U.S. Sen. Richard Blumenthal has joined two other senators introducing legislation designed to protect patients from unsafe medical devices without derailing the current fast-tracking system of medical device approvals.
Called the Medical Device Patient Safety Act, the proposal would mandate that the Food and Drug Administration (FDA) track recalled medical devices and better manage recalls when problems occur, said Blumenthal, a Democrat.
“Patients will be better protected,” Blumenthal said Wednesday. “This idea is common sense and it fixes a badly broken system.”
Under the current system of bringing new medical devices to market, “96 percent are fast-tracked with virtually no clinical testing” if they are considered a modification of an existing medical device, Blumenthal said.
Faulty medical devices such as metal-on-metal hip implants, knee replacements and defibrillators have been subject to worldwide recalls, he said. When they fail, patients are left with debilitating pain, leakage of toxic chemicals causing antibiotic-resistant infections and a variety of serious health effects, he said.
“Strong action is needed to stop defective medical devices from causing widespread, horrific injury and death and dramatically raising health care costs,” he said. “Thousands of faulty, dangerous devices are in use and implanted in patients because the current FDA system of oversight and surveillance is badly broken. Our commonsense, bipartisan reforms improve patient protection by empowering the FDA to conduct better recalls and stronger oversight and surveillance after a device becomes available.”
Under the proposed bill, post-market consumer safeguards would be mandatory so that problems would have to be reported to the FDA and faulty products recalled more quickly. The proposed legislation “gives real teeth” to the oversight process, he said.
Carolyn Sires, 49, a physical therapist and owner of Physicians Physical Therapy in West Haven, attended Blumenthal’s press conference to support the proposed legislation because of her experience with a faulty hip implant, saying, “I have been a testing mechanism for this product.”
After researching products and selecting one that she described as the best for active people, Sires, then 45, had her hip replaced with a metal-on-metal device in 2008. For a year afterward, she experienced fevers, infections, the inability to walk and a host of other ailments. She visited multiple doctors and underwent a battery of tests. Her doctors didn’t realize her body was reacting to the metal-on-metal hip because they were unaware of other patients having similar problems from their new hips, she said.
The hip was recalled a year later, and when she had surgery to have it removed in 2009, her doctor said her muscles had been shredded. She has since had a third hip replacement, suffers chronic pain, takes multiple medications to fight infection, has to have fluid drained from her body every three months and, at 49, has been told she has the choice between her current condition or spending the rest of her life in a wheelchair.
Health advocates urged Congress to support the legislation. The Government Accountability Office estimates that some 700 medical devices are recalled each year, said Charles Bell, program director with Consumers Union. “Unlike drugs, where people can stop taking them if they experience adverse reactions, some medical devices are implanted and may need to be surgically removed,” he said. “This bill will help the FDA to get unsafe devices out of the market more quickly and improve tracking and recall procedures.”
This legislation is needed, said Jean Rexford, executive director of the Connecticut Center for Patient Safety. “I think we might be doing a better job of monitoring what we’re putting in cars than what we’re putting in people,” she said, decrying the practice of putting 96 percent of new medical devices into the market without testing if they are substantially similar to existing products. There are currently no legal requirements for surgeons to notify anyone if their patients have an adverse reaction to a medical device, added Rexford.
In December 2010, C-HIT reported that DePuy Orthopaedics, a medical device manufacturer and a division of Johnson & Johnson, had come under fire with its worldwide recall of a hip implant device known as Acetabular ASR LX, which was used on 37,000 patients in the U.S., some from Connecticut.
U.S. Sens. Chuck Grassley (R-IO) and Herb Kohl (D-WI) co-sponsored the legislation.
I would have thought that the FDA had better oversight over medical devices. It seems like they have a great system for drugs. I would think that anything that goes into us, whether it is a metal hip replacement or medicine, that the FDA would have strict oversight.