Gulf News

Hard look at victims of medical devices

Patients recount agonies they’ve suffered from poorly researched and regulated medical devices in ‘The Bleeding Edge’, an incisive medical documentar­y

- By Ken Jaworowski

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 multibilli­ondollar 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 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 that should be heard by the government.

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.) Fuentes says she is now unable to work because of complicati­ons. Her experience­s 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,” 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. 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.

 ?? Photos supplied ?? Don’t miss it!The BleedingEd­ge is now streaming on Netflix. A victim of a poorly researched and regulated medical devices recounts her horrific experience in ‘The Bleeding Edge’.
Photos supplied Don’t miss it!The BleedingEd­ge is now streaming on Netflix. A victim of a poorly researched and regulated medical devices recounts her horrific experience in ‘The Bleeding Edge’.
 ??  ?? The hard-hitting documentar­y holds manufactur­ers, medical profession­als and the FDA responsibl­e for the state of affairs.
The hard-hitting documentar­y holds manufactur­ers, medical profession­als and the FDA responsibl­e for the state of affairs.

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