If we are to truly set our sights on the goal of reforming health care, we need to begin with the FDA. The FDA allows pharmaceutical companies to apply for and gain approval of permanently implanted medical devices, (specifically surgical mesh products) under the 510K approval process. Under this process, clinical trials are not required.    A manufacturer simply has to show their device is substantially equivalent to a device already on the market, and approval is granted - usually within 90 days.  The FDA is treating some permanently implanted devices as if they were band aids - a quick fix. These devices can adhere to organs and/or nerve beds, erode through the vaginal epithelium, and are sometimes rejected by the body. These conditions may cause the individual near-constant pain.  In some instances, they have even caused death.

When faulty devices are approved by the FDA, it costs hundreds of thousands, perhaps millions of dollars for revision surgeries. Insurance companies are paying for multiple revisions and consumers are picking up the out-of-pocket expenses for injuries sustained from these products.

After being injured by a mesh product, I spent a year and a half researching not only the specific surgical mesh device that was implanted in me, but several additional brands of surgical mesh. The common denominator I discovered is that is each of the devices was either directly or indirectly related to the ProteGen Sling. The ProteGen Sling was manufactured by Boston Scientific who voluntarily recalled their device from the market on January 22, 1999. The FDA formally recalled this product in their March 17, 1999-enforcement report, and the reason stated was:

“Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.”

Despite the fact that Boston Scientific voluntarily pulled their device from the market,  the FDA knowingly chose to leave other devices that had used this faulty device as their substantial equivalent to remain on the market.  These devices have subsequently been used for newer mesh products to gain FDA approval.  The FDA is allowing citizens of the United States and many other nations to become injured by devices they know cause serious injuries.  It is shameful.

Every time we turn on the television, we are inundated with one of two things:
    a.)    Advertisements  for new medications that list side effects that range from swelling of the tongue to suicidal tendencies
    b.)    Medications that have been recalled ranging from injury to a fetus to death.

The United States is only one of two countries that allow pharmaceutical companies to run ads on T.V.  In doing so, they are promoting self diagnosis by the consumer, as opposed to being diagnosed by a legitimate doctor.

In an article written by Mike Ferrara on March 19, 2009 for the Injury Board, it was disclosed that “Massachusetts officials approved strict regulations prohibiting pharmaceutical and medical device companies from offering gifts to doctors, limiting the circumstances under which they can pay for doctors’ meals, and requiring them to publicly disclose doctor payments over $50 for certain consulting and speaking gigs.”  It was also disclosed that Massachusetts is the only state that has passed such stringent laws in regards to these types of kick backs, and for that I applaud them.  This should be the standard in every state, not the exception to the rule.  In implimenting such policy, it would cut back on doctors unnecessarily prescribing new, harmful drugs or pushing untested medical devices on their patients.  This would reduce medical costs.

There was a time when one could trust their doctor and know that the recommendations he or she  made were almost implicitly in the best interest of the patient, but in this new era of mega-profit, it seems the hippocratic oath has flown out the window.

We must do away with the pharmaceutical lobbyist and get the pharmaceutical companies, the FDA, the doctors and our elected officials out of bed with each other.  Until regulatory agencies in the United States can recognize and rectify these problems, we as a society are doomed to poor, exorbitantly priced healthcare.