Menorrhagia: An untapped market
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More than 550,000 American women had a hysterectomy last year, making it the most common medical procedure performed on women in the U.S., excluding hospital deliveries. Many women have hysterectomies because of excessive uterine bleeding, or menorrhagia. However, for many women with menorrhagia, hysterectomy is unnecessary. Approximately 50 percent of hysterectomies are conducted because women experience hormonal imbalances, fibroids, or polyps, which result in excessive bleeding or menorrhagia. Many pre-menopausal women who endure menorrhagia, are pursuing options which will allow them to continue bearing children after surgical treatment. Finally, a vast majority of women are interested in less-invasive procedures. Thus, it is becoming evident that further research and development is needed to meet the growing demand for treatment options.
Conventional Therapies
Excessive menstrual bleeding, also known as menorrhagia, is caused by the shedding of uterus lining or endometrium. Below is a brief analysis of the traditional treatments for this problem:- Drug and hormone: Uses non-steroidal anti-inflammatory drugs to reduce menstrual blood loss between 25 and 35 percent. Oral contraceptives can reduce bleeding by 50 to 80 percent.
- Dilation and Curettage (D&C): Involves scraping away or vacuum aspiration of uterine contents.
- Myomectomy: Cuts fibroids out of the wall of the uterus surgically.
- Transcervical Resection of the Endometrium (TCRE): Uses a resectoscope (a cutting instrument), which features a heated, looped wire to destroy endometrial tissue.
- Hysterectomy: Removes uterus through a highly invasive procedure, which requires general anesthesia.
Uterine Artery Embolization (UAE)
Uterine artery embolization is used to shrink fibroids, which account for approximately 30 percent of hysterectomies in the United States. While embolization has been used for several decades to treat other parts of the body, it is a relatively new application within the uterus. UAE has been used in Europe for approximately eight years. However, it is currently an investigational procedure in the United States.When a patient undergoes UAE, a radiologists inserts a catheter into her femoral artery. The catheter is guided toward the uterine artery, where tiny plastic particles are injected to block the blood vessels feeding the fibroids. Fibroids begin to shrink between 40 to 60 percent within weeks or months.
Cryoablation
Cryoablation uses extremely cold temperatures to ablate or destroy endometrial tissue, which may be the source of many women's bleeding problems. An ultra-thin cryogenic probe is inserted into the uterine cavity through the vagina and cervix. The temperatures at the tip of the probe are then lowered, and a "freeze cycle" of uterine tissue ensues. One side of the uterus receives a four-minute freeze, and the other side receives a six-minute freeze.Uterine Balloon Therapy
Uterine Balloon Therapy (UBT) is used in a simple outpatient procedure to reduce excessive menstrual bleeding. Under local anesthesia, a balloon catheter is inserted through the cervix and into the uterus. The balloon connects to a catheter, which leads to a central control unit. The deflated balloon is placed inside the uterus, and the control unit pumps saline into the balloon. A heating element inside the balloon is activated and warms the solution to approximately 87C. The solution becomes hot enough to scald away the endometrial lining during the eight minutes required for ablation.Microwave Endometrial Ablation
MEA is performed by using a hand-held microwave applicator. The microwave energy is designed to provide quick and accurate heat to destroy the endometrium. Before the procedure, patients must take a course of prescribed hormonal drugs to thin their endometrium lining. MEA is a relatively short surgical procedure, requiring a short hospital stay. Patients are able to recover relatively quickly. Currently, Microsulis is the only company in Phase III clinical trials in the U.S. The company hopes to release its MEA device into the market in the near future.Light-based Therapy
One treatment option for menorrhagia currently being tested in the United States and Canada is GyneLase Endometrial Laser Intrauterine Thermal Therapy (ELITT). ELITT is an experimental ablation procedure, which uses GyneLase laser light to treat the endometrium. This procedure does not require general anesthesia or hospital stay, and only takes seven minutes to perform.Chart 1 provides an evaluation of treatment times, success rates, pros, and cons for each of the minimally-invasive procedures discussed in this article. Treatment options used depend on the needs of the patient and the skill of her physician.
An Untapped Market
Approximately 2.4 million American women suffer from menorrhagia, limiting a woman's ability to work, exercise, or even leave the vicinity of a bathroom. Though menorrhagia has affected women for ages, only now is it becoming apparent how restrictive and debilitating this problem is. While new treatment devices and procedures offer women more options than before, it is evident that further progress is necessary to address the needs of those with menorrhagia in the United States. The majority of treatments described in this article have been specifically approved for women who have completed bearing children or do not plan on becoming pregnant. As a result, pre-menopausal women, who desire to bear children, continue to live with the discomfort and pain of menorrhagia. There is great demand for procedures or treatment options, that are:Source: Frost & Sullivan
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