
A final issue addressed by the investigation is the international implications of problems, which might go reported in one country and unnoticed in others. To that end, the authors of the Implant Files published a searchable database with records on medical recalls from all the countries involved in the investigation.
https://www.hcanews.com/news/global-investigation-into-medical-devices-exposes-flaws-in-fda-international-regulators
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