From Our 2012 Archives
Health Highlights: March 28, 2012
Latest MedicineNet News
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Report Slams Approval Process for Medical Devices
U.S. regulators approved the Lap-Band weight loss device with little or no advance safety testing, according to a report issued Wednesday by Consumer Reports magazine.
It said the Food and Drug Administration's approval of the device was based on a clinical study of only 299 patients. Of those patients, 25 percent had their Lap-Bands removed before the end of the 3-year study due to complications or failure to lose enough weight.
"Imagine if a car had a recall rate that high. Consumers and regulators would be up in arms," said John Santa, director of the Consumer Reports Health Ratings Center, the Los Angeles Times reported.
Allergan Inc. has sold more than 650,000 Lap-Bands worldwide. Last year, the FDA approved the Lap-Band for use in less-obese patients. The approval was based on a study that showed 80 percent of patients who used the device lost at least 30 percent of their excess weight and kept it off for one year.
The Lap-Band "has been approved internationally since 1993, and as such has a 19-year safety and effectiveness record," Allergan spokeswoman Naziah Lasi-Tejani told the Times.
Consumer Reports also expressed concerns about the safety testing and risks associated with metal hips, surgical mesh and certain cardiac devices.
Allergan and other companies that make medical devices comply with current federal regulations, noted Rita Redberg, a professor of medicine and cardiologist at the University of California, San Francisco. She said it's those lenient federal standards that are the problem.
"What the device industry is doing is certainly legal," Redberg told the Times. "There needs to be congressional action to improve the requirements for the safety and effectiveness of high-risk medical devices. A lot of people have these devices or they are candidates for one."
In a report issued last year, the Institute for Medicine said the current approval process for medical devices is flawed and called on the FDA to develop new regulations to ensure patient safety.
About 17 percent of American adults have an implanted medical device, according to a recent survey by the Consumer Reports National Research Center.
Ruling Allowing Payments to Bone Marrow Donors Will Stand: Court
The legality of allowing bone marrow donors to be paid for their donations will not be reconsidered by a federal appeals court.
In a ruling late last year, the 9th U.S. Circuit Court of Appeals overturned the criminality of paying bone marrow donors, an offence that could be punished by jail time, the Associated Press reported.
The court said a technical advance makes the process of donating bone marrow nearly identical to giving blood plasma. Blood donors can be paid for their donations but payments for donating a kidney or any other organ are illegal.
On Tuesday, the court declined the federal government's request to reconsider the ruling, which is opposed by a number of organizations and activists in the organ-donation community. The government has 90 days to petition the U.S. Supreme Court, the AP reported.
Virginia Man Recovering Well After Face Transplant
U.S. doctors say they've performed the world's most extensive face transplant on a 37-year-old Virginia man who was injured in a 1997 gun accident.
Doctors said Norris is recovering well, beginning to feel his face, is already brushing his teeth and shaving, and has regained his sense of smell.
Norris has lived as recluse for the past 15 years and the face transplant will give him his life back, according to lead surgeon Dr. Eduardo Rodriguez.
"It's a surreal experience to look at him. It's hard not to stare. Before, people used to stare at Richard because he wore a mask and they wanted to see the deformity," Rodriguez told the AP. "Now, they have another reason to stare at him, and it's really amazing."
The world's first face transplant was performed in France in 2005 and the first face transplant in the U.S. was in 2008.
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