Calling for change in FDA medical device approval

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“When our FDA approves a device, every country in the world looks at it and says that must be safe, but it’s not so,” says Dr. Hooman Noorchashm, a cardiothoracic surgeon.   He says Congress is failing to protect people’s lives with legislation called 510(k), which is a 1976 amendment to the Food, Drug and Cosmetics Act.   It puts FDA approval on a medical device with relative ease, as long as it’s somewhat similar to other products already on the market.

“This is not a small thing. There are thousands of patients going into hospitals every day and are subjected to medical devices that are not safety tested,” Noorchashm said.

Power morcellators are used during laparoscopic hysterectomies to cut up tissue so that it can be extracted through a small incision.  The FDA approved the first one in 1991, and since then has put its stamp on similar devices through the 510(k) process.  Some doctors argue that the smaller opening offers patients fewer complications and less recovery time.  However, this wasn't the case for Noochashm's wife Amy Reed, who is also a physician.  Doctors used a morcellator on her during her hysterectomy surgery last year, and she says the device spread undetected cancer all over the inside of her abdominal cavity.    "That's how cancer works.  Of course if you chop it up, it spreads," she said.

After concerns were brought to Congress over 510(k)'s safety, the FDA in 2009 paid the Institute of Medicine (IOM) 3.5 million dollars to conduct a 2 year review of the rapid-approval process.  Dr. David Challoner chaired the review committee and testified before Congress in 2011 saying, "We came to the conclusion that the 510k process as outlined in law generally does not evaluate the safety and effectiveness of a device, only the new devices' similarity to a predicate."   Dr. Challoner says his expert testimony was received and forgotten and nothing was done to fix the problem.  "The inertia that the Congress has had in taking any action to move forward, even to study it more, is unacceptable,"  Challoner said.

Noochashm agrees.  "What you will see is that the United States Senators stepped completely away from the concept of patient safety and ignored the recommendation of the Institute of Medicine.  It's a very clear demonstration that our Congress is incapable of acting in the best interest of our people," he said.

When asked about 510(k), Senator Bob Casey said that there were no plans to bring the legislation up again anytime soon.


  • NRajamannan

    This story highlights the critical safety issues related to the 510k process. Fox News Chicago ran a story which demonstrates that patients not only received an investigational device that eventually got 510k approval 2 years after the initial testing, the FDA has not informed the 667 patients of the investigational status of the model 5100 annuloplasty ring to date.

  • NRajamannan

    The model 5100 was placed under a voluntary recall from Oct 2008 to April 2009. The FDA to date have not informed the patients of the recall to allows physicians to assess the potential risks and adverse events related to this device.

  • explanthis

    In 2010 I was flown to DC/FDA for a workshop for Patient Representatives. I learned then that my job would be to convince Congress to change the antiquated 1976 CDRH charter of the FDA that allows this PREVENTABLE harm to continue. Meanwhile there are 64,000+ harmed patients in MDL(multi district litigation) for implanted pelvic surgical mesh, thousands harmed by metal-on-metal hips and nearly 14,000 Bayer Essure harmed women who are facing hysterectomy to remove the coils that were to be a non-surgical, affordable, permanent birth control. Congress is not relevant. FDA is not relevant. The public and consumers deserve to know that they are not protected by their elected officials and bureaucrats/government employees. The judicial system is a poor bandaid for this kind of individual human misery and national financial hemorrhaging.

    • NRajamannan

      2009 I met with the FDA 3 times to review the investigational use of the model 5100 in patients without informed consent and prior to the 510k process.

      To this date, the FDA has written one patient that I know of regarding the investigational nature of the device, and has asked Congress to contact the patient. The letter went out on July 16, 2009 and to this date, the patient has not been contacted again.

  • ChasmPrecipiKARL

    The factories where the medical instruments are made are so afraid they will be sued by the workers that are supporting management, temporary referral agencies,etc…

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