THE BLEEDING EDGE CRITICISM MOVIE
THE BLEEDING EDGE CRITICISM FULL

Bayer strongly encourages women with Essure who have questions or concerns to consult with their physicians. The IFU is based on scientific/clinical data and opinions from medical experts worldwide. Moreover, the singular focus on hysterectomy is inconsistent with Essure's FDA-approved Instructions for Use (IFU), which state that 'hysterectomy generally is not required to remove the Essure inserts' as there are other methods identified in the IFU.

Providing women with inaccurate or misleading information about the safety of Essure, or encouraging removal via hysterectomy, is potentially a serious public health issue as it may lead women with Essure to unnecessarily seek removal, and can result in new or additional health problems. The film provides no balance on this important topic.

THE BLEEDING EDGE CRITICISM MOVIE

No discussion of the movie and Essure should ignore the issue of removal, which most women featured in the film discuss. This is summarized in FDA's executive summary prepared in advance of the 2015 Advisory Committee. This omission is important because in the Phase II and Pivotal trials at follow up time points of three, six, 12, 18, 24, 36, 48, and 60 months, at least 99% of women were reported to have rated comfort of wearing the Essure inserts as 'good' or 'excellent.' In the Pivotal trial, at least 97% of women were reported to be 'somewhat' to 'very satisfied' at all visits through five years. Still, it is notable that not a single woman who is satisfied with Essure is included in the film. Bayer takes any concerns regarding its medicines and devices seriously. Most of the movie's focus on Essure is told not through science, but rather through the stories of women who reported concerns about the device. The FDA also has not changed its conclusion that Essure's benefits outweigh any potential risks. The totality of scientific evidence, which was not discussed in the film, includes 40 published studies involving approximately 200,000 women over two decades, and demonstrates the safety and efficacy of Essure, which has remained consistent over time. ' The decision by the filmmakers to exclude highly relevant conclusions from a study they cited, apparently because they conflict with their desired narrative, do raise serious concerns about the objectivity and accuracy of the movie. The authors of the study concluded: 'These findings do not support increased medical risks associated with hysteroscopic sterilization. The independently funded research compared women with Essure to those who had tubal ligation surgery, the only other method of permanent birth control, and found that many of the concerns described in the film with regard to Essure - pain (analgesic use) and hysterectomy - were lower in Essure patients than in tubal ligation patients at both one and three years post procedure.

Taken as a whole, the study actually undermines the central premise of the film's representation of Essure. Notably, the film's only reference to scientific data regarding Essure is the 2018 Bouillon study published in the Journal of the American Medical Association ('JAMA'), which its producers cite out of context and portray in its least favorable light. This does a disservice to the thousands of women who rely on Essure for their reproductive health, as it may encourage them to pursue risky and unnecessary surgery to remove the device. The film also relies on many conflicted sources without disclosing their potential biases.

THE BLEEDING EDGE CRITICISM FULL

The film presents an inaccurate and misleading picture of Essure by relying almost entirely on anecdotes, cherry-picking information to fit a predetermined conclusion, ignoring the full body of scientific evidence that supports the Food and Drug Administration's (FDA) determination that Essure's benefits outweigh its risks and disregarding the appropriate warnings that accompany the device. In contrast, the portrayal of Essure in The Bleeding Edge lacks scientific support, despite the fact that Bayer provided the producers with extensive scientific information on Essure before the completion of the film. Bayer also is reminding women with Essure that the safety profile of the device remains positive and unchanged.Īs a leader in women's healthcare, Bayer believes strongly that women and their physicians should make reproductive health decisions based on sound science. This Fact Check is based on Bayer's review of the film's premiere at the Tribeca Film Festival on Apand is intended to encourage a science-based conversation about Essure.

WHIPPANY, N.J., J/PRNewswire/ - Bayer today released a Fact Check of The Bleeding Edge, which premieres on Netflix on July 27, devotes significant time to Essure, the only FDA-approved non-incisional form of permanent birth control, and is now the subject of media coverage by The New York Times, CBS News, and others.

The bleeding edge criticism