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The Facts in The Bleeding Edge

The medical device industry has responded to the malfeasance exposed in our investigative documentary The Bleeding Edge.

Here are the facts:

The facts set forth in The Bleeding Edge are accurate and have been rigorously vetted by extensive research and multiple experts.

Bayer claims the portrayal of its harmful birth control device Essure in The Bleeding Edge “lacks scientific support” and is “inaccurate and misleading.” These claims are false.

The truth is that Essure was approved under an “expedited review” without randomized, nonblinded studies or a comparator group. These studies followed most participants for only 18 months, even though Essure is supposed to remain implanted for a woman’s lifetime. Some of the patient forms in the Essure studies were altered to reflect a more positive outcome than what was reported by the patient. Conceptus, the original manufacturer of Essure purchased by Bayer, hid more than 32,000 adverse events regarding Essure from the FDA.

Bayer’s attacks on three of the experts in The Bleeding Edge are without substance. There are no conflicts of interest regarding any of the experts in our film.

Dr. Diana Zuckerman is president of the non-profit National Center for Health Research (NCRH.) As an expert witness discussing her survey of Essure patients, she requested that the plaintiff’s attorney pay $375 to the NCRH. This represents no conflict because she says nothing about Essure in the film. Dr. Zuckerman has been quoted in the New York Times, the Washington Post and other media describing the need for well-designed, long-term research on Essure.

Dr. Julio Novoa is an experienced OB-GYN who surgically removes Essure from women who have been harmed by the device. For Bayer to suggest that he has “a financial interest in recommending the removal of the product” because he is being paid for doing his job is both cynical and false. Madris Tomes, a former public health analyst for the FDA, provides FDA public data and trends of adverse event reports to clients. Tomes has provided data expertise to the Essure Problems Facebook group pro bono.

On July 20, one week before The Bleeding Edge was released on Netflix, Bayer announced it would stop selling Essure after 2018.

In response to the film, Johnson & Johnson stated “providing safe and effective products is always our top priority.” This is contradicted by the fact that they released cobalt metal-on-metal hips as well as pelvic mesh despite knowing that there were significant safety risks with both.

Court records show that in 1995 a scientist from DePuy, whose parent company is J&J, warned about the dangers of their cobalt metal hip. After it was put on the market, surgeons, researchers and health officials repeatedly informed J&J that their hip device was harming patients, but it wasn’t until 2010 that J&J finally recalled the product, after it harmed tens of thousands of people.

Additionally, court records show that J&J also knew their pelvic mesh would injure women, but J&J chose to put the device on the market anyway. There are now tens of thousands of lawsuits filed against them by women harmed by mesh.

In response to the film, the FDA stated, “Often the true benefit-risk profile of a device cannot be fully understood until it can be evaluated when used in routine clinical practice.” This is far too late. To protect Americans, the FDA must establish that a device is safe before it is put on the market.

The FDA claims that it has taken “many steps” in recent years regarding Essure, but the FDA never took the most important step: recalling this flawed and dangerous device from the market in the U.S., especially after it had been taken off the market in the rest of the world.

The FDA, Bayer, Johnson & Johnson all declined to be interviewed for the film.

For deeper insight into the medical device industry, watch The Bleeding Edge on Netflix.