The Food and Drug Administration strictly regulates medications that are prescribed in the United States, requiring proof of safety and efficacy before they can be given to patients.

It can take up to 10 years from the initial discovery of a pharmaceutical product to full approval for its sale to the public. Some people want to speed up the process, worrying that people might die while waiting for medication to be approved.

The exact opposite happens with medical devices. In as little as six months, a device can be marketed to the public for use for a variety of medical conditions, with virtually no safety or efficacy testing done.

Faulty medical devices such as implants can lead to repeat surgeries for patients.

Jeff Kubina/

How can the public expect to be safe with this lack of oversight for devices that could be implanted or used to treat serious medical conditions?

This year alone has seen over 30 medical device recalls, including malfunctions such as the risk of inaccurate testing for blood thinners, cardiac devices failing at altitude, and electrical conduction of wires malfunctioning while in use in the human body.

Could closer regulation from the FDA help to prevent the estimated 80,000 deaths from medical device failures and 1.7 million injuries that have happened in the U.S. since 2008?

It only make sense that the medical community do more testing on medical devices, especially in emerging fields like biologics and regenerative medicine.

The FDA has committed to reviewing the process of regulation. Currently if a particular device such as a hip replacement was previously approved for use, then newer devices used as hip replacements are approved through a streamlined process. This is based on the fact that the device is being used for the same reason as the prior approved device. But in recent years, newer metals have been used and some have failed while in use, requiring repeat surgical procedures for elderly patients.

In other cases, metals have leaked into the bloodstream, requiring yearly monitoring.

In November,  FDA Commissioner Scott Gottlieb suggested requiring new data on any device that is based on a similar model that is more than 10 years old. But with the pace of technology, that timeline is not enough.

Ten years ago, smartphones were just starting to be popular, and apps had yet to go mainstream. Many people still used flip phones.

It only make sense that the medical community do more testing on medical devices, especially in emerging fields like biologics and regenerative medicine.

Correction: An earlier version of this column mistakenly said that Essure was made by Johnson & Johnson.

Although manufacturers are required to report on potential problems with their products, as seen in the controversial Essure birth control recall by Bayer, patients often have to take things into their own hands and form support groups of their own to advocate on their behalf. The Netflix movie “The Bleeding Edge” told the story of the medical device approval loopholes in the U.S.

Other countries rely on Europe and the U.S. to handle regulations designed to avoid having dangerous products on the market. Now the International Consortium of Investigative Journalists has banded together to create the “Implant Files,” a worldwide review of medical devices that have reportedly caused medical harm in patients.

Here in the U.S., it is the responsibility of the FDA to change its outdated rules of pre-market approval. Unlike a medication that often can be easily stopped, implanted medical devices are not easily removed.

We need it get it right the first time.

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