Medical Device Daily Contributing Writer
WASHINGTON — A change in name, from the American Association of Laparoscopic Gynecologists (Cyprus, California) to simply the AAGL, unveiled at the recent 36th Global Congress of Minimally Invasive Gynecology here, may be taken as suggesting the theme of greater simplicity.
That theme was continually underlined in the clinical presentations, hallway discussions and exhibitor demonstrations for a wide variety of procedures that treat female pelvic conditions with a minimally invasive approach.
Pelvic floor procedures, which include both stress urinary incontinence (SUI) and pelvic organ prolapse (POP), number around 400,000 annually in the U.S. And yet it is believed that this is just a fraction of the women who could benefit from these treatments. Once an open challenging surgery, these procedures can now be performed laparoscopically with many enabling devices, and many less-invasive procedures have been developed for some of the conditions.
Of the 400,000 pelvic floor procedures, about 25% use a kit (often including mesh), with another 15% to 20% using mesh or sutures alone to augment the surgery, according to industry estimates.
Initial reports on the use of mesh or sutures to augment the surgery have claimed up to a 40% failure rate, with one of the reasons being mesh erosion.
To a standing-room-only audience, an expert panel chaired by Edward Stanford, MD, director of the Center for Advanced Pelvic Surgery (Centralia, Illinois), discussed the topic “Mesh Erosion — How do we Minimize Risk?”
Stanford began by asking, “How are pelvic surgeons managing prolapse and incontinence?”
He replied: “Depending on the degree of prolapse or incontinence, there are various surgical approaches, some of which utilize a mesh or kit” (see Table 1 below).
According to a Millennium Research report, about 268,000 pelvic floor reconstruction procedures were performed in 2005, of which only 42,800 used commercial products. The predicted growth rate of using synthetic grafts from 2005 to 2008 is 22.5%. It is forecast to be 17.7% for xenografts, and almost 12% for allografts for the same time period.
The growth of these minimally invasive pelvic procedures is being fueled by the number and types of grafts available (see Table 2 below), as well as by a better understanding of how the various grafts behave in the body and what are the best surgical approaches.
“Synthetic grafts were tried in the 1920s and were re-visited again in the 1940s - both times having erosion problems,” Stanford said. “We did not know the science of materials. We still don’t have the perfect material, but we know what to look for: [a material] that is lightweight, has larger pores and has low rigidity.”
“Surgical technique also helps reduce erosion rates,” said Dennis Miller, MD, director of Milwaukee Urogynecology at Wheaton Franciscan Healthcare (Wauwatosa, Wisconsin), in his presentation “Surgical Techniques to Minimize Erosions.”
He emphasized Stanford’s point that there is “no fascia in the vagina, and so dissection is critical to the success of these procedures.”
Miller said that there is evidence “that erosion rates increase when mesh is used during a concomitant procedure, such as when a hysterectomy is being performed, along with graft placement for pelvic organ prolapse. In fact, the expected erosion rate can be tripled in these cases.”
He advocated that the surgeon should “preserve the uterus, preserve erosion,” a mantra that was echoed throughout this meeting of minimally invasive gynecologists.
“Is surgeon experience another variable that can help reduce erosions?” Miller asked.
He quoted a recent study in which 198 prolapse patients were all given the same mesh in the same type of procedure by the same surgeon over a three-year trial period. The erosion rates decreased from 19% to 4% by the third year, thus answering the question and demonstrating that experience does count.
He concluded by saying that the erosion rates of 2002-2003 were higher than most seen today, a comforting statistic.
Although not covered by this panel, another great boost to performing intricate, minimally invasive surgeries is the advancement of laparoscopic instrumentation that can articulate 360% along with the human wrist.
Initially available only on the Da Vinci robot from Intuitive Surgical (Sunnyvale, California), most gynecologists have not had access to robotic technology until recently.
In the interim, three new companies have developed hand-held articulated laparoscopic instruments that behave in much the same fashion as those employed by the robot, but utilized independent of a robot in the same manor as handheld laparoscopic instruments. Novarre Surgical Systems (Cupertino, California) was showing its array of RealHand High Dexterity instruments that included graspers, dissectors, needle drivers, and soon (in December) scissors and Thermaseal, the company’s tissue welder.
Cambridge Endo (Framingham, Massachusetts) has similarly developed articulated handheld laparoscopic instruments that are even smaller than the robot at 5 mm, compared to 8 mm, in order to better reach those very small spaces generally featured in female pelvic anatomy.
Cambridge Endo currently is offering cutting and cauterizing scissors, electrosurgery hooks, and dissectors. Like the robot, its instruments can employ a scaling device that eliminates tremor.
The other participant in this space, but not present at the AGL conference, is Power Medical Interventions (Langhorne, Pennsylvania) whose initial product was an articulated power-controlled suturing device. Power Medical has since developed scissors and other product line extensions.
These new technologies enable the gynecologic surgeon to be able to improve on their already minimally invasive procedures for women’s pelvic health.
Editor’s note: The 1st story of this two-part series ran in the Nov. 21 issue of MDD.