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Entries in Senate Committee (2)

Wednesday
Apr132011

Senate Committee to Examine FDA's Medical Device Approval Process

Comstock/Thinkstock(WASHINGTON) -- Katie Korgaokar was 36 years old when she underwent an agonizing operation to have hip replaced because of Perthes disease -- a condition that blocked blood supply to her femur during childhood. Little did she know the procedure was just a warm-up for what was to come.

"They had this new, latest greatest hip out there that was going to be perfect for a woman that was smaller," said Korgaokar, who initially hesitated to sign up for such a major procedure. "So I said, whatever you think is best is what we're going to do."

After getting her new hip in November 2006, Korgaokar could hike, ski and ride horses around her Denver home free of pain.

"I wish I'd done it much earlier, because it completely changed my life," said Korgaokar.

But her life soon changed again, when she received a letter last fall stating that her hip was being "voluntarily recalled."

"I thought: that's what happens to cars," Korgaokar said. "It just really seemed like a joke -- you don't recall parts you put in a person."
It was no joke. Korgaokar's hip was being recalled because of a design flaw that her doctor said could leech chromium and cobalt into her body.

"You put your faith in the doctor and the companies that make these products because they're the experts," Korgaokar said. "It's just beyond me to think that things can get approved that really don't work. It leaves me speechless."

A U.S. Senate Special Committee on Aging will Wednesday hold a hearing to examine the Food and Drug Administration's medical device approval process. Korgaokar will testify alongside six medical device experts.

Investigations by FDA officials and outside researchers have revealed troubling lapses that have led to device recalls -- sometimes requiring surgery.

A February study published in the Archives of Internal Medicine suggested most medical devices recalled for life-threatening or serious hazards were cleared by the FDA through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely.

"In my view, the regulatory system is failing," said Dr. Steven Nissen, a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen and colleagues examined the number of medical device recalls from 2005 to 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous pre-market approval process. Of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k), and eight were exempt from FDA regulation.

"Some 80 percent or so of devices being recalled were actually never fully clinically tested in people," Nissen said.

Copyright 2011 ABC News Radio

Wednesday
Mar022011

Actor Mickey Rooney to Take Stand Against Elder Abuse

Photo Courtesy - Jeff Kravitz/ FilmMagic/Getty Images(WASHINGTON) -- Actor Mickey Rooney is scheduled to speak out against elder abuse before a Senate committee on aging Wednesday.

The 90-year-old actor has been the alleged victim of abuse at the hands of his own stepchildren, according to court documents.

Rooney, who has had one of the longest careers of any actor, was recently granted court protection from stepson Chris Aber and his stepdaughter Christina Aber, after he filed a case against them charging verbal, emotional, and financial abuse, and alleging that they denied him such basic necessities as food and medicine.

"All I want to do is live a peaceful life, to regain my life and be happy," Rooney said in a statement to his fans.  "I pray to God each day to protect us, help us endure and guide those other senior citizens who are also suffering."

The goal of the Senate hearing, entitled "Justice for All: Ending Elder Abuse, Neglect and Financial Exploitation," is to draw attention to the widely underreported problem and coordinate federal, state and local efforts to combat it.

"It's a really sad but important issue and Mr. Rooney is definitely lending his star power to it," committee spokesman Joe Bonfiglio said.

According to court documents, Chris and Christina Aber allegedly kept Rooney as "effectively a prisoner in his own home" through threats, intimidation and harassment.  Christina Aber has also been accused of taking control over Rooney's finances, blocking access to his mail, and forcing the actor into performances he does not wish to do.

Rooney was granted temporary restraining orders on Feb. 15, but will have to appear in court on April 5 if he wants them extended for three years.  A Los Angeles Superior Court Judge also appointed a temporary conservator of Rooney's estate.

While elder abuse of this magnitude is relatively rare, geriatric experts say instances of some kind of abuse and neglect -- whether psychological, physical, sexual or financial -- are a major concern among aging populations.  According to the American Psychological Association, an estimated 2.1 million older Americans become victims somewhere on the spectrum of abuse.

Copyright 2011 ABC News Radio







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