FDA takes immediate steps to help reduce risk of spreading unsuspected uterine cancer

The U.S. Food and Drug Administration (FDA) is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids, which is in keeping with Kalorama Information's view that in the female health market there is much room for improvement both in the development of products and the treatment of diseases. The FDA warns against using power morcellators – devices that divide tissue – in the removal of fibroids (myomectomy) or the uterus (hysterectomy). In gynecological practice, 3D and 4D ultrasound are now being used to detect structural problems of the uterus and diagnose ovarian tumors, endometrial polyps, and fibroids. The women's health arena, both therapeutics and diagnostics, has grown considerably as a specialty medical field. Once limited to obstetrics and gynecology, it now includes other fields, such as urology, maternal-fetal medicine, as well as autoimmune disease and cystic fibrosis. Kalorama's Women's Health Diagnostic Markets analyzes the current and potential world markets for key diagnostic tests targeted at women's health.

Uterine cancer is the most common cancer of the female reproductive organs among American women. The American Cancer Society estimates that about 52,630 new cases of cancer of the uterus will be diagnosed in the U.S. in 2014, with about 8,590 women dying from cancers of the uterine body. As uterine tissue may contain unsuspected cancer, the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.

Uterine cancer can often be cured, especially when diagnosed early. Generally and from a perspective on women's health, diagnostics are playing an ever increasing role. Diagnostic testing and screening have an impact on more than 70% of healthcare treatment decisions. They are the least expensive component of the healthcare system, comprising less than 5% of hospital costs and about 1.6% of all Medicare costs. The healthcare market researcher's report forecasts future market growth for diagnostic tests to 2018. Market segments covered include the U.S., Europe, China, Brazil, Japan and rest of world markets.

The FDA warns that laparoscopic power morcellators should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for removing tissue intact through the vagina or mini-laparotomy incision. Such morcellators should also not be used in gynecologic surgery in which the tissue to be divided is known or suspected to be cancerous.

Women's Health Diagnostic Markets reviews the nature and direction of research and trends, and gives insight into some issues facing the industry. The report profiles several key companies, including large companies that have made names for themselves in the field, as well as smaller firms with market niches. These companies are involved in developing and marketing over the counter (OTC), point of care (POC) in vitro diagnostic (IVD) tests and screening systems. Some of the companies profiled include:

  • GE Healthcare
  • GenMark Diagnostics
  • Hologic
  • Immco Diagnostics
  • Luminex
  • Nova Biomedical
  • Philips Healthcare
  • Siemens Healthcare
  • Somagen Diagnostics

Kalorama Information


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