Medical Device Daily Contributing Writer

CHICAGO — It is not surprising that for a specialty recognized for its surgical expertise, innovative kits designed to further improve performance and shorten operating time continue to evolve at a rapid pace. That definitely was the case at the 29th annual meeting of the American Urogynecologic Society (AUGS; Washington), where second-generation surgical kits that supersede prior kits were launched, enabling less-invasive surgery to become even less invasive in procedures for incontinence and prolapse that have traditionally been regarded as technically challenging.

Single-incision mini-slings and transvaginal prolapse repair kits are positioning pelvic procedures to be office-based procedures in the future.

Granted, this might take five years or so to obtain long-term data and reimbursement for being performed in an office setting, but the technology demonstrated at this meeting has set the stage for this to occur; with the hope that by being performed in an office setting under minimal anesthesia, it will attract the hundreds of thousands of women who are currently forgoing these procedures.

It is estimated that 11% of American women will have surgery for pelvic organ prolapse (POP) sometime during their lifetime and that there will be 40 million women in the U.S. with POP by 2020. It also is predicted that 50% of all women who have children delivered vaginally will experience some form of prolapse later in life.

Given these numbers, it can be assumed that the more than 275,000 POP procedures performed annually in the U.S. are a mere tip of the iceberg. Until 2004, most surgeries for POP were technically challenging, had an unacceptable recurrence rate, and provided few devices to assist the surgeon.

Since then, Ethicon Women's Health and Urology (Somerville, New Jersey), American Medical Systems (AMS; Minnetonka, Minnesota), Caldera Medical (Agoura Hills, California), Boston Scientific (Natick, Massachusetts), Coloplast (Minneapolis), C.R. Bard (Murray Hill, New Jersey), MPATHY (Raynham, Massachusetts) and Endogun Medical Systems (Kibbutz Haogen, Israel) each have developed mesh and/or kits that assist the surgeon in performing POP procedures less invasively, in shorter time, and with drastically reduced recurrence rates.

In a presentation titled "One Year Anatomic and Functional Outcome after Reconstructive Surgery with Prolift Pelvic Floor Repair System," M. Alperin, MD, of the University of Pittsburgh analyzed pre- and post-op data on 40 women assessing objective and subjective outcomes after POP surgery using one such kit.

He said, "Anatomic support and functional outcomes at one year after surgery are promising with high patient satisfaction and an acceptable complication rate. Some 95% of the patients said that they would recommend the procedure to a friend."

Due to the high rate of failure with conventional vaginal prolapse repairs, many surgeons have turned to the use of transvaginal polypropylene mesh kits. However, as with any new procedure, trade-offs occur. It appears that the trade-off with using mesh in order to get a longer lasting — if not permanent — repair is that some patients experience pelvic pain and occasionally the mesh erodes the tissue surrounding it.

In order to reduce these side effects, second-generation mesh/kits were developed using either a lighter, softer mesh, smaller amounts of mesh, or totally transvaginal repair procedures involving less vulnerable tissue.

This shift to a totally transvaginal approach for POP parallels the development of "mini-slings" for stress urinary incontinence and sets up both procedures for an eventual shift into an office setting. There are many driving forces for making urogynecology procedures less invasive in addition to the improved effectiveness and quicker recovery for the patient.

Once these procedures are proven safe in an office setting, and once reimbursement is available to perform them in an office setting, it is felt that more patients will have these much-needed procedures performed. Since these conditions are not life threatening, albeit quality of life compromising, it is felt that the sheer inconvenience and fear of going into a hospital — along with the cost — has kept many patients untreated.

In addition, the time for travel to and from the hospital, along with OR turnover time, is unproductive and uncompensated time for the surgeon. The ability to perform these procedures in an office and get paid for them will be a win-win for both patient and surgeon and is expected to grow the market.