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Regulatory control of medical device industry spotlighted

A recent Consumer Affairs article makes the central assertion that the medical device industry has been comparatively untouched by regulatory oversight and exactions over the years. The piece states that the realm “has mostly avoided the type of scrutiny that drug companies and health insurers sometimes face.”

A wide swath of the general public might agree with that.

As for industry participants themselves … not so much.

In fact, device makers might reasonably respond to that claim by pointing to empirical evidence showing a veritable mountain of rules and regulations closely affecting their businesses. Medical devices typically take many years to get to market, being first required to pass myriad regulatory tests. Clinical trials are a commonplace. Elected officials and multiple health care organizations often play a role en route to a device’s eventual approval or rejection.

And there is this reality, too, which is noted repeatedly and well understood by device manufacturers: If they are receiving widespread media attention, it’s likely because of a negative story line relevant to a product.

Take Bayer, for instance, which is the spotlighted subject in the above-cited article. Attention is now centrally fixed upon its permanent birth control implant Essure. That device was approved by the FDA nearly a generation ago and continues to receive doctor endorsements, including from the American College of Obstetricians and Gynecologists.

Candidly, though, Essure also invites criticisms, levied by many women and various groups contending that it never received proper regulatory scrutiny and has harmed high numbers of users. A recent documentary tracks the product’s history and argues that the device manufacturing industry suffers from inadequate regulation. Bayer recently decided to discontinue Essure sales in the U.S. by 2019.

News surrounding Essure and the medical device realm generally is recurrent and fast moving these days. We will be sure to timely report relevant details to our readers in New York and elsewhere.

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