Calling for change in FDA medical device approval
“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.