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March 2019 Office of Women's Health e-Update

Message from the Acting Associate Commissioner

Photo of Kaveeta P. Vasisht, MD, PharmD

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

photo of Rashetta Fairnot

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

Women's Health Highlights

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.

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.

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.

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.

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.

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.

Call To Action

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.

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.

Participate in Upcoming FDA Meetings

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