You may think, if a doctor prescribes a medical treatment, it’s been thoroughly tested. For one type of treatment, however, you would be dead wrong. A Consumer Reports’ investigation found medical devices — like defibrillators, joint replacements, and even surgical mesh used to treat hundreds of thousands of women — may not be clinically tested at all.
Dr. Stephen Tower is an orthopedic surgeon. When the arthritis in his hip became too hard to bear, he opted for a metal-on-metal hip. The new hip, however, caused him so much pain, exhaustion, and depression that he had it removed.
The tissues around the hip had been destroyed, and metal debris was spreading down his thigh. Tower says normal friction in the artificial joint caused cobalt, a toxic metal, to be released into his body, leading to serious tissue, heart, brain, and thyroid problems.
Consumer Reports says this particular type of hip, called the ASR XL, was made of chrome cobalt metal, but it was never clinically tested before the Food and Drug Administration cleared it to be sold. Because of high failure rates and complications like Tower experienced, it’s now off the market.
Read more: http://www.ky3.com/news/ky3-consumer-reports-most-medical-implants-have-never-been-tested-for-safety–20120329,0,5914319.story
While metal-on-metal hips have been widely criticized, a Consumer Reports’ investigation found there are other dangerous devices that are being implanted.
Hundreds of thousands of women have had mesh slings inserted to support internal organs as they age, such as the uterus and bladder. Again, those products were never clinically tested before being marketed for that use.
The FDA’s own database shows thousands of complaints about the mesh, including debilitating infections. Yet it’s still on the market and not even classified as high-risk.
Consumer Reports believes the FDA should require rigorous testing for implantable devices, just as it does for prescription drugs.
Consumer Reports also urges creating a national registry to keep track of implanted medical devices and to be able to alert patients if there is a problem. Currently there is no such tracking in the U.S., and it’s estimated only a fraction of device problems actually do get reported
In January 2004, Diane Manganiello, then 42, of Montague, went to a Port Jervis, N.Y., hospital for treatment of a low sodium level. She left with a brain injury that took away much of her physical movement and her speech.
The onetime calculus teacher at Wallkill Valley Regional High School in Hamburg now functions with “the cognitive level of a young child,” said her attorney, Robert Winters.
Earlier this month, a jury in Orange County, N.Y., awarded the Manganiellos $34 million in a 5-year-old medical malpractice case.
Much of the award will pay for around-the-clock care that will let Diane Manganiello live at home, but, her husband says, “It’s not over yet.”
Attorneys for Bon Secours Community Hospital and the doctor and nurse who were sued are appealing, and it’s unclear when the money will be paid.
After his wife was hospitalized, Andrew Manganiello lost his job as sales manager for a printing company in Morristown, because he was spending so much time “running to the hospital every day.” He remained devoted to his wife’s care and finally returned to work last September, employed by the state Department of Labor as a business representative for Sussex County.
Through all these troubles, the couple’s five children — who ranged in age from 12 to 18 back in 2004 — have all gone to college. The three girls went into fields that would enable them to directly help their mother — speech pathology, occupational therapy and nutrition. Meanwhile, the two sons, the oldest of the group, got financial-services jobs and now help their father pay the bills.
The jury accepted the Manganiellos’ contention the hospital — and specifically, the physician, Moinuddin Ahmed, and a nurse, Rose Aumick — created Diane Manganiello’s condition by giving her too much sodium too quickly.
Patients suffering from hyponatremia — or a low sodium level — should have their sodium raised slowly, no more than 10 to 12 units over 24 hours, Winters said. However, Diane Manganiello’s level was raised 27 units in 14 hours, causing irreversible brain damage.
A couple was awarded a $2.3 million from The Justice Department after a medical malpractice suit claimed that inadequate care at a medical center caused their baby neurological damage.
The couple filed the suit against he federal government after the incident occurred at the Portsmouth Naval Medical Center. The government denied any wrongdoing in the incident.
Details of the incident were not given at this time, but the settlement does state that the $1.57 million will be put into a trust fund set up for the child and the rest will go to medial bills and attorney fees.
A hospital in Missouri has admitted that, due to a radiation machine that was programmed incorrectly, 76 patients were given a 50 percent overdose of radiation.
According to hospital officials, the machine was programmed incorrectly after it was installed in 2004. Since then, every patient that has used the machine has been exposed to 50 percent more radiation than needed.
The error was finally discovered when a new technician was being trained to use the machine in September 2009. The hospital is no longer using the device and a full investigation is underway.
Stereographic radiation machines are used to treat small brain tumors and usually only one treatment is necessary.
New research shows that there is a link between interruptions during medical procedures and a higher rate of clinical errors and procedural failures.
The study’s lead author said that the more interruptions that a nurse receives while administering drugs to a patient, the greater risk that an error will occur. The team who did the study, observed 98 nurses in hospitals administer 4,271 medications and found that an interruption occurred in 53 percent of them.
Of the procedures that were interrupted, 74 percent of them had at least one procedural failure and 25 percent had a clinical error. Authors of the study noted that some interruptions are necessary such as monitoring alarms, only 11 percent of the studied interruptions were needed.