EL SEGUNDO, CA (March 23, 2009) – KARL STORZ Endoscopy-America, Inc., a world leader in diagnostic and operative endoscopic technologies, announces that it will begin marketing its Neovagina Surgery Set and Accessories for minimally invasive treatment of vaginal agenesis in female patients. The instrument set is used in conjunction with a laparoscopic surgical technique that creates and enlarges the vaginal cavity.
Vaginal agenesis, or an absence of a vagina, is a congenital disorder that affects approximately one in every 5,000 female infants. The syndrome is also known as Mayer-Rokitansky-Kuester-Hauser Syndrome (MRKH). Although the cause of the disorder is unknown, it occurs when formation of the vagina and the uterus stops during fetal development. In MRKH, the length of the vagina may range from slightly shortened to virtually absent, consisting only of a small dimple on the skin. Most, though not all, patients are treated in their late teens to early 20s. Although the treatment is not urgent, it is generally necessary before sexual intercourse is possible. MRKH syndrome is one of the most common causes of primary amenorrhea (i.e., absent menses) in a young woman. It is important that women with primary amenorrhea undergo the appropriate diagnostic work-up to determine the cause of lack of menstruation. This includes a thorough medical history, review of symptoms, physical examination and possibly imaging studies and/or diagnostic laparoscopy. A complete work-up is essential as MRKH has been misdiagnosed as imperforate hymen or primary ovarian failure and incorrectly treated as a result of the misdiagnosis.
The first attempt to treat vaginal agenesis should be non-surgical; vaginal dilators are typically used. Surgical intervention is needed when attempts to create a vagina with dilator therapy are unsuccessful. It is important to note that both non-surgical as well as surgical treatment for vaginal agenesis require long-term use (months) of vaginal dilators .
“The KARL STORZ Neovagina Instrument Set offers an endoscopically assisted surgical method for creating the vagina in female patients. The set was developed to offer an alternative minimally-invasive treatment for these patients,” says Cheryl Coffelt, Marketing Manager, Laparoscopic GYN, KARL STORZ. For women who have attempted but failed to create a vagina using vaginal dilators without surgery, laparoscopic creation of the neovagina, followed by a period of use of vaginal dilators (approximately 4-6 months in one study), makes it possible for women with vaginal agenesis to engage in vaginal intercourse.
The instrument set includes a pluggable, segmented “dummy” (a type of vaginal dilator) used for initial dilation, straight and curved thread guides for placing sutures, and a traction device for suture tightening. A set of graduated dilators is also included for use during post-operative care.
The surgical technique is performed under general anesthesia and involves progressive intra-abdominal stretching of the vaginal membrane. The plastic dummy is inserted into the vaginal dimple and has two threads attached to the end that goes inside the body. An endoscope with an attached camera for visualization is inserted into the abdomen. Under endoscopic visualization, the surgeon introduces two threads into the abdominal cavity from the dimple on the skin where the opening of the vagina should be. The two threads are then pulled back outside the abdominal wall on either side of the navel and are attached to the traction device directly below the navel. This device is used to pull the threads taut and is progressively tightened every day. The device exerts continuous pressure to gradually pull the dummy into the body, forming the new vagina within a few days. Following surgery, regular use of the post-operative dummy over some months is necessary to complete formation of the neovagina. “The Neovagina Instrument Set was developed by KARL STORZ in close collaboration with Dr. Sara Brucker of the University of Tuebingen,” Coffelt adds. “Through such associations, our company continues to demonstrate its high level of commitment to improving surgical solutions based on innovative minimally invasive techniques, regardless of the market size for a given procedure.”