Are Women Aware of FDA-510K Lubricant Clearance? [40F]. (May 2018)

• Record Type: Journal Article
• Authors: Krychman, Michael
• Is Part Of: Obstetrics and gynecology. Volume 131(2018)Supplement 1
• Publication Date: 2018-05
• Subjects: Obstetrics -- Periodicals; Gynecology -- Periodicals; 618
• DOI: 10.1097/01.AOG.0000533350.33374.f4
• Languages: English
• ISSNs: 0029-7844

Abstract

Abstract : INTRODUCTION: Vaginal products have come under greater scrutiny with the consumer awareness campaign that has focused on additives and potential chemical irritants, acid base balance, chemicals or carcinogens in these products. Class II medical device 510(k) clearance is a premarket submission, made directly to the FDA that includes sufficient evidence to demonstrate that the lubricant/device is safe and effective. METHODS: An in office observational survey was completed to investigate whether lubricant consumers were aware if the lubricant they were using was 510(k) cleared. Fifty popular lubricant products were reviewed as to if they designated 510(k) clearance on their home page. RESULTS: Fifty women, (mean age 48) were assessed. Ninety six percent of the woman were not aware if their lubricant was 510(k) cleared. Ninety-six percent of the women did not have understanding of what the 510(k)-clearance specified. All women were unaware if their lubricant contained additives such as bactericides, or other caustic chemical. A total of 50 lubricants (30 water; 20 silicone products) were assessed. Fifty percent of (water based) were deemed to be 510(k) cleared by the FDA whereas only 14% of those mentioned this designation on their website. Fifty percent of the silicone lubes were 510(k) cleared and only 5% of them mentioned it on their websites. CONCLUSION: Most women are not aware of the 510(k) designations nor are they familiar with its significance and meaning. Companies are remiss in educating women about this important safety, efficacy and product designation.