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.
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.
Senator Blumenthal's legislation is sorely 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 actually 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.