The issue continues to be, for some, that the simple technique of removing laparoscopic fibroids with help of electrical morcellator may become much more serious given the existence of undetected cancer. Power morcellation fostered the spreading of undetected cancer. Thats what went down to anesthesiologist Amy Reed. Based on the Philadelphia Inquirer (4/19/14), Reed underwent fibroid removal along with a hysterectomy in Boston, and soon after developed stage-four leiomyoscarcoma. The aggressive cancer has since required Reed to undergo extensive surgery and five of the expected six rounds of chemotherapy so that they can eradicate cancer in the 40-year-old mother of six. Reeds husband, cardiothoracic surgeon Hooman Noorchashm, noted in comments posted there was no evidence that the cancer had spread prior to the laparoscopic power morcellation hysterectomy.
Power morcellation is really a procedure whereby a specialized tool is inserted via a small incision along with a rotating tip cuts away fibroids and fibrous tissue from inside. The problem, say critics, is that the procedure has the potential to spray cancerous cells which had thus far been confined, out to a wider area where they could further spread. Noorchashm told the Inquirer there had been no proof of the spread of cancer before the power morcellation procedure. Based on the FDA, an analysis determined that one in 350 women who undergo a hysterectomy or laparoscopic power morcellation myomectomy for that removal of what are thought to be fibroids, are not even aware they carry a uterine sarcoma. Thus, the process active in the sectioning of fibroids without attempting to contain errant fibroids and cells, has got the possibility of further spreading of cancer to the abdominal cavity from within.
The laparoscopic power morcellator is a surgical device used to remove uterine fibroids during a minimally invasive surgery known as laparoscopic hysterectomy. However, the use of laparoscopic power morcellators has been linked to the spread of undiagnosed cancer cells in women, leading to a suspension of its sale by the US Food and Drug Administration (FDA) in 2014. In this essay, we will explore the history of the laparoscopic power morcellator, the concerns that led to its suspension, and its current status in the market.
History of the Laparoscopic Power Morcellator
The laparoscopic power morcellator was introduced in the 1990s as a surgical device used to remove uterine fibroids during laparoscopic hysterectomy. The device consists of a long, slender tube with a cutting blade at the end, which is used to chop up the fibroids into small pieces that can be easily removed through small incisions. The use of laparoscopic power morcellators was seen as a less invasive alternative to traditional open surgery, which required a larger incision and longer recovery time.
Concerns Leading to the Suspension of the Sale of Laparoscopic Power Morcellators
In 2013, concerns were raised about the potential risk of using laparoscopic power morcellators in women with undiagnosed uterine cancer. Studies suggested that the use of laparoscopic power morcellators could spread cancer cells throughout the body, leading to the development of advanced cancer and reducing the chances of survival for these women. The concern was that the laparoscopic power morcellator could potentially break up undiagnosed cancerous tissue during the surgery, which could then be spread throughout the abdominal cavity.
In April 2014, the FDA issued a safety communication warning against the use of laparoscopic power morcellators in the removal of uterine fibroids. The warning advised healthcare providers to carefully consider the risks and benefits of using laparoscopic power morcellators in each patient, particularly in women who were at an increased risk of having undiagnosed uterine cancer.
In July 2014, the FDA issued a second communication, stating that it had not found a way to adequately reduce the risk of spreading cancer cells during the use of laparoscopic power morcellators. As a result, the FDA issued a recommendation that the sale and distribution of laparoscopic power morcellators be suspended until further research could be conducted.
Current Status of the Sale of Laparoscopic Power Morcellators
The suspension of the sale of laparoscopic power morcellators by the FDA has had a significant impact on the market for these devices. The suspension has led to a decline in the use of laparoscopic power morcellators in surgical procedures and has resulted in increased demand for alternative methods of removing uterine fibroids.
In 2018, the FDA announced that it had granted marketing clearance to a new device called the Acessa System, which uses radiofrequency energy to remove uterine fibroids. The Acessa System is seen as a less invasive alternative to laparoscopic power morcellators and is expected to become a popular option for surgeons and patients alike.
In addition to the Acessa System, there are several other alternative methods of removing uterine fibroids, including traditional open surgery, hysteroscopic surgery, and uterine artery embolization. These methods do not pose the same risk of spreading cancer cells as laparoscopic power morcellators and are thus seen as safer alternatives.
Conclusion
The suspension of the sale of laparoscopic power morcellators by the FDA in 2014 was a significant event in the field of gynecologic surgery. The concerns raised about the potential risk of spreading undiagnosed cancer cells during the use of laparoscopic power morcellators led to a decline in their use and an increased demand for alternative methods of removing uterine fibroids. The Acessa System and other alternative methods of removing uterine fibroids are seen as safer alternatives to laparoscopic power morcellators, and they are likely to become more popular in the future.
While the suspension of the sale of laparoscopic power morcellators has had a significant impact on the market for these devices, it has also highlighted the need for greater regulation and oversight in the medical device industry. The concerns raised about the potential risk of using laparoscopic power morcellators in women with undiagnosed uterine cancer illustrate the importance of conducting thorough research and testing before bringing medical devices to market.
Moving forward, it is likely that we will see more rigorous testing and regulation of medical devices to ensure their safety and efficacy. The suspension of the sale of laparoscopic power morcellators has brought attention to the need for greater transparency and accountability in the medical device industry, and it is likely that we will see changes in the way that medical devices are tested and approved in the future.
In conclusion, the suspension of the sale of laparoscopic power morcellators by the FDA in 2014 was a significant event that has had a lasting impact on the field of gynecologic surgery. While the use of laparoscopic power morcellators has declined, alternative methods of removing uterine fibroids have emerged that are seen as safer and more effective. The suspension of the sale of laparoscopic power morcellators has also highlighted the need for greater regulation and oversight in the medical device industry, and it is likely that we will see changes in the way that medical devices are tested and approved in the future.
