Christopher F Tenggardjaja1, Courtenay K Moore2, Sandip P Vasavada2, Jianbo Li3, Howard B Goldman2. 1. Department of Urology, Division of Female Pelvic Medicine and Reconstructive Surgery, Glickman Urologic and Kidney Institute, Cleveland Clinic, Lerner School of Medicine, Cleveland, OH. Electronic address: christopher.tenggardjaja@kp.org. 2. Department of Urology, Division of Female Pelvic Medicine and Reconstructive Surgery, Glickman Urologic and Kidney Institute, Cleveland Clinic, Lerner School of Medicine, Cleveland, OH. 3. Quantitative Health Sciences, Glickman Urologic and Kidney Institute, Cleveland Clinic, Lerner School of Medicine, Cleveland, OH.
Abstract
OBJECTIVE: To evaluate if new patients presenting to a female pelvic medicine and reconstructive surgery clinic are aware of the US Food and Drug Administration (FDA) announcement regarding transvaginal mesh placement for pelvic organ prolapse repair and do they believe there is a mesh recall. METHODS: A voluntary anonymous 25-question survey was administered to new-clinic patients. Participants were aged at least 18 years and had either urinary incontinence or pelvic organ prolapse. Appropriate statistical tests were performed for continuous and categorical variables. Logistic regression was used for univariate and multivariable analysis. Significance was considered for P values <.05. RESULTS: Two hundred fourteen surveys were included for final analysis. Of the 214 patients, 157 (73.4%) had urinary incontinence as their sole presentation. Of 204 patients, 126 (61.8%) were aware the FDA-released information regarding mesh use in transvaginal surgery, and 88 of 169 (52%) believed there is a "recall" on mesh being used for transvaginal surgery. Of 156 patients, 108 (69.2%) listed television as a source of information. On multivariable analysis, television as a source was significantly associated with awareness of the FDA announcement (odds ratio, 7.12; 95% confidence interval, 2.69-18.84; P = .0001) and belief in a "recall" (odds ratio, 3.01; 95% confidence interval, 1.28-7.06; P = .01). CONCLUSION: Although almost 2 of 3 participants were aware of the FDA announcement, more than half falsely believed there was a recall. Television was significantly associated with both awareness of the FDA announcement and belief in a recall suggesting patients derive most of their perceptions from the television.
OBJECTIVE: To evaluate if new patients presenting to a female pelvic medicine and reconstructive surgery clinic are aware of the US Food and Drug Administration (FDA) announcement regarding transvaginal mesh placement for pelvic organ prolapse repair and do they believe there is a mesh recall. METHODS: A voluntary anonymous 25-question survey was administered to new-clinic patients. Participants were aged at least 18 years and had either urinary incontinence or pelvic organ prolapse. Appropriate statistical tests were performed for continuous and categorical variables. Logistic regression was used for univariate and multivariable analysis. Significance was considered for P values <.05. RESULTS: Two hundred fourteen surveys were included for final analysis. Of the 214 patients, 157 (73.4%) had urinary incontinence as their sole presentation. Of 204 patients, 126 (61.8%) were aware the FDA-released information regarding mesh use in transvaginal surgery, and 88 of 169 (52%) believed there is a "recall" on mesh being used for transvaginal surgery. Of 156 patients, 108 (69.2%) listed television as a source of information. On multivariable analysis, television as a source was significantly associated with awareness of the FDA announcement (odds ratio, 7.12; 95% confidence interval, 2.69-18.84; P = .0001) and belief in a "recall" (odds ratio, 3.01; 95% confidence interval, 1.28-7.06; P = .01). CONCLUSION: Although almost 2 of 3 participants were aware of the FDA announcement, more than half falsely believed there was a recall. Television was significantly associated with both awareness of the FDA announcement and belief in a recall suggesting patients derive most of their perceptions from the television.
Authors: Anne G Sammarco; Carolyn W Swenson; Neil S Kamdar; Emily K Kobernik; John O L DeLancey; Brahmajee Nallamothu; Daniel M Morgan Journal: Obstet Gynecol Date: 2018-03 Impact factor: 7.661