Page 2 - Journal of Laparoscopic Surgery - WALS Journal
P. 2

Editorial




                Since the beginning, larger surgical incisions were an absolute necessity to a successful procedure
                and specially for tissue retrieval. Exposure was the key to a safe and successful tissue retrieval
                without contaminating the abdominal wound. Minimal Access Surgery is growing fast but it is
                facing many ups and down with important instruments. Power morcellation is one of the useful
                instrument used by laparoscopic surgeons and gynecologists which has given the capacity to
                perform fibroid removal and supracervical hysterectomy through a small incision.
                   However, in recent years, several plaintiffs have alleged they emerged from a morcellation
                procedure with a cancer diagnosis when no risk factors were present prior. Based on an FDA
                analysis of currently available data, FDA state that approximately 1 in 350 women undergoing hysterectomy or
                myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer
                that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman
                with fibroids may have a uterine sarcoma.
                   Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against
                the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for
                treatment of fibroids.
                   Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spread-
                ing unsuspected cancer, and the recommendation that Minimal Access Surgeon share this information directly with
                their patients, are part of FDA guidance to manufacturers of morcellators.
                   Since the FDA warning, Johnson & Johnson pulled the device called a laparoscopic power morcellator from the
                market; many hospitals. But a group of gynecologist believe that the risks of unknown cancer have been overblown
                and the government should not interfere with patient treatment. The number of gynecologists still employing mor-
                cellators is difficult to estimate. According to many gynecologist it is skepticism that the FDA acted too quickly.
                Although morcellator can be used keeping inside a surgical bag, a controversial solution that some believe could
                prevent stray bits of tissue.
                   The American College of Obstetricians and Gynecologists argues that with more stringent patient selection, the
                device remains an important tool. Let us see what comes ultimately in guideline but in our opinion till new safe
                technique comes we should stop using power morcellator.
                                                                                                           RK Mishra
                                                                                                         Editor-in-Chief


































                                                                                                                    v
   1   2   3   4   5   6   7