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Female Pelvic Medicine & Reconstructive Surgery:
doi: 10.1097/01.spv.0000370764.85829.8d
SGS Abstracts

Oral Presentation 5: Informed Consent Practice Patterns For Midurethral Sling Surgery: The Effect Of The Fda Notification

Hammil, S. L.1; Rogers, R. G.1; Abed, H.3; Schrader, R.2; Davis, M.4

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1OB/GYN, University of New Mexico, Albuquerque, NM; 2Mathematics and Statistics, University of New Mexico, Albuquerque, NM; 3OB/GYN, Henry Ford Hospital, Detroit, MI; 4Urology, University of New Mexico, Albuquerque, NM

DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS: None.

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OBJECTIVES:

To describe informed consent practices for midurethral sling (MUS) procedures and how consenting practices have changed since the Food and Drug Administration (FDA) notification in 2008.

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MATERIALS AND METHODS:

Three hundred and ninety-nine (399) surgeons who regularly perform MUS surgeries for stress urinary incontinence were surveyed regarding their surgical consent practices. They were asked to describe both the level of detail and the specific details they provide to patients during informed consent for MUS surgery. Surgeons also provided information regarding whether they had altered their consent practices according to the FDA notification issued in 2008. Surgeons described their baseline demographics and were queried regarding their educational background including residency and fellowship training.

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RESULTS:

Most respondents were male (55%), over 40 (57%) and had ≥10 years experience after residency (48%). Fifty-two percent (52%) of surgeons underwent fellowship training in either Female Urology or Female Pelvic Medicine and Reconstructive Surgery. Sixty-one percent (61%) reported performing ≥5 MUS surgeries per month. There was no difference in the reported level of detail provided to patients regarding risks, benefits and alternatives to MUS surgeries based on age, fellowship training or surgical volume. However, differences did exist in the specific details provided. Younger surgeons were more likely to counsel patients about behavioral therapy (80 vs. 70%, P = 0.028), weight loss (78 vs. 68%, P = 0.024) or pessary use (82 vs. 69%, P = 0.005) as alternatives to MUS surgery than older surgeons. Older surgeons were more likely to offer patients medications (39 vs. 28%, P = 0.026) as an alternative to MUS surgery. Fellowship trained surgeons were more likely to recommend behavioral therapy (80 vs. 69%, P = 0.002) or a fascial sling (29 vs. 14%, P < 0.001) as an alternative to MUS surgery than surgeons not fellowship trained. Physicians who performed a high volume of slings (>5/month) were more likely to recommend pelvic floor muscle exercises (98% vs. 93%, P = 0.019) and behavioral therapy (78 vs. 68%, P = 0.032) than those performing <5 slings/month. Fellowship trained and higher volume surgeons were more likely to spend greater than 20 minutes counseling patients for informed consent. Most respondents (53%) stated that they had not changed their consent practices based on the FDA notification. Almost all surgeons (99%) reported informing patients that vaginal mesh is permanent but only 13% reported issuing a written copy of the patient labeling from the surgical mesh manufacturer to the patient. Surgeons who had not undergone fellowship training were more likely to have changed their consent practices in response to the FDA notification (52 vs. 41% P = 0.039) than those with fellowship training.

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CONCLUSION:

Fellowship trained surgeons and those with higher surgical volumes were more likely to offer a variety of alternatives to MUS surgery and spend more time in surgical consent counseling. The majority of surgeons performing MUS surgery have not changed their consent practices in response to the FDA notification, and few comply with all the FDA recommendations for MUS surgical consent.

Keywords:

TVT; surgical counseling; vaginal graft; informed consent; FDA notification

© 2010 by Wolters Kluwer Health | Lippincott Williams & Wilkins

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