Reflection Paper Undergraduate 692 words

The Bleeding Edge: Medical Device Risks and FDA Approval

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Abstract

This paper reviews The Bleeding Edge (2018), a Netflix documentary directed by Kirby Dick that investigates the $400 billion U.S. medical device industry. The paper summarizes the film's examination of specific implantable devices — including metal-on-metal hip replacements, the Essure contraceptive, and Johnson & Johnson's transvaginal mesh — and the serious harms associated with each. It also outlines the FDA's device approval pathways, including pre-market approval (PMA), pre-marketing notification, and the humanitarian use device designation, noting the film's critique of these processes as inadequate. The paper concludes with a personal reflection on how the documentary reshaped the author's view of medical device commercialization and patient safety.

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What makes this paper effective

Concisely summarizes the documentary's core argument while supporting claims with academic and industry sources, adding scholarly credibility beyond the film itself.
Moves logically from specific device examples to systemic regulatory critique, demonstrating cause-and-effect reasoning rather than simple plot summary.
The personal reflection section honestly connects course content to the author's own evolving perspective, which gives the paper an appropriate reflective dimension.

Key academic technique demonstrated

The paper effectively uses a media source (a documentary film) as the primary lens while grounding its regulatory analysis in a peer-reviewed journal article (Van Norman, 2016). This combination — popular media plus scholarly literature — is a useful technique for film-response or reflection assignments, showing the student can contextualize a secondary source within verified academic evidence.

Structure breakdown

The paper opens with an introduction to the documentary and its scope, moves into a body paragraph cataloguing three specific devices and their documented harms, follows with a detailed explanation of FDA approval mechanisms drawn from the academic literature, and closes with a first-person reflective paragraph. This four-part structure suits a short undergraduate response paper and keeps the argument focused throughout.

Introduction

The Bleeding Edge is a Netflix documentary that examines the $400 billion medical device industry, which produces and markets highly complex apparatuses implanted into human bodies (Dick, 2018). The film was made on the premise that more than 70 million Americans have been outfitted with internal medical devices. While numerous medical devices help uplift and save lives — such as corneal transplants and hip replacements — the film focuses primarily on devices that have harmed people. Through this exposé, the documentary provides shocking revelations regarding medical devices implanted in people's bodies in attempts to enhance their health and wellbeing.

Medical Devices Featured in the Film

One of the medical devices discussed in the film is hip replacement, which has traditionally been a highly effective procedure. This device is implanted in an individual's body to help restore mobility and relieve pain caused by hip diseases or injuries such as arthritis. However, the conventional hip replacement device has been modified in attempts to improve its effectiveness. These modifications have been characterized by side effects, including leakage of cobalt into the body, which can generate both physical and mental health complications (Gleiberman, 2018).

The Bleeding Edge also discusses Essure, a permanent contraceptive device used for birth control. This device is inserted by an Essure-trained physician through the natural pathways of the body — including the cervix and vagina — into the fallopian tubes. Essure has been associated with side effects including excruciating pain, which can contribute to difficulties in daily functioning and workplace performance due to ongoing complications.

Another medical device featured in the film is transvaginal mesh, produced by Johnson & Johnson. This device is used for pelvic repairs by implanting it into the vaginal wall. The side effects and potential harms associated with transvaginal mesh include pelvic pain, bleeding, organ perforation, and pain during sexual intercourse.

2 Locked Sections · 320 words remaining

42% of this paper shown

FDA Approval Pathways for Medical Devices · 215 words

"PMA, PNM, and humanitarian device approval routes"

Reflections on the Medical Device Industry · 105 words

"Author's changed perspective on device commercialization"

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Key Concepts in This Paper

Medical Device Regulation FDA Approval Pre-Market Approval Transvaginal Mesh Essure Contraceptive Hip Replacement Patient Safety Device Commercialization Humanitarian Use Device The Bleeding Edge