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Metal Hip Patients Still Know Little About Device Failure and Revision Rates

It has been three years since Johnson & Johnson (J&J) recalled its all-metal ASR hip implant worldwide, but fewer than 10 percent of the 4,500 Indian patients implanted with the device have approached the nation’s redressal agency.

Food and Drug Administration commissioner Mahesh Zagade suggested to the Times of India that the lack of response proves how little Indian citizens know about hip implant procedures or the possible ramifications of surgery. Zagade recommended that non-governmental organizations (NGOs) should take the initiative to educate patients. More Metal Hip Patients Still Know Little About Device Failure and Revision Rates

Intuitive Surgical Warns of Potential Friction Buildup in da Vinci Surgical Robot

Intuitive Surgical warned doctors this week that friction, in certain circumstances, can form in the arms of some of its $1.5 million da Vinci Surgical System robots, which likely would cause the unit to stall. This marks the second warning from the company about its surgical robot in a month.

Intuitive issued an “urgent medical device recall” November 11 alerting customers to the problem, which impacts 1,386 systems worldwide. The U.S. Food and Drug Administration (FDA) said the stalling can occur during a sudden “catch-up” if the surgeon pushes through the friction-caused resistance, according to Bloomberg News. More Intuitive Surgical Warns of Potential Friction Buildup in da Vinci Surgical Robot

Another da Vinci Surgical Robot Analysis Spotlights Increases in Deaths, Adverse Events

When the da Vinci Surgical System robot was cleared by the U.S. Food and Drug Administration (FDA) for use in 2000, it was hailed as one of the medical breakthroughs of the 21st Century. The machine’s manufacturer, Intuitive Surgical, told the public that robotic surgery meant shorter recovery times and fewer adverse events.

For a growing number of patients, robotic surgery has proven to be anything but a step up from alternative surgical methods. There are stories of patients bleeding profusely from robots nicking blood vessels; as well, common injuries include burns, punctures, and tears. Injuries cased by the da Vinci have become so common and serious that the American College of Obstetricians and Gynecologists issued a statement saying that “robotic surgery is not the only or the best minimally invasive approach to hysterectomy…nor is it the most cost-effective,” according to the Wall Street Journal (WJS). More Another da Vinci Surgical Robot Analysis Spotlights Increases in Deaths, Adverse Events

Report Confirms Link Between PODs and Rising Rate of Spinal Fusion Surgeries

A report conducted by three U.S. Senators confirms that doctors who have some type of financial relationship with a spinal medical device company are likely to have performed spinal fusion surgeries at a heightened rate compared with doctors without such relationships.

U.S. Senators Orrin Hatch (R-Utah), Max Baucus (D-Mont.), and Chuck Grassley (R-Iowa) said a new report from the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) found the correlation between Physician Owned Distributorships (PODs) and the increase in surgeries, and warned that this relationship was putting patients’ health at risk, Finance.Senate.gov reported. The senators also noted that unnecessary surgeries are costing taxpayers money through increased billings to the Medicare program.

More Report Confirms Link Between PODs and Rising Rate of Spinal Fusion Surgeries

No Preemption: Medtronic Must Face Faulty Defibrillator Lead Charges

An Indiana appeals court ruled that Medtronic Inc. is not allowed to use preemption to avoid a negligence lawsuit filed over a failed Transvene defibrillator lead.

The Court of Appeals of Indiana recently ruled against Medtronic’s bid for summary judgment. Medtronic had argued that federal preemption laws prohibited the negligence claim filed against it by the family of David Malander Sr., MassDevice.com reported. Malander alleges that he received a Medtronic defibrillator and the Transvene lead in 1997 and that the defibrillator was upgraded in 2004. However, the lead was left in place despite nine cases of random short V-V intervals (false positive tests), MassDevice.com reported.

More No Preemption: Medtronic Must Face Faulty Defibrillator Lead Charges

Colorado Surgeon Faces da Vinci Robotic-related Lawsuit

A Colorado surgeon has been charged with 14 counts of unprofessional conduct for operations he has conducted with Intuitive Surgical’s da Vinci surgical robot.

Warren Kortz, a general surgeon on the medical staff at Porter Adventist Hospital in Denver, was touted as being among the first in the region to use robotic surgery to remove gall bladders through one small incision in the belly button, Bloomberg.com reported. Kortz believes the surgical robot will revolutionize medicine. However, he and many others are alleged to be downplaying the risks associated with use of the da Vinci surgical robot.

More Colorado Surgeon Faces da Vinci Robotic-related Lawsuit

Blood Clot Numbers Not Indicative of Hospital Quality

A new study suggests that the bigger the number of patients who form blood clots following surgery, the more high-quality the hospital is, which is the exact opposite of what has traditionally been thought about this correlation.

Researchers from Northwestern University and Northwestern Memorial Hospital in Chicago found high-quality hospitals and those that routinely test for the complications tend to have higher rates of blood clots than lesser-quality hospitals because those do not check for clots as often, Reuters reported. Lead author Dr. Karl Bilimoria told Reuters that typically a higher complication rate means you’re not doing a good job; however, in this case it’s the opposite.

More Blood Clot Numbers Not Indicative of Hospital Quality

California Court Denies Stryker, Medtronic Motions to Dismiss Lawsuit on Preemption

A California state court denied a host of motions aimed at dismissing a lawsuit filed against Stryker and Medtronic bone proteins, ruling that federal law does not preempt the case from proceeding.

April Cabana filed a lawsuit against Stryker and Medtronic, alleging that the medical device companies participated in off-label promotion of bone graft products, MassDevice.com reported. Cabana also sued the hospital and surgeon Dr. Ali Mesiwala for failing to let her know that they were using the products in an experimental way. Cabana claims she received Stryker’s OP-1 Putty and its Calstrux bone-filler during surgery to alleviate her back pain, MassDevice.com reported. The combination of the OP-1 putty and Calstrux bone-filler had never been studied or approved by the U.S. Food and Drug Administration (FDA), according to the lawsuit.

More California Court Denies Stryker, Medtronic Motions to Dismiss Lawsuit on Preemption

Around 13 Possibly Exposed to Rare Brain Disease via Contaminated Surgical Equipment

Exposure to potentially contaminated surgical equipment used at a New Hampshire hospital has put at least 13 people at risk of developing a rare and fatal brain disease known as Creutzfeldt-Jakob Disease (CJD), state health officials announced Wednesday.

Eight neurosurgery patients in New Hampshire and five in other states were notified they may have shared equipment with a patient who died from CJD – a disabling, fatal disorder that attacks the nervous system. That patient is believed to have had a sporadic form of CJD, a disease that happens spontaneously. It is not connected to the variant form of CJD, otherwise known as “mad cow disease,” which occurs after a patient eats contaminated beef. The only way to diagnose the disease is through an autopsy, according to NBCNews.com. More Around 13 Possibly Exposed to Rare Brain Disease via Contaminated Surgical Equipment

Pediatric Heart Surgery Mortality Rate at Kentucky Children’s Hospital Kept Secret, Riling Parents

Kentucky Children’s Hospital has gone out of its way to keep the public in the dark about its pediatric heart surgery mortality rate.

According to CNN, a host of reporters, as well as the Kentucky attorney general, have requested the mortality data and the hospital has declined to give it to them. The hospital even went to the courts to ensure their numbers were kept secret. In April, Kentucky Children’s Hospital went to court to keep the mortality rate private. The secrecy has led parents of babies treated at Kentucky Children’s to become suspicious something at the hospital has gone awfully wrong.

More Pediatric Heart Surgery Mortality Rate at Kentucky Children’s Hospital Kept Secret, Riling Parents