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Michael Monheit
Michael Monheit
Attorney • (215) 840-6573

From hippies to hip replacement surgery

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Those were the days my friends, we thought they’d never end. Hey boomers, you rocked and you rolled and now you’re rolling a walker because of hip replacement surgery and hip implant surgery.

Who can believe it? As a generational group, you were the healthiest and wealthiest generation to that time, and among the first to grow up genuinely expecting the world to improve with time.

If you grew up immersed in those values, how do you feel today knowing that hip implant failure happens to too many people because of their trust in hip implant makers, their doctors, and the FDA?

Why?

Section 510(k) of the Food, Drug and Cosmetic Act requires hip implant device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k).

This process allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Medical hip implant device manufacturers are required to submit a premarket notification if they intend to introduce a device for commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use

In other words hip implants by different manufacturers with different names that all do more or less the same thing and serve the same purpose go into the medical marketplace without clinical trials.

Hence, pending hip implant failure or boomers and beyond as guinea pigs.

If you are no longer dancing in the street and have had the rug pulled out from under your robust quality of life because of hip replacement surgery and hip implant failure – by all means contact a hip replacement lawyer to find out what your legal options are.