FDA Issues Statement About Unsafe Medical Device Materials

About a week ago, the FDA announced that in the future it would be looking more closely at a range of medical devices and products — along with the materials they’re made from — that have caused the most trouble for consumers in recent years.

In its statement, the FDA singled out breast implants, metal-on-metal hip replacement systems, and the components of birth control implant system Essure. Most strikingly, the announcement targeted not just the final products manufactured by medical device companies, but the materials they used to make the products.

Materials in Unsafe Medical Implants Are the Real Problem

This should come as no surprise to anyone who has been following the latest in unsafe medical device lawsuits, since in the case of all of the products identified as problematic by the FDA, it was not the systems themselves but their constituent materials that ultimately harmed patients. In the case of breast implants, it was silicone. In the case of the Essure permanent birth control implant system, it was nitinol. And in the case of metal-on-metal hip implants, it was the heavy metals used in the implants that poisoned patients internally through a condition called “metallosis.”

Implant Industry Does Its Own Safety Tests

Because, in the case of implantable or insertable devices, materials come into contact with tissue or other parts of the body for sometimes extended periods of time, we do a careful evaluation during our premarket review to determine if there is a potential adverse biological response resulting from contact of the device’s component materials with the body and whether the associated risks are unacceptable.
— FDA

While the FDA is late to this party, it is a relief to see that the regulatory agency has at least recognized that more oversight of the manufacturers of implant technologies is needed. Moreover, it is good to see that the FDA is prepared to look more closely at the materials of which the devices are composed, since these have proved to be the most problematic elements of late.

As the devices and their materials become more complicated and exotic, they must not only be better regulated, but a more stringent testing process woudl seem to be in order. Currently, and rather shockingly, the manufacturers of implant technologies are permitted to test their own products; there is no independent review process. The FDA only steps in after a problem has been identified and pressures the manufacturers to issue a recall.

PA & NJ Unsafe Medical Device Law Firm

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If you or someone you know has been the victim of an unsafe medical device or implant, please contact our attorneys immediately for a free consultation at 2215 462 3330 or by using our online contact form.

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