BBI Contributing Writer
CHICAGO, Illinois – Abnormal uterine bleeding, incontinence and emergency contraception were some of the many diverse topics covered at this year's annual meeting of the American College of Obstetricians and Gynecologists (ACOG; Washington), held in Chicago's sprawling McCormick Place convention center in early May. Five years ago, these topics might not have even been discussed between patient and physician. Yet, with the aging of the baby boomers and their access to more medical information through the internet, this large, well-informed group has created a driving force for medicine to meet its demands to have a fuller, more satisfactory lifestyle. No longer does medicine just save lives – it must now also address the quality of life.
Abnormal or dysfunctional bleeding can be a crippling disease to a busy, active woman. Although approximately 200,000 hysterectomies are performed in the U.S. each year for this disorder, endometrial ablation may become the preferred minimally invasive alternative to hysterectomy. It also is conceivable that women may request this procedure merely for cosmetic reasons (i.e., elimination of monthly periods), even though it is doubtful that any company would offer amenorhea as a reason for the procedure. However, whether it is for clinical or cosmetic reasons, until there is widespread awareness of endometrial ablation among both patients and physicians, it remains to be seen how popular it becomes.
Endometrial ablation for dysfunctional bleeding was highlighted at the ACOG gathering due to recent FDA approvals for products from BEI Medical Systems (Teterboro, New Jersey) and Cryogen (San Diego, California), as well as the introduction of an improved model from Johnson & Johnson's (New Brunswick, New Jersey) Gynecare division. ACOG exhibitor guidelines did not allow the other companies that are developing endometrial ablation products (see Table 1) to show any product not already FDA-approved.
|Table 1-Companies with Endometrial Ablation Products|
|$8,000-$9,000/$650||Approved 1997||Pretreatment required, simple to
learn, limited to normal uterine
|$10,500/$525||Approved April 2001||Reaches all surfaces of uterus,
regardless of cavity size and
shape; has direct visual guidance.
|Cryosurgery||$28,000/$650||Approved April 2001||Ultrasound required for therapy
($200 per use)
|In Europe since 1996;
in clinicals in U.S.
|Large (8.55 mm) probe.|
|Bipolar RF mesh
|$7,500/$800||Filed PMA 2/01,
ed Q301; CE mark
and Canadian ap-
|Suction keeps tissue in contact
with electrode; no pretreatment
required. Possibly quicker. Perfo
ration detection, but no visualiza
|$40,000/$400||In Europe now; in
Phase III clinicals
|No visualization. Results obtain-
ed from single investigator.
|Catheter with hot
|$10,000/$600||Sold in Europe||J&J me-too product. No visualizat-
Although each of the products/technologies listed in Table 1 have specific advantages and disadvantages, time will tell which one gains the most market share. Odds are that the product that is the most efficient, least expensive, easiest to use and least painful for the patient will win the race to market share. Getting physicians to offer them to their patients is the first hurdle. Many gynecologists feel that women with chronic bleeding just want their uterus out and "be done with it." But each potential candidate should be offered all available alternatives. According to Keith Isaacson, MD, consultant for Karl Storz Endoscopy (Culver City, California), "Lack of experience with the highest-quality endometrial ablation technique is not a sufficient rationale for offering a patient a different (i.e., hysterectomy) procedure."
Incontinence, another once little-discussed malady, is no longer being viewed as an inconvenience not worthy of medical help. According to a 1999 survey of 130,000 members of the National Association for Continence (NAFC), twice as many people sought the help of a health care professional for incontinence than did so just three years earlier. In addition, the level of consumer dissatisfaction with current treatments for incontinence is climbing. Six years ago, 34.6% of respondents registered dissatisfaction with treatment outcome. This year the dissatisfaction has climbed to 63.9%. These facts indicate the growing need for less-invasive and improved treatments for incontinence.
PelviCare (Laguna Hills, California) is developing a new generation of technologies, designed for "disease management" of incontinence and pelvic support problems with a continuum of conservative to surgical therapies. Its first product is designed to assist surgeons in proper positioning of a sling. The Accuset Sensor & Monitor, which has received 510(k) approval, is a disposable balloon with a pressure sensor and disposable monitor that is the first device that objectively quantifies the position of the urethra during a sling procedure.
Sling procedures (about 150,000 are done in the U.S. annually) are acknowledged as the most durable surgical technique for restoring continence in patients with stress urinary incontinence. The main resistance to increased penetration of the potential sling surgery market of more than 1 million surgical candidates has been the variation in outcomes associated with sling surgery. Until Accuset, the most common method of determining whether the sling was at the correct position was to insert a Q-tip into the urethra and adjust the sling until the Q-tip was at a zero degree angle. With Accuset, a numerical value will be established so that every surgeon can more accurately and consistently perform any sling procedure and with any sling material.
Although the success rates for incontinence surgery are climbing each year, the best rates at five years are still only 80% to 96%, with high variability. This is largely due to varying surgeon techniques, but could be greatly improved with a standard measurement of urethral angle. The Accuset device will help surgeons avoid the two major complications: obstruction and instability resulting from incorrect positioning of the sling. With a reduction in side effects and increase in surgical simplicity, the market for sling surgery could be expected to grow more rapidly.
A new minimally invasive product enabling surgeons to perform more sling procedures is TVT, or Tension-free Vaginal Tape, from Gynecare, a division of J&J's Ethicon (Somerville, New Jersey) unit. TVT is a non-absorbable polypropylene mesh that is surgically positioned close to the high-pressure zone of the urethra, that places no increased tension on the vaginal wall and no elevation of the urethra. It uses a Velcro-like surface to alleviate knot-tying, and the proper tension is determined by having the patient cough during the procedure to check for leaking. The patient must be under only a local anesthetic or very light sedation so that the patient can co-operate with the surgeon during the procedure.
Another innovative approach to stress urinary incontinence is that of using radiofrequency (RF) energy to shrink the endopelvic fascia which results in lifting the bladder neck and urethra without the use of implantable materials. In a study sponsored by SURx (Pleasanton, California), Donald Galen, MD, of the Reproductive Science Center of the San Francisco Bay Area (San Ramon, California), reported at the ACOG meeting on 94 patients he treated with RF energy and followed for 12 months. Success rates were over 80% at all follow-up periods, demonstrating that RF treatment of the endopelvic fascia for stress incontinence has a high success rate without the use of implants. SURx plans to develop RF energy products for incontinence treatments in all three market sectors: open surgery, laparoscopic surgery and noninvasive transvaginal therapy.
The newest entrant using RF energy to treat incontinence is Novasys Medical (Sunnyvale, CA), a privately held, venture capital-backed company. Novasys has developed a noninvasive, simple system using an RF generator and proprietary single-use RF energy delivery catheters. The objective is to offer an outpatient procedure with no incision and a rapid treatment time.
During the Chicago meeting, ACOG issued a call to action to the nation's 40,000 ob-gyns, asking them to help cut the rate of unintended pregnancy and abortion by offering an advance prescription for emergency contraception during women's routine annual visits. A combination of birth control pills can help prevent pregnancy if taken within 72 hours of unprotected sex. It prevents ovulation, fertilization, or implantation of the egg in the uterus. The most frequently used prepackaged emergency contraception pills are a combination of estrogen and progestin – Preven, by Gynetics (Somerville, New Jersey) – or consist of progestin only – Plan B, by Women's Capital (Bellevue, Washington).