In April 2014, the FDA announced in a safety alert that it wants to discourage the use of power morcellators. the problem is that some women may have undiagnosed uterine cancer which a morcellator can upstage, magnify, and make more dangerous, even deadly.
FDA warned on April 17, 2014:
“Based on an analysis of currently available data, the FDA has determined that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids have an unsuspected type of uterine cancer called uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
Risk of Power Morcellaton
Power morcellation is less invasive than traditional forms of surgery; but it also carries the risk of spreading benign or malignant tissue when used during myomectomies or hysterectomies for fibroid treatment or uterus removal.
Alternatives to Power Morcellation
The FDA acknowledged that power morcellators are less invasive (as advertised) than traditional approaches. They require fewer sutures; but nonetheless the FDA’s Obstetrics and Gynecology Devices Advisory Panel recommends that women seek, and that surgeons use, alternative methods. Several non-surgical treatments exist for fibroids, including expectant management, pharmaceutical therapy, uterine artery embolization, endometrial ablation.
Surgical Options for Fibroid Treatment
If a woman does require surgery, she and her doctor can decide between a hysterectomy, complete removal of the uterus; or a myomectomy, which targets only the fibroids. Many factors enter into this decision, including age, a (possible) desire for pregnancy, history of atypical cervical or endometrial cells, family history of cancer, risk of fibroids’ return.
Traditional Options: Hysterectomy & Myomectomy
The traditional option for removing the uterus is total abdominal hysterectomy, which the FDA says is the most common surgical choice. This involves a surgical incision in the wall of the lower abdomen, compared with laparoscopic hysterectomy, which takes less time and usually produces fewer urinary tract injuries.
Supracervical, or subtotal, hysterectomy and total vaginal hysterectomy are other options. According to the American College of Obstetricians and Gynecologists, vaginal hysterectomy is the most preferred option due to benefits it provides compared with alternatives. FDA says vaginal hysterectomy allows faster recovery and less of a chance of inducing infections than abdominal hysterectomy.
When fibroids are removed instead of the entire uterus, an open abdominal myomectomy is a traditional option. This involves an abdominal wall incision similar to an abdominal hysterectomy, and it precludes the need for morcellation.
Risks of Laparoscopic Treatment
According to FDA, compared with vaginal hysterectomy, the laparoscopic alternative may cause more complications during surgery, more transfusions, and a longer time spent in the operating room. Laparoscopic hysterectomy uses multiple small incisions in the abdomen wall along with gas and visualization instruments. It is during these types of procedures that surgeons often use power morcellators to allow large tissue to be extracted.
The types of laparoscopic hysterectomy include laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, and laparoscopic supracervical hysterectomy. Each of these types may, at some point during the procedure, require some form of morcellation to allow for complete uterine removal.
In minimally invasive laparoscopic myomectomy, power morcellation or the extending of incisions are ways of removing the cut fibroids. Morcellation may also be used during hysteroscopic myomectomy, a transvaginal procedure that does not require an abdominal incision, for fibroids found within the endometrial cavity and inner myometrium.
Alternative Surgical Techniques
To promote surgical techniques that mitigate the risks of power morcellation, various options have been suggested as possible ways to prevent spreading of tissue while maintaining the claimed benefits of minimally invasive procedures.
En-bloc resection techniques remove tissue completely intact, hoping to avoid power morcellation and the risk of spreading tissue pieces. To that end, methods could be used such as minilaparotomy, a surgically enlarged ancillary port; or transvaginal extraction. Each of those procedures comes with its own set of potential complications, however, and it is unclear whether any alleviate the risk of tissue dissemination.
Containment Bags and Other Strategies
Some industry representatives argue that leaving power morcellators on the market will drive companies to find new solutions to mitigate their risks. Proposed methods include vaginal morcellation and transvaginal extraction. Most common are techniques that involve containment bags.
Morcellator Options for Fibroids
Techniques in “bag morcellation” have been floated as a means of reducing the risk of spreading (potentially) cancerous tissue. But after the FDA examined the limited data for the permeability, integrity, and ability to execute various morcellation techniques within various surgical bags and other “containment strategies,” the agency could not verify the efficacy of any of those methods for reducing the morbid and cancer-spreading risks of power morcellators.