Healthy Skepticism Library item: 15877

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Lenzer J.
Patient Safety: Watching over the medical device industry
BMJ. 2009 Jun 23; 338:
http://www.bmj.com/cgi/content/extract/338/jun23_1/b2321

Abstract:

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 . . .