The Bleeding Edge

This eye-opening look at the fast-growing medical device industry reveals how the rush to innovate can lead to devastating consequences for patients.

In 1976, the Medical Device Regulation Act, also known as Medical Device Amendments, ushered in the modern method of medical device regulation. The Bleeding Edge outlines the current system and shows how the outdated process doesn't work well for medical device regulation.

In the film, it's suggested that manufacturers have an influence on the outcome or perception of the trials. The film illustrates this with the case of Essure by interviewing women who were a part of the clinical trial. They stated that their reported experiences with the permanent birth control device had been altered in the trial results, making the device appear safer than it is.

The way money is transferred between medical device manufacturers, lobbying groups like AvMed, and physicians is brought to light in the film, highlighting a number of questionable allowances within the industry. Some opinions expressed in the film indicate the FDA, captured by industry, isn't doing enough to protect public health. The film suggests this may be partially affected by conflicts of interests between the agency and medical device companies.