Women's Health Update - March 2019

Message from the Acting Associate Commissioner

As we celebrate Women's History Month and recognize the contributions made by women to our society, I am honored to join the FDA Office of Women's Health (OWH). Over the past 25 years, OWH has promoted the health of women through regulatory science, research, and outreach. I look forward to meeting and working with you as we continue to collectively protect and advance women’s health. Kaveeta P. Vasisht, M.D., Pharm.D. Acting Associate Commissioner Deputy Director

Introducing Our Outreach and Communications Director

I’m excited to be among the new faces representing the FDA Office of Women’s Health. As the Director of Outreach and Communications, I anticipate meeting and collaborating with you in the future to continue to advance our collective missions. Rashetta Fairnot, MSW, LMSW Director of Outreach and Communications

FDA Warns Thermography Should Not Be Used in Place of Mammography to Detect, Diagnose, or Screen for Breast Cancer The FDA is alerting women, health care providers, and people getting breast cancer screening, that thermography is not an effective alternative to mammography and should not be used in place of mammography for breast cancer screening or diagnosis. Mammography (taking X-ray pictures of the breasts) is the most effective breast cancer screening method and the only method proven to increase the chance of survival through earlier detection. Read the FDA Safety Communication. FDA issues warning letter to clinic illegally marketing unapproved thermography device, warns consumers to avoid using thermography devices to detect breast cancer. FDA Advises Consumers on Claire’s Cosmetic Products The FDA sampled and had tested targeted cosmetic products following reports of contaminated cosmetics marketed by Claire’s. Consumers who have these batches/lots of Claire’s Eye Shadow, Compact Powder, and Contour in their home should stop using them. Claire’s has informed us that it does not believe that affected products are still available for sale. Read the full Safety Alert. Read the FDA Statement from FDA Commissioner Scott Gottlieb, M.D., and Susan Mayne, Ph.D., director of the Center for Food Safety and Applied Nutrition, on tests confirming a 2017 finding of asbestos contamination in certain cosmetic products and new steps that FDA is pursuing to improve cosmetics safety. FDA advances new proposed regulation to make sure that sunscreens are safe and effective FDA issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States. This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Read the FDA News Release. Read “Sunscreen: How to Help Protect Your Skin from the Sun. Robotically Assisted Surgical Devices for Mastectomy and Other Cancer Related Surgery The U.S. Food and Drug Administration issued a safety communication to patients and health care providers urging caution when using robotically-assisted surgical devices for mastectomy and other cancer related surgeries. Robotically-assisted surgical devices enable surgeons to perform a variety of surgical procedures through small incisions in a patient’s body. This type of surgery may help reduce pain, blood loss, scarring, infection and recovery time after surgery in comparison to surgical procedures that do not use these devices. Computer and software technology allow a surgeon to control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in three-dimensional high definition. Read the full FDA In Brief. Read the FDA Safety Communication: Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication. FDA authorizes first interoperable insulin pump intended to allow patients to customize treatment through their individual diabetes management devices FDA permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Read the FDA News Release. FDA's continuing efforts to educate patients on known risk of lymphoma from breast implants FDA wants to increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant. Read the full Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) – Letter to Health Care Providers. Read the FDA Statement from Binita Ashar, M.D., of the FDA’s Center for Devices and Radiological Health on agency’s continuing efforts to educate patients on known risk of lymphoma from breast implants. Visit FDA’s Breast Implants webpage.

National Women and Girls HIV/AIDS Awareness Day (NWGHAAD) is March 10, 2019 The purpose of NWGHAAD is to raise awareness of the impact that HIV and AIDS have on women and girls. The theme, “HIV prevention starts with me” reminds us that everyone has a role to play in HIV prevention. Get involved by sharing these resources.  Download and order FDA’s Women and HIV fact sheet. Retweet our #NWGHAAD Twitter message on March 10. Visit the HHS Office on Women’s Health NWGHAAD webpage. American Diabetes Alert Day is March 26, 2019 Nine out of 10 adults with prediabetes don’t know they have it. American Diabetes Alert Day sounds the alarm to inform the American public about the seriousness of diabetes, particularly when diabetes is left undiagnosed or untreated. Get the facts about diabetes and FDA approved medicines used to treat diabetes. Retweet our #DiabetesAlertDay Twitter message on March 26. Take the Diabetes Risk Test to find out if you may be at risk for diabetes or prediabetes.

Participate in Upcoming FDA Meetings

FDA and ASCPT Co-Sponsored ASCPT 2019 Pre-conference: PBPK Modeling for the Development and Approval of Locally Acting Drug Products March 13, 2019 FDA Grand Rounds: The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography March 14, 2019 2019 Oncology Center of Excellence Childhood Cancer Advocacy Forum March 15, 2019 Neurological Devices Panel of the Medical Devices Advisory Committee Meeting Announcement March 21, 2019 FDA-NBTS Public Workshop: Product Development for Central Nervous System (CNS) Metastases March 22, 2019 General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee March 25 – 26, 2019 Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting Announcement March 27, 2019