New Safety Concerns Regarding Uterine Tissue Spread

As laparoscopic surgeries have increased in popularity due to their minimally invasive nature and faster recovery times compared to open surgeries, so too has the use of laparoscopic power morcellators. These devices are used to cut up and remove tissue through small incisions during laparoscopic procedures such as hysterectomies and myomectomies. However, recent studies have revealed troubling risks related to the spread of unintended tissue when using power morcellators.

Risk of Uncontained Tissue Spread

Research has found that in a small percentage of women undergoing minimally invasive gynecologic procedures using power morcellators, there is a risk that unsuspected uterine sarcomas or other types of cancer like endometrial stromal sarcoma could be spread to the abdominal cavity due to the Laparoscopic Power Morcellators process. If a woman has an undiagnosed uterine sarcoma, the power morcellator may cut the tissue into many pieces and disperse cancerous cells throughout the abdominal and pelvic cavity during surgery. This makes future treatment options more complex and reduces the chances of long-term survival.

While uterine sarcomas are rare, occurring in only about 1 in 1000 women who undergo a hysterectomy for diagnosis of fibroids or abnormal bleeding, they are more aggressive than common endometrial cancers. The currently available pre-operative tests like ultrasound and biopsy are not always effective at detecting these sarcomas before surgery. Therefore, some cancer specialists argue the use of power morcellators may be contraindicated as the risk of iatrogenic tumor cell dissemination outweighs the benefits of a minimally invasive procedure.

FDA Warning and Regulation

In response to these safety concerns, the U.S. Food and Drug Administration issued a warning in 2014 and restricted the use of power morcellators during laparoscopic hysterectomy or myomectomy for most women to only cases where the device was deemed necessary and there were appropriate discussion of risks with the patient. At the same time, several device manufacturers suspended sales and promotions of intra-abdominal power morcellators.

The FDA called for more comprehensive discussions between physicians and patients about the possibility of an undiagnosed uterine sarcoma and the risk of spreading tumoral tissue when using morcellators. However, the restriction was not a complete ban and surgeons could still use the devices where they were felt to be clinically warranted and patients understood the risks. Some gynecological societies opposed an outright morcellator ban, arguing it would eliminate the choice of minimally invasive procedures for many women.

Rise of Manual Morcellation

In response to the regulatory and liability issues surrounding power morcellation, more surgeons have adopted the use of manual or electric hand morcellation techniques as an alternative. This involves using surgical instruments to manually cut and remove tissues through the laparoscopic trocar sites without an power-driven morcellator. Proponents argue this eliminates the risk of iatrogenic tumor dissemination while still allowing for minimally invasive treatment in many cases.

However, manual morcellation is a more technically difficult process, especially when removing large fibroid tumors or uterine sizes. It generally takes longer to perform than power morcellation. Some studies have also found a higher conversion rate to open surgery may be required with manual techniques versus power morcellators. This negates some of the benefits of minimally invasive procedures like faster recovery. Device companies are also developing new single-use manual morcellators designed for improved safety.

Continued Debate Around Risks and Benefits

With no definitive pre-operative testing available to reliably rule out occult sarcomas, the debate around power morcellator risks versus benefits of minimally invasive gynecologic surgery continues in the medical community. Some argue a total ban is warranted given the often fatal consequences of iatrogenic tumor spread. Others believe restricting use to only when medically necessary with proper informed consent strikes the right balance. In the future, improved pre-surgical diagnostic tests may help clarify appropriate patient selection criteria. For now, the FDA warning has likely reduced power morcellator utilization in the U.S. but has not eliminated their role in minimally invasive procedures altogether.

New technologies are developed, future guidance from regulatory bodies and medical societies will further refine appropriate use and continue weighing the risks versus benefits of laparoscopic power morcellation. This important safety issue remains an active area of research, discussion and guidelines as the goal is minimizing unintended harm to patients while maximizing treatment options. The debate is likely to evolve as more data on long-term outcomes emerges in the years ahead. Patient and physician education on surgical options and their trade-offs will guide future practice patterns regarding these devices.

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