Feature Patient Safety

Watching over the medical device industry

BMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2321 (Published 23 June 2009) Cite this as: BMJ 2009;338:b2321

This article has a correction. Please see:

  1. Jeanne Lenzer, medical investigative journalist
  1. 1New York
  1. jeanne.lenzer{at}gmail.com

    Although all new drugs have to be tested to get regulatory approval, the same is not necessarily true for medical devices. Jeanne Lenzer reports on loopholes that are leaving patients at risk

    Lana Keeton was 54 when a surgeon used a synthetic mesh to create a pubovaginal sling to treat her for stress urinary incontinence. After her surgery in 2001, Ms Keeton developed a necrotising soft tissue infection at the operative site. Surgeons later found that the mesh had migrated and eroded through her bladder wall. During the past eight years, Ms Keeton has had numerous procedures and operations to remove pieces of the mesh and to treat recurrent urinary tract infections and pain. In October 2008, the US Food and Drug Administration warned that surgical meshes made by nine manufacturers, including the manufacturer of the mesh implanted in Ms Keeton, have been associated with serious complications, including bowel and bladder perforations, infections, and pain.1 Because of a little known loophole in the device approval process, the FDA did not require the manufacturers to submit safety or efficacy data before receiving approval to market their products.

    And it is not just surgical mesh that gets a free ride. An investigation conducted at the request of Congress by the US Government Accountability Office in January 2009, found that the FDA has never clinically reviewed many devices currently on the market, including some of the highest risk implantable devices.2 Another investigation, published in February 2009 by the US watchdog Project on Government Oversight, concluded that the device industry operates in an environment akin to the “Wild West days, when manufacturers were free to set their own rules and standards without interference from the FDA.”3

    Even when devices undergo the most rigorous level of FDA review, known as premarket approval, …

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