October is a very important month for women: It’s National Breast Cancer Awareness Month. There are many things to be proud of for how far we have come with treating breast cancer. The Susan G. Komen Foundation reports that the 5-year survival rate for female breast cancer survivors in the U.S. has improved from 63% in the early 1960’s to 90% today. Thanks to advances in technology and awareness of the disease, we have been able to make great strides.

Recently, a few articles have rolled through my e-mail that caught my attention, and in the spirit of bringing attention to women’s health issues, I’ll share a few with you before October ends.

  • Hip Resurfacing Unsuitable for Women, Study Finds – The title says it all... researchers have uncovered that metal-on-metal hip resurfacing proves to have high failure rates in women.
  • Stenting outcomes worse for elderly women than men – This article discusses that risk of mortality in women is higher than in men after stent placement. Clinically, one-third of all procedures are conducted in women. However, the article suggests that this may not necessarily mesh with the ratio of women in stent manufacturer’s clinical trials.
  • Woman sues over medical device – A woman in Canada is suing Covidien over transvaginal mesh that was implanted in her 10 years ago. The mesh, which was originally approved for use in hernia surgeries, has been adopted for use for pelvic and uterine insertions. However, no testing has ever been performed for the safety of this indication, and now, many women are suffering severe health consequences.

These articles show some of the challenges that still lie ahead of us for women’s health. Recently, there was a draft guidance published by the FDA which highlighted the need for women to be included in representative numbers in clinical studies, and also that gender specific outcomes should be analyzed. Gathering information from a representative patient population will help make data more realistic and help uncover any risks before they result in patient harm. This is a step in the right direction for women’s health products, which have been under high scrutiny lately.

Women play an important role in the med tech/biotech industry, not only as patients, but as professionals too. Pittsburgh is launching their own Women in Bio chapter with an event next Tuesday October 30 – if you want to get involved with other women professionals in the area, be sure to attend!

- Sherri

Link: Draft Guidance for Industry and Food and Drug Administration Staff – Evaluation of Sex Differences in Medical Device Clinical Studies

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