Published 23 June 2009, doi:10.1136/bmj.b2321
Cite this as: BMJ 2009;338:b2321

Feature

Patient Safety

Watching over the medical device industry

¹ New York

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

The first 150 words of the full text of this article appear below.

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 . . . [Full text of this article]

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