Inexpensive Medical Device Approval Requires Frank Disclosures

Johnson & Johnson knew about at least some of the serious problems related to their DePuy ASR hip implant, known as metal-on-metal (MOM) implants,  before they ever started alerting consumers and it appears they may have known about it even before they asked the FDA to approve the device through a “quickie” process known as a “510(k)” submission.

We have published a number of articles in connection with the value and dangers associated with the Food & Drug Administration’s “510k” approval process for medical devices. This process allows medical device manufacturers to move devices out to consumers more rapidly and without any significant testing. This is done through a process in which the manufacturer must justify that their current device is substantially similar to other devices already approved and already on the market.

In essence the 510(k) approval process is the ultimate short cut for manufacturers to sell medical devices to consumers. Like any short cut, the methods used to reach justification for using this abbreviated process must rely heavily on honest and full disclosure on the part of device manufacturers.

An August 13, 2009 FDA letter to DePuy Orthopedics (Johnson & Johnson), the Food & Drug Administration evaluators suggested that the manufacturer had changed study parameters and evaluation criteria in order to produce results that substantiated safety of the device; rather than simply evaluating the results for what they represented. The letter also set forth 13 pages of criticisms and deficiencies the FDA had with the various studies and rsearch used in justifying approval of the MOM devices.

One of the very concerning results of metal-on-metal implants like DePuy’s is the release of metal ions into the patient’s body, caused by the friction of the metal against metal within the joint. These ions are characterized as being heavy metal such as cobalt and chromium. They have been connected with a number of potential health conditions, including:

• Increased erosion of healthy bone
• Pseudotumors
• Inflammatory syndromes
• Liver or kidney damage
• Vision or hearing loss
• Cardiomyopathy (weakening of the heart muscle)
• Cognitive impairment
• Hypothyroidism
• Peripheral neuropathy (nerve damage)
• Rashes
• Shortness of breath

If you have had a MOM (metal-on-metal) hip implant and begin developing any of these conditions or symptoms of them, you should immediately contact your physician.