Defective Medical Devices Tag

Understanding The Dangers Of The Ethicon Physiomesh

Why did the Food and Drug Administration approve the Ethicon hernia mesh, a dangerous medical device that is the subject of thousands of lawsuits and has been linked to at least three wrongful deaths?

The agency, which is supposedly a consumer safety watchdog, approved the Ethicon Physiomesh because it was “substantially similar” to the Prolift vaginal mesh, which was an existing product. Both these medical devices serve basically the same function and they are made from the same basic materials. The Ethicon hernia mesh does have a very thin protective coating, which was apparently enough to convince the FDA that the new product was safe. However, one would think that the Prolift’s history would have given the agency pause. So far, Johnson & Johnson has paid over $120 million in Prolift lawsuit settlements.

IVC Filter Use Falls As Lawsuits Increase

A recent study found a direct connection between legal activity and less-frequent use of dangerous IVC filters.

The most significant decline occurred in heavy litigation areas, according to Dr. Ketan Patel of Rush University Medical Center in Chicago. Between 1993 and 2010, IVC filter implants increased almost 10 percent a year; after 2010, when the Food and Drug Administration issued a stern warning and lawsuits began to pile up, IVC filter use fell by more than 7 percent annually.

More People Pursue Hip Replacement Surgery

As the market for hip implant procedures continue to expand, the number of defective hip implant lawsuits will probably rise as well.

Collectively, Smith & Nephew, Johnson & Johnson, Stryker, and Zimmer Biomet made over $6.5 billion around the world during 2015. An aging population and an increasing obesity rate may drive global sales as high as $9.1 billion by 2024, according to current market research. Over half these sales will probably be in North America, as patients in the developing world often struggle to afford the procedure and also have a hard time finding qualified doctors to perform the surgery. Increasing per capita income may somewhat alleviate these problems.

Trial Set In Ethicon Hernia Mesh Case

The first defective medical device trial regarding the controversial Ethicon Physiomesh, which the manufacturer has voluntarily withdrew from the market, is set for November 2018. The judge originally set a trial date in July 2017, but both parties asked for more time to prepare, citing the "complex issues in this case." The plaintiff in this case, Matthew Huff, was one of the first people to file an Ethicon Physiomesh lawsuit in the United States. In 2013, doctors implanted the surgical mesh into Mr. Huff's body following a hernia procedure. In 2015, after experiencing severe pain, nausea, and other symptoms, doctors told...

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UK Company Hopes To Make Surgical Meshes Obsolete

In a press release, Mediplus says it has developed a “non-surgical alternative” for PoP treatment that avoids “the clinical risks associated with surgical mesh.”

Although they are still legal to use in the United States, surgical meshes were recalled in both Scotland and the UK, because they often cause serious side effects and are not very effective at treating Pelvic Organ Prolapse and other conditions. As opposed to a surgical intervention, Mediplus offers a range of silicone pessaries that lift internal organs to relieve incontinence and other symptoms. Support pessaries, many of which resemble small buttons or pacifiers, are usually ideal for first-time PoP victims.

An estimated 32,000 UK women use pessaries each year.

Government Issues New IVC Filter Warnings

Health Canada recently told doctors to remove IVC filters from their patients to avoid serious, long-term complications.

After receiving over 100 verified reports, the government medical watchdog officially linked the Inferior Vena Cava filter to organ perforation, fragmentation, and other possibly fatal conditions. Additionally, of the two Randomized Controlled  Trials connected with IVC filters, neither of them indicated that these devices were particularly effective, according to the agency. Therefore, Health Canada strongly urged physicians to limit the use of IVC filters to extreme cases only and remove them after a few days. The agency stopped short of issuing a recall, but has demanded additional information about safety and efficiency from at least six manufacturers.

Dallas Jury Awards $1B In Hip Implant Lawsuit

Johnson & Johnson must pay $1.041 billion to six California residents who experienced serious side effects from their metal-on-metal (MoM) hip implants; the jurors declared that the devices were defectively designed and that DePuy Orthopaedics, a division of Johnson & Johnson, failed to adequately warn consumers.

DePuy originally marketed these devices as safe and long-lasting alternatives to ceramic-on-metal (CoM) and plastic-on-metal (PoM) implants. But the plaintiffs experienced serious complications, including bone loss and tissue death. Since the verdict included only $32 million in compensatory damages, the judge will probably reduce the punitive damages award to meet punitive damages caps in Texas law. However, the message is clear, according to lead plaintiffs’ counsel Mark Lanier. Johnson & Johnson has “a really nasty part of their business they need to clean up,” he commented. DePuy stopped selling Pinnacle MoM implants in 2013, and last year, the pharmaceutical giant paid $2.5 billion to settle 7,000 actions related to the similar ASR implants, which were recalled in 2010.

Four Things You Should Know About IVC Filters

Each year over 250,000 IVC filters are implanted into patients at risk for blood clots. Although most patients have no side effects, there are some serious complications with IVC filters. Fact #1: The longer the IVC filter stays in place, the higher the risk of injury. Once the blood clot has passed the IVC filter should be removed. The FDA states the device should stay in anywhere form 29 – 54 days from insertion date for best results. Fact #2: IVC filters have been connected to 27 deaths and counting. A recent NBC News special revealed at last 27 deaths have been linked to...

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