Is a Medical Device Safe If It Is FDA Approved?

Medical devices have the potential to change lives, which is why millions of Americans rely on the medical products offered by manufacturers every year. These promises are monitored by the Food and Drug Administration, the regulatory body in charge of verifying claims made by medical device producers. However, is FDA approval enough to guarantee that a medical device won’t end up harming the person it was supposed to help?

When FDA Approval Doesn’t Matter

Jim Taft is mostly confined to his bed because of an attempt to relieve severe arm pain. After undergoing surgery to install a device called a spinal-cord stimulator, Jim discovered that his arm pain was the least of his worries. After surgery, the stimulator malfunctioned, and Jim needed the device repaired with yet another surgery. Afterwards, his spinal-cord simulator wouldn’t stop shocking him—his means of pain relief was impeding his ability to function. Jim Taft has suffered falls, has trouble sleeping, and can hardly accomplish basic tasks on his own because of the malfunctioning device.

Taft is a part of the growing number of Americans discovering that some medical devices don’t live up to manufacturers' promises despite being FDA approved. An Associated Press investigation found that the FDA has received over 80,000 incident flags since 2008 regarding these devices. They are the third most common medical device incident report in the nation. Data from the FDA reveals that these devices are associated with reports of over 500 people dying.

Despite reports of death, burns, and electrical shock, manufacturers stand by the safety of their spinal-cord stimulators—about 60,000 patients continue to receive them annually.

The Abbreviated Approval Process: Unreliable & Potentially Deadly

Medical devices are regulated with weaker standards than those used for drugs because different laws govern each. The Medical Device Amendments of 1976 was supposed to spark innovation by fast-tracking device approval. Today, weaknesses with the law enable corporations to receive FDA approval for their devices in a way that allows oversight to happen.

When a drug needs FDA approval, it undergoes a much more rigorous process. When a drug causes problems for patients, the FDA has the power to remove it from shelves. For medical devices, the process is inverted: devices can receive fast approval, but it can take a long time for the FDA to recall a defective one. The administration doesn’t release information regarding how many devices are implanted throughout the United States annually, so advocacy groups can't collect accurate failure rates for troubled devices.

Adding to the frustration of the FDA’s medical device safety system is the fact that the administration acknowledges weaknesses with its methods. Despite admitting to mistakes, under-reporting, and omissions, the FDA denies its system is prone to failure.

“There are over 190,000 different devices on the U.S. market. We approve or clear about a dozen new or modified devices every single business day,” Dr. Jeffrey Shuren, the FDA’s medical device director, said at a 2018 conference. “The few devices that get attention at any time in the press is fewer than the devices we may put on the market in a single business day. That to me doesn’t say that the system is failing. It’s remarkable that the system is working as it does.”

The Allergan Breast Implant Recall: Showing Cracks in the FDA’s Medical Device System

In 2017, the FDA released a warning about Allergan textured breast implants. The administration announced that it suspected the implants were connected to cases of implant-associated anaplastic large cell lymphoma. By 2019, 38 countries ordered a recall of the Allergan-produced implants. However, the FDA remained reluctant to make an official recall as it continued investigating the implants.

By the time that the FDA suggested a recall in July of 2019, the medical community had connected 481 cases of BIA-ALCL to the implants. At the time, there were 573 worldwide cases of this rare cancer. In other words, 83 percent of one type of cancer’s cases involved Allergan textured implants. The FDA didn’t order the recall; it only suggested that a recall was "advisable" to Allergan. The final number of patients who developed cancer because of Allergan textured breast implants has yet to be determined.

When Medical Companies & the FDA Don't Make Things Right, Clayton, Frugé & Ward Does

Clayton, Frugé & Ward has been a proud advocate for clients since 1991. If you’re suffering because of a defective medical device, our firm is ready to fight for the answers you deserve. Our law firm has a history of victories for clients that reveals one thing: no company is too big for us to take on, and no case is too complicated for us to handle.

If you’re suffering because of an FDA-approved medical device, call Clayton, Frugé & Ward today at (225) 209-9943. Our team is ready to find the answers that you deserve.