August FDA Women's Health Update

August 2014 www.fda.gov/womens Message from the Director As you transition from your summer outreach to planning for fall activities, I encourage you to look to FDA for resources. In this update, you will find links to back-to-school resources, tips for breastfeeding mothers, and announcements for several upcoming meetings and conference exhibits. FDA Women's Health highlights Registration Open for FDA Meetings on Female Sexual Dysfunction FDA will conduct a Patient-Focused Drug Development Public Meeting and a Scientific Workshop on female sexual dysfunction (FSD) on October 27 – 28, 2014 at FDA's White Oak Campus in Silver Spring, MD. On Day 1, FDA is interested in obtaining patient input on the most common form of FSD, female sexual interest/arousal disorder (FSIAD). On Day 2, there will be a scientific workshop to discuss how best to facilitate the development of safe and effective drug therapies to treat FSIAD and how best to identify valid patient-reported outcome measures to determine whether disease symptoms improve with specific interventions. Register for the Meeting: http://patient-focused-female-sexual-dysfunction.eventbrite.com  Wrinkle Fillers and other Facial Fillers Wrinkle fillers, also known as dermal fillers or facial soft tissue fillers, are approved by FDA for use in helping to create a smoother and/or fuller appearance in the face. These products are used for correcting defects in the face, such as moderate to severe facial wrinkles and skin folds, lip and cheek augmentation, and to restore or correct the signs of facial fat loss in people with HIV. Most dermal fillers injected into the skin have a temporary effect, because over time they are absorbed by the body. FDA has approved only one product made from a material that remains in the body and is not absorbed.   FDA has not approved dermal fillers for increasing breast or buttock size or for injections anywhere other than in the face. FDA has not approved liquid silicone or silicone gel for injection to fill wrinkles or augment tissues anywhere in the body.   Get the Facts before Using Fillers: Consumer Update: Filling in Wrinkles Safely Dermal Fillers List of Approved Dermal Fillers Back to School Resources FDA has resources to help parents of young children, teens, and college students prepare for the school year. Use these resources to help keep students safe.  College Women's Health webpage The Real Cost – Youth Tobacco Prevention Vaccines for Children: A Guide for Parents Medication Tips for Parents Food Safety and Nutrition Materials for Kids  Pregnancy Twitter Chat: August 28 FDA's Office of Women's Health (@FDAWomen) is joining the National Institute of Child Health and Human Development (@NICHD_NIH) and @MarchofDimes for a #pregnancychat on Twitter on August 28 from 2–3 p.m. EDT.  The chat will focus on ways in which women can ensure a healthy pregnancy. It will also highlight Know Your Terms, NIH's new initiative for parents-to-be and health care professionals. Extras FDA Resources for Breastfeeding Mothers Breast pumps are medical devices regulated by the FDA. These devices are often used by breastfeeding women to extract ("express") their breast milk. FDA has general tips to help women choose, use, and clean breast pumps.   Breast Pumps Website Consumer Update: Breast Pumps: Don't Be Misled Other Tips for Pregnant Women and New Mothers  FDA Meetings PUBLIC HEARING: Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials August 11, 2014 - 8 a.m. to 5 p.m. FDA White Oak Campus, Silver Spring, MD   OWH Conference Exhibits National Conference on Health Communication, Marketing & Health – August 19-21, Atlanta, GA National Alliance on Mental Illness –September 4-5, Washington, DC  Please share this update with your network, members, constituents, and community FDA Office of Women's Health 10903 New Hampshire Avenue WO32 - Room 2333 Silver Spring, MD 20993*0002 301-796-9440

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