The Government Accountability Office testified last week before the Senate that the Food and Drug Administration has continued to approve dozens of high-risk medical devices like artificial hips although the devices may need to undergo more strenuous testing before being sold. The group says that selling the devices without more testing could be exposing patients to risks.
Johnson & Johnson’s now-recalled artificial hip known as the A.S.R., or Articular Surface Replacement is one of the products expected to be reviewed by the Senate. The company continued to sell the hip despite repeated reports from physicians that the device was faulty. Johnson & Johnson was allowed by the FDA to market and sell the artificial hip without conducting clinical trials. A few years after implant, it began disintegrating in patients, shedding metallic debris that has left some patients crippled. Reports issued by doctors in England indicated the device may fail prematurely in about 50 percent of the patients receiving it.
Currently, the FDA uses two different procedures to approve medical devices. Manufacturers of devices that pose a lower level of risk to patients are only required to show that a new product is substantially equivalent to one already on the market. Clinical trials are only necessary to win approval for more critical devices, like implanted heart defibrillators.
The FDA’s device approval process is currently being reviewed by the Institute of Medicine. A report is expected to be released later this year.
The attorneys at Messa & Associates are experienced at handling cases involving pharmaceutical and medical device injuries. Our extremely skilled team of attorneys and medical experts are dedicated to ensuring your receive proper compensation for your injuries. For more information or if you have been seriously injured by a defective medical device, please contact us at 1-877-MessaLaw.
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