The battle over medical device regulation is heating up with the reauthorization of the Medical Device User Fee Act.
At stake is whether medical devices that are put in your body -- cardiac stents, heart valves, knee and hip implants, among others -- will be subject to safety tests in humans before they are approved by the FDA.
Katherine Korgaokar was shocked when she found out that she was one of tens of thousands of people who had an artificial hip implanted that had never been tested in humans.
In testimony on Capitol Hill, she described how the implant was recalled because of design defects. Excessive wear and tear caused bits of debris from the metal implant to break off. A blood test found excessive levels of toxic cobalt and chromium, which were used to manufacture the joint. She needed a second surgery that was more painful than the first, and recovery was a lot longer, too.
"It is amazing to me that something that doesn't work properly gets approved," Katherine said when she was interviewed on ABC Nightly News.
A flurry of bills have been introduced in Congress by medical device industry supporters to speed up FDA approval of medical devices rather than ensure they are tested before they are sold. Enthusiastic members of Congress say that this will create jobs.
Congressman Erik Paulsen, a Republican from Minnesota, supports the legislation and says it will "ensure we keep and expand jobs here in our communities."
Congressman Adam Kinzinger, a Republican from Illinois, claims that industry-favored legislation will ensure that the FDA review process will "eliminate the threat of sending these good paying jobs overseas."
In a country starved for employment, playing the jobs card in the medical device battle makes for a catchy sound bite. Here are the jobs they will create:
Assume 10,000 Americans have to have a second hip surgery to remove a defective hip implant and replace it with a safer, more reliable model.
This creates employment for doctors. If an orthopedic surgeon performs two hip replacements a day for 20 days each month, 20 surgeons will be fully employed for about a year. Nurses in the operating rooms, recovery rooms and surgery floors will be employed.
Drug companies will employ people to keep producing the pain drugs that people will need to manage their physical suffering.
Johnson & Johnson will sell more bandages, sutures, and other materials used during the surgery.
The American Hospital Association will be pleased that its member hospitals will have an additional 10,000 patients that year admitted to their facilities. A certain percentage of them will surely be readmitted because they will get an infection while in the hospital.
Meanwhile, device companies will churn out another 10,000 replacement joints. Maybe they will be made in the good old USA. Or maybe not. Big device companies are following the money. Medtronic, based in Paulsen's home state of Minnesota, announced it is hiring a thousand people in China.
Lawyers for patients and the device makers will be employed for years handling rightful demands from people for compensation.
The unemployed will take the jobs of those who needed repeat surgery and can't go back to work right away, if ever.
Sound familiar? This type of job creation mimics the job creation in the sub-prime mortgage meltdown. Banks gave mortgages to people that were sure to blow up in their faces. Yet those sub-prime mortgages created jobs in construction, real estate and banking. Then the whole scheme came crashing down. Innocent bystanders were merely collateral damage.
This was no way to run a banking system. Neither is it a way to run a health care system.
The Consumer Union Safe Patient Project says that on average 700 different medical devices are recalled each year, and in 2009, the FDA received reports of nearly 5000 deaths associated with medical devices.
What should be done? Implantable and life-sustaining devices should be tested in real people before they are approved.
Rosemary Gibson is author of The Treatment Trap: How the Overuse of Medical Care is Wrecking Your Health .
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