The Bleeding Edge. Directed by Kirby Dick. Los Gatos, CA: Netflix, 2018. 100 minutes.

bOObs: The War on Women’s Breasts. Directed by Megan S. Smith. Burbank, CA: Cinema Libre Studio, 2020. 97 minutes.

It can be difficult for the average person to sift through information about medicine and healthcare. Scholarly publications are often difficult to understand—if they aren’t hidden behind a paywall—and in countries with direct-to-consumer advertising, the barrage of information about the latest pharmaceuticals treats drugs like other consumable goods we might buy in a grocery store.1 The films reviewed here approach the use and abuse of medical technologies from different perspectives, raising important questions about diagnostic and treatment options as well as how those options are presented to us.

The Bleeding Edge opens with a series of inspirational quotes from medical technology conferences, culminating in the rallying cry: “Let’s continue to improve lives by unleashing innovation” (1:54). What follows are several narrative accounts of how unproven medical technologies have unleashed nothing but pain and suffering for some patients, leading to a call for better regulation of an industry now considered to be more powerful than “big pharma.” The film explores the “quackery” of the past (11:53) and how this legacy has led to insufficient safety standards in the present, manifested in the Food and Drug Administration’s (FDA) Regulation 510(k) allowing medical device companies to bring their products to market without stringent testing, so long as they can prove it is “substantially equivalent” to an existing approved device (18:30). The documentary claims that 98 percent of products are approved through this pathway, causing a daisy-chain effect where one product is approved on the basis of a “predicate device,” which itself was approved due to similarities to an earlier device, etc. Even if the original (or predicate) device is later recalled for safety or efficacy reasons, subsequent approvals based on the original are still possible. Throughout The Bleeding Edge, it is made clear that both doctors and patients overestimate the level of testing and oversight of medical device companies.

This film is effective in exploring the human side of “adverse events” reporting requirements, illustrating that the impact of these technologies goes beyond data. For example, it shows mothers unable to work or care for their children due to debilitating health issues following implantation of the permanent sterilization device, Essure, produced by Bayer (4:18; 65:14). An orthopedic surgeon relates his own experience of cobalt poisoning from a hip replacement, leading him to study this in other patients, several of whom may have been misdiagnosed with dementia (15:11; 94:28). Vaginal mesh is then discussed in conjunction with the number of lawsuits this product has led to and accusations that Johnson & Johnson suppressed risk data (35:24; 93:20). As the filmmakers note, due to 510(k) the product did not require clinical trials before market release. Also primarily harming women, the Da Vinci surgical robot used in hysterectomies has caused some patients to experience prolapse of other organs (56:29). During the approval process, the manufacturer, Intuitive Surgical, claimed the machine would be safe because surgeons would receive extensive training on it, which they immediately scaled back after FDA approval. Other ethical issues discussed include kickbacks to doctors for implanting certain devices (55:30) and concerns that the FDA has employed retaliatory tactics and spying software against scientists trying to blow the whistle on safety concerns (74:33). The film suggests a link between these practices and the fact that many FDA officials come from the medical device industry and return there after their time with the agency, sparking a potential conflict of interest.

Although The Bleeding Edge focuses on injury and harm, it also highlights moments of resistance. Based on their experiences with Essure, some women formed a global network demanding action to make the risks of this device public, starting with a Facebook page and ending with Congress. From a feminist perspective, the camaraderie of these women in the face of medical gaslighting and institutional racism in some cases is inspiring. Moreover, the final textual overlay notes that following the premiere of The Bleeding Edge, Bayer announced they would be removing Essure from the US market. This is likely to generate class discussion on the power of advocacy groups and media to create change.

The major benefit of using this film in class is the detailed case studies and data provided. Throughout the film, textual overlays communicate startling statistics and facts about the devices being discussed. However, the stories jump around a bit, and the film is very US-centric, so may not be generalizable. There are also some graphic scenes of medical procedures that might make some students uncomfortable.

bOObs: The War of Women’s Breasts also opens with a strong perspective on medical technology: a doctor reports that they will never get a mammogram because there is a “better test” (:13) before a textual overlay tells the audience that much of the documentary goes against “conventional medicine” and that “some of it may be difficult to believe. But don’t take our word for it… citations are contained herein” (:28).  This is a promising start for a film that might be expected to generate a lot of classroom discussion about healthcare (particularly in the United States) and journalism techniques. What follows is unfortunately a rather unbalanced and sometimes flippant account of a major threat to women’s health: breast cancer.

Audiences may be justly surprised to hear data, such as the information that a mammogram is the equivalent of one hundred chest X-rays in terms of radiation dose, miss half the cancers they are intended to catch, and overdiagnose cancers in healthy patients (false positives) leading to unnecessary and invasive follow-up tests, chemotherapy, radiation, and surgical interventions. Some of the sources interviewed explain that mammography is less than 50 percent effective at detecting tumors for women with dense breast tissue. The documentary then goes on to debunk other “myths” and supposed inaccuracies about the value of mammography through personal accounts and scientific data that viewers may find compelling.

While the film raises legitimate scientific and ethical concerns, including lack of informed consent, misdiagnosis, overtreatment, and conflicts of interest impacting treatment guidelines and insurance coverage, its overreliance on cheap shots, logical fallacies, and individuals’ personal experiences undermines the project. The film frames comments from a conventional doctor in a mocking way, and it uses humorous and whimsical text overlays, profanities, and a B-grade horror soundtrack. The lines “Doctors are fed myths” (51:47) and “it’s a belief system… they’ve been indoctrinated” (56:43) rely on appeals to emotion rather than valid data to target the one breast cancer surgeon who is not suggesting abandoning mammography as the standard of care. Western medicine is further disparaged when quotes such as “I never trust the literature” (83:24) are repeated out of context alongside quotes from medical journal editors, suggesting that half of published medical “evidence” is false. And the director herself undergoes thermography and ultrasound as alternative first-line screening tests and then shares her “improvements” over time in supposedly reducing her risk of breast cancer development due to healthy lifestyle choices.

Educators using this film may want to unpack its contradictory logic, as well. bOObs critiques scientific literature while citing that same published literature to support its case. It also notes that the “alternative” diagnostic tests (that it recommends) are often not covered by insurance and that thermography is not regulated by the FDA. The issue of doctors receiving kickbacks for referring women for mammography is discussed while also pointing the finger at regulatory bodies for failing to act in the interests of women.

Overall, the issue of overdiagnosis and treatment of breast cancers due to mammography is an important feminist issue that deserves widespread discussion. For example, the documentary claims that women with cancers in situ aren’t given the option to “watch and wait” (34:56) while this is considered standard practice for men with some cancers, which offers insight into institutional sexism. However, this documentary needs to be taught alongside media studies so the impact of valence framing (where statistically equivalent information is presented in either a positive or negative way, e.g., as a potential loss or gain) and other techniques can be considered (see, e.g., Richmond et al. 2023; Bell and Burton 2012).

1 Geography affects the extent to which people are exposed to pharmaceutical advertising; Australia, for example, bans this practice.

Dr Evie Kendal is an emerging technology bioethicist whose work focuses on reproductive biotechnologies and space ethics. She is currently working as a senior lecturer of health promotion at Swinburne University of Technology in Victoria, Australia. Evie’s research interests include artificial womb technology, ethical issues in aerospace medicine, and public health education.