Archive for the ‘laminectomy’ Category

Dangers of Robotic Surgery

Friday, October 11th, 2013

An unnerving study by researchers at Johns Hopkins found multiple examples of botched operations that were not reported to the FDA.  The investigators, headed by Dr. Martin A. Makary  an associated professor of surgery at Johns Hopkins , accomplished this  by combining news reports and court records, and concluded that such cases were vastly underreported. The reporting mandate that requires medical device manufacturers and hospitals to report every device-related death and serious injury to the FDA within 30 days simply is dysfuntional or worse.  It is well-known, for example, that reports made to the FDA represent only a tip of the iceberg-this includes events related to drug reactions, drug deaths, device failures, and  other significant, serious or catastrophic results of medical treatment. The “true” reporting rate for drug reactions and misadvnetures has been rated at 10%, but this is clearly a wild understatement considering that drug deaths alone, not counting suicides, exceeded auto accidents, at 40,000 a year.

Robotic-assisted surgery has taken off, increasing more than 400%  in the U.S. between 2007-2011. A leading company, Intuitive Surgical Inc. the manufacturer of  da Vinci systems sold over 1,400 such systems costing between $1.5million-$2.5 million to scores of hospitals according to Intuitive’s Investor Reports. Between January 2000 and 2012 thousands of mishaps were reported to the FDA.  Among reports were 174 injuries and 71 deaths related to the da Vinci surgery system.

Reported in the New York Times, Sept. 10, the expansion of robotic surgery “has occurred without proper evaluation and monitoring of results,”said Dr. Makary, and senior author of the above study, who added,  “We adopt expensive new technologies, but we don’t even know what we’re getting …if it’s for good value or harmful…Because the reporting mandate has no teeth, he said, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement, and no consequences.”

This is unfortunately true for other implanted devices, in particular cardiac stents and pacemakers. See my previous blog 11/6/2009. “Medical Devices: Disturbing News” (blog page 4).  As for medical devices in general and their poor oversight by the FDA because of failures of reporting, how about reducing the excise taxes on them to satisfy anti-Obamacare politicos?

 

Copyright 2013   Mathemedics, Inc.

Low Back Pain is In

Friday, December 5th, 2008

Back pain is the third most common symptom reported by patients, and costs Americans over $35 billion a year. Low back pain (LBP) affects up to 75% of Americans at some time during lives. It is largely a self-limiting problem, with 9 out of 10 patients recovering within six weeks, and nearly 3 out of 5 patients returning to work within one week. Sciatic symptoms, characterized by one-sided pain, numbness, or tingling radiating to the buttock, sometimes down the back of the leg or into the ankle and foot, may occur in 30% of cases of acute low back syndrome. The likelihood of a herniated (ruptured) lumbosacral disc is increased when acute or recurrent episodes of low back pain persist for more than 4-6 weeks and when sciatica is severe.

In a study of 98 normal patients without back complaints, two thirds had protruding, degenerating, or bulging disks on MRI, and a third had more than one abnormality. Even when patients with back pain have an abnormal MRI the pain often goes away. Similarly, abnormalities are seen in a large number of CT scans in patients without back pain, and X-ray findings of “degenerative changes” are reported in a high percentage of patients without back complaints.

Back pain, especially of the lower spine, has been treated with almost every known modality including, but not limited to bed rest, narcotics, exercise, immobilization, traction, massage, muscle relaxants, epidural injections, surgery, etc. Yet for all the hours and money spent on acupuncture, massage, manipulation, doctor visits, let alone surgery, in study after study, leading medical experts continue to ask what, if anything is doing any good. Since LBP is self-limiting but recurrent about 90% of the time, it is important to learn how to self-treat and avoid attacks by proper care of the back.

Like heartburn and headache, back pain has always been around but there is no evidence of any explosion of new cases. Rather, the cost per case is increasing without any convincing proof that patients are better off. What have changed are people’s expectations. According to Dr. Richard Deyo, a Professor at the University of Washington, “People say they are not going to put up with it, and we in the medical profession have turned to ever more aggressive treatments, more surgery and more invasive surgery.” This includes many of the newer, controversial techniques of spinal fusion using surgical implants, intervertebral cages, pedicle screws, etc.

According to the American Academy of Orthopedic Surgeons, there are approximately 200,000 spinal surgeries (laminectomies) performed every year. An estimated 20% -30% are reported to be unsuccessful, with a reoperation rate of 10%-25%. This high rate of failure is related in most cases to the choice of surgical treatment over conventional “watch and wait” strategies, and often driven by patient demands to be “fixed ASAP,” as observed by Dr. Deyo.

One of the most enlightening discussions on current thinking about surgical treatment and management of spine and back problem is by Dr. Thomas J. Errico, President of the North American Spine Society.  In a letter to the Editor of the New York Times, Dr. Errico, said: “Treatment of the patient with spine problems is an art based in science. It is vital to note that back pain can have a wide variety of causes. A survey of our members indicates that 90% of the care they provide is nonoperative. Surgery is usually the last resort (absent clear neurologic indications or acute incapacitating pain). Still controversies do exist – what one doctor might think is appropriate treatment another doctor might think is inappropriate. Often what they disagree on is the timing of an intervention.”