Consumer Reports is taking aim at implants today, maintaining that many of them, including gastric Lap-Bands and transvaginal meshes, have never been tested for safety.
The consumer-focused magazine doesn't mince words, calling the regulatory system broken and putting patients at risk. In fact, "the only safety 'testing' that occurs is in the bodies of unsuspecting patients," it charges. In addition to the Lap-Bands and meshes, the magazine looks at metal hips and cardiac devices.
In the case of Lap-Bands, the magazine trots out results from the lone study Allergan ($AGN) needed to submit to obtain a regulatory sign-off in the U.S. Of the 299 enrollees, 25% had their bands removed before the end of the three-year study because of complications or failure to lose enough weight.
"Imagine if a car had a recall rate that high," explains John Santa, director of the Consumer Reports Health Ratings Center, as quoted by the magazine. "Consumers and regulators would be up in arms. But in the world of medical devices, these things often stay hidden."
Allergan, of course, disagrees with this contention. The Lap-Band "has been approved internationally since 1993, and as such has a 19-year safety and effectiveness record," company spokeswoman Naziah Lasi-Tejani asserts, as quoted by the Los Angeles Times.
The magazine also chastises the current system for not having a better alert mechanism to quickly detect problems with devices. Last year, the FDA asked 20 devicemakers to investigate whether their hip implants raise the level of metal in patients' blood to dangerous levels. That request came not long after DePuy's recall of all 93,000 ASR XL hips implanted worldwide. Still, officials in Australia, England and Wales had started noticing problems three years before the recall. "They were able to do so because they have national joint registries ... and the ability to track how patients fare with various models. There is no such national registry in the U.S., although Kaiser Permanente has a large private one," the magazine notes.
Furthermore, many products have been grandfathered into the system as substantially equivalent to an existing product without additional testing, as was the case with transvaginal meshes. After numerous women were injured, the FDA called on manufacturers to do post-market studies, the magazine notes.
"The paradox is that companies go to the FDA and claim that a device is 'substantially equivalent,' but when they market it, they claim it's 'new and better,' " says professor Rita Redberg of the University of California, San Francisco. Plus, the clearance process costs manufacturers little; they pay the FDA a user fee of $4,049, according to the magazine.
Consumer Reports has some ideas on how to improve the system, however:
• Require that implants and other "life-sustaining" devices be tested at least as rigorously as drugs;
• End the practice of "grandfathering" high-risk new implants and life-sustaining devices;
• Create a "unique identifier system" for implants, so that patients can be quickly notified about recalls and safety problems;
• Create national registries so that problems can be spotted quickly and patients notified; and
• Increase user fees paid by manufacturers for regulatory review so that the FDA has enough money to do its job.