The market for the manufacturing of medical devices has more than doubled since the year 2000, with industry sales topping off at around $400 Billion. Unfortunately, federal oversight has lagged behind, and the consequences have been devastating. Worldwide, more than 2 million people have been injured by medical devices, and around 80,000 have been killed.
On Sunday, the New York Times editorial board called for a “reckoning” on medical device safety.
The scathing op-ed begins with the tragic story of pelvic mesh, a medical device approved by the Food and Drug Administration (FDA) with scant clinical data showing it was safe and effective. After coming on the market, pelvic mesh hurt thousands of women, leaving many of them permanently injured.
Nearly 80 American women were killed.
The FDA finally prohibited the sale of pelvic mesh in March. Why? Because a panel of experts looked at the data and agreed that using pelvic mesh was no better for most women than not using it — in short, it was found to be ineffective. The painful experiences of thousands of women demonstrated clearly the device’s lack of safety. And at long last, an unsafe, ineffective device was removed from the market.
How Do Dangerous Devices Get FDA Approval?
Sadly, pelvic mesh is far from the only product to hurt consumers in ways they were never warned about. Each year, medical devices without any clinical research are cleared to enter the market by the FDA. “It seems incredible,” wrote the New York Times:
“that products meant to reside inside the human body would be used on patients without any proof of safety or efficacy. But thanks to regulatory loopholes and lax oversight, most medical devices are poorly vetted before their release into the marketplace and poorly monitored after the fact.”
The FDA is a powerful agency with a unique opportunity to exert pressure on companies to make sure that their products are safe. People around the world rely on the agency’s expertise and judgment, but because of the way that medical devices are approved, the FDA essentially punts on its responsibility to consumers to demand evidence of safety and efficacy.
What Changes Can the FDA Make to Better Protect Consumers and Patients?
The Times editors listed several adjustments they believe will help the FDA recover its footing, reestablish itself, and improve the current system.
This begins with fixing a regulatory loophole known as the 510(k) pathway. Companies are able to use this pathway to get their device approved without clinical research so long as the device is “substantially equivalent” to a device that is already cleared for the market. All pelvic mesh was approved this way, as were all metal-on-metal hip implants.
The federal agency also needs to address how it handles post-market surveillance. After a medical device reaches the market, companies are required to conduct research to make sure that the device is working as planned. Yet companies often don’t complete this research, and when they do, they have ways of burying evidence of harm caused by medical devices.
The FDA has promised to end these secretive databases and to get all relevant data on adverse medical device events out into the open. In March, however, the FDA sent warning letters to 2 manufacturers of textured breast implants — the type linked to a rare form of cancer — because they had failed to conduct adequate post-market research.
These steps towards transparency may have an impact, or they may be quickly countered by industry lobbying. The final task for the FDA, according to The New York Times editors, is to “loosen [the] industry’s grip.”
More than 35% of the agency’s funding comes from the medical device industry, and this particular industry wants approval fast. In fact, they rely on it. The medical device lobby spends enormous amounts of money to get regulations tilted in their favor. So far, the FDA has complied, and millions of consumers have paid the price.
Regulators Should Be a Patient’s First Line of Defense
Most manufacturers pulled their pelvic mesh products long before the FDA officially halted sales and distribution. In large part, this was because companies have paid out $8 Billion in damages in pelvic mesh lawsuits.
In other words, it was pressure from the civil justice system — not federal regulators — that forced these medical device companies to think about women’s health, long-term side effects, and unintended consequences.
And that’s the problem. American consumers do not believe that the FDA can prevent every accident or foretell the future, but they do expect the agency to base its approval for surgical implants on strong clinical evidence.
If the FDA gets rid of loopholes and enforces its own regulatory laws, it won’t be convenient for companies that are trying to rush medical devices to market. They will cry out that “Big Government” is standing in the way of progress.
Let them cry, and let the FDA do its job of keeping people safe.
