September 2012
Message from the Director
Often the public does not get the chance to see the work done by FDA to promote women’s health. Much of the work is done behind the scenes… compiling and analyzing data, coordinating workshops, developing fact sheets, and connecting groups to FDA resources. My hope is that this eUpdate and our other web efforts will help pull back the curtains so that you will not only see the fruits of our labor but also collaborate with us to strengthen these efforts. Take a look at two recent summaries of our work to promote sex differences research. Also, view and order some of our new consumer publications. Lastly, keep checking the FDA For Women website for links to resources for consumers and health professionals.
Before ending this message, I would like to welcome Dr. Pamela Scott to OWH as the new Director of the Research and Development Program. Dr. Scott has held several regulatory and research positions at FDA in the areas of epidemiology, clinical trials, and women’s health. I would also like to congratulate Dr. Janine Clayton on being named Director of the NIH Office of Research on Women’s Health (ORWH). Dr. Clayton has been serving as ORWH Acting Director since August 2011. I look forward to working with both of them to advance women’s health research.
Marsha Henderson, MRCP
Assistant Commissioner for Women’s Health
OWH Research
Journal Article on OWH/SWHR-sponsored Clinical Trials Symposium
The Dialogues on Diversifying Clinical Trials Conference was convened to address the need for greater representation of women and minority groups in the development of medical products. A recent article in the Journal of Women’s Health outlines strategies discussed at the meeting including community-based approaches to clinical trial design and strategies for improving recruitment and retention.
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OWH invited to meet with Leading International Research Institute
The summary report is now available online for OWH’s June 2012 meeting with representatives from the Centre for Gender Medicine at Karolinska Institutet (KI) of Sweden. The meeting included presentations on OWH and Karolinska research and data initiatives as well as presentations from the FDA Sentinel Initiative.
OWH Outreach
Order a Wiser Woman Action Kit during Healthy Aging Month
Throughout September, OWH has offered a free publication kit to provide women with health tips and helpful FDA resources on mammograms, diabetes medicines, health scams, and more. There are still kits available.
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Updated Consumer Fact Sheets Now Available
OWH is committed to providing consumers with up-to-date and accessible health information. The re-formatted ‘Women and HIV’, ‘Food Safety at Home’, and ‘Medicine and Pregnancy’ fact sheets are now posted online in English and Spanish. Check the website in the coming months for more new publications.
FDA Advisory Committee Meetings
- Radiological Devices Panel of the Medical Devices Advisory Committee – Oct 24
- Nonprescription Drugs Advisory Committee – Nov 9
FDA Highlights
FDA Expands Caution about SimplyThick
FDA wants parents, caregivers and health care professionals to be aware that infants of any age may face an increased risk of developing a life-threatening condition if fed a thickening product called SimplyThick. SimplyThick is a brand of thickening agent—available to consumers and medical centers—used to help manage swallowing difficulties.
Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died.
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FDA Approves First Breast Ultrasound Imaging System for Dense Breasts
On September 18, 2012, FDA approved the first ultrasound device for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer. The National Cancer Institute estimates that about 40 percent of women undergoing screening mammography have dense breasts. These women have an increased risk of breast cancer, with detection usually at a more advanced and difficult to treat stage. Ultrasound imaging has been shown to be capable of detecting small masses in dense breasts.
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Repairing Pelvic Organ Prolapse: What’s Best?
As part of FDA's Expert Commentary Series on Medscape, Dr. Diane Mitchell, Assistant Director for Science in the FDA Center for Devices and Radiological Health provides a video commentary on the risks of using surgical mesh to repair pelvic organ prolapse, also known as POP.
FDA’s review indicates that urogynecologic surgical mesh products are associated with serious adverse events, including mesh erosion through the vaginal wall. This complication can require multiple surgeries to repair, and sometimes the mesh cannot be completely removed, which leads to continued symptoms.
View FDA’s Commentary on Medscape
Read FDA’s Literature Review on Urogynecologic Surgical Mesh
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Tattoo Inks Pose Health Risks
People from all walks of life have tattoos, which might lead many to believe that tattoos are completely safe. But there are health risks that can result in the need for medical care. FDA is particularly concerned about a family of bacteria called nontuberculous Mycobacteria (NTM) that has been found in a recent outbreak of illnesses linked to contaminated tattoo inks.
Update Extras
Conferences
OWH exhibits and presents at conferences across the country to increase awareness of OWH programs and resources and to increase dissemination of the over 40 OWH fact sheets and brochures available for consumers. Check out an OWH exhibit booth or presentation at one of these conferences:
Reproductive Health 2012, Sept 20-22 – New Orleans, LA
AARP, Sept 20-23 – New Orleans, LA
US Conference on AIDS, Sept 29- Oct 3 – Las Vegas, NV
Hispanic Association of Colleges and Universities, Oct 20-22 – New Orleans, LA
American Public Health Association, Oct 27-31 – San Francisco, CA
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