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A victim of a poorly researched and regulated medical devices recounts her horrific experience in ‘The Bleeding Edge’. Image Credit: Supplied

The surgery scenes in The Bleeding Edge are squirm-in-your-seat uncomfortable. But it’s the interviews — watching patients recount agonies they’ve suffered from poorly researched and regulated medical devices — that are hardest to sit through.

“When it comes to medical devices, we built a system that doesn’t work” for proper regulation, says Dr. David A. Kessler, a former commissioner of the Food and Drug Administration. The multibillion-dollar industry has exploited those flaws, and Kirby Dick (The Invisible War, Twist of Faith), the documentary’s director, spotlights infuriating examples and conflicts of interest.

We learn of former FDA officials hired by companies they once regulated, and see business executives named to government positions. That revolving door has been reported elsewhere, and often. Yet as outlined here, corporate influence has reached a point that might seem comical were patients’ lives not being wrecked.

Dick smartly summarises complex procedures and cites exasperating statistics. His script is better still at introducing people affected by the products. The interviewers — Amy Ziering, aided by Amy Herdy and Dick — coax out dozens of quotes and anecdotes you’ll wish were heard by every government official.

The hard-hitting documentary holds manufacturers, medical professionals and the FDA responsible for the state of affairs.

Ana Fuentes, a mother of four, chose Essure as a contraceptive. She and others say they have experienced excruciating pain since being implanted with it. (Last week, Bayer, the maker of Essure, said it will end sales of the device.) Fuentes says she is now unable to work because of complications. Her experiences described here, and the toll they take on her children, are heartbreaking.

Stephen Tower, a physician, received a chrome-cobalt replacement hip, which he suspects poisoned him and led to a mental breakdown. Another segment, on complications said to be caused by vaginal mesh, is particularly harrowing; the mesh, whose potential to create serious problems was long known, “costs about $25 (Dh92) to bring to market, and they sell for about $2,000,” says an obstetrician. In such cases, if there’s a disagreement between the marketing and the medicine, “the marketing is always going to win out,” says a lawyer for injured patients.

A sales representative, whose identity is shielded, discusses financial incentives used to coax surgeons to implant devices: “It’s gotten worse over time because of greed.” An on-screen statistic notes that medical companies paid doctors more than $2 billion in 2016.

The Bleeding Edge isn’t an anti-medical film, but a look at calamities caused when the obsession for profit overwhelms an industry. Dick uses no devious camera tricks, and the soundtrack, by Jeff Beal, is tense yet restrained. Indeed, the filmmakers aren’t shouting “Fire” in a crowded theatre. For them and their subjects, the inferno has already occurred. Now they’re sweeping up the ashes, and warning of new blazes sure to come.

The Bleeding Edge is now streaming on Netflix.