FDA Hearing to Focus on Metal-on-Metal Hip Safety Issues

The US Food and Drug Administration will commence two days of hearings on issues relating to the safety and effectiveness of metal-on-metal hip replacement devices. The hearings come in the wake of numerous metal-on-metal hip replacement lawsuits that allege the medical devices suffer from faulty design and may lead to a serious medical condition known as metalosis where the metal parts of the replacement hip grind against each other and metal debris enter the bloodstream leading to metal poisoning.
According to an article in today’s NY Times, “Why were these devices implanted in 500,000 people without adequate testing?
“There was not enough data to support” their widespread use, said Dr. Henrik Malchau, an orthopedic surgeon at Massachusetts General Hospital in Boston.
Under F.D.A. rules, orthopedic implant makers did not have to run clinical trials of the hips before marketing them, nor were they required to follow patients afterward to see how they fared. Doctors embraced the implants without evidence they were better or more durable than existing ones.
Many doctors say they adopted the devices believing they would help reduce a complication of hip replacement — the possibility of implant dislocation.”
In May 2011, the FDA ordered five hip replacement makers to conduct studies on how patients who’d received the metal-on-metal hips were doing. Thus far, only the Biomet study plan has been accepted by the FDA. The federal agency has rejected plans from DePuy, a division of Johnson & Johnson as well as Zimmer, both of whom are considered leaders in the hip replacement industry.