AN OPEN LETTER TO THE FDA ON MORCELLATION FOR PRESUMED UTERINE FIBROIDS
On December 8, 2015, 46 minimally invasive surgeons, gynecologic oncologists, and other experts spoke out in unison when they sent an open letter to the US Food and Drug Administration (FDA). They called into question the FDA’s estimate of the likelihood of occult leiomyosarcoma (LMS) and recommended continued use of power morcellation in appropriate cases.
An excerpt from this letter is published here. To read the letter in its entirety and the names of the signees, click here.
Letter excerpt:
If abdominal hysterectomy is recommended to women with fibroids, will women be better off?
By focusing exclusively on the risk of LMS, the FDA failed to take into account other risks associated with surgery. Laparoscopic surgery uses small incisions, is performed as an outpatient procedure (or overnight stay), has a faster recovery (2 weeks vs 4–6 weeks for open surgery), and is associated with lower mortality and fewer complications. These benefits of minimally invasive surgery are now well established in gynecologic and general surgery.
Using published best-evidence data, a recent decision analysis1 showed that, comparing 100,000 women undergoing laparoscopic hysterectomy with 100,000 undergoing open hysterectomy, the group undergoing laparoscopic surgery would experience 20 fewer perioperative deaths, 150 fewer pulmonary or venous embolus, and 4,800 fewer wound infections. Importantly, women having open surgery would have 8,000 fewer quality-of-life years.
A recently published study2 found that, in the 8 months following the FDA safety communication, utilization of laparoscopic hysterectomies decreased by 4.1% (P = .005), and abdominal and vaginal hysterectomies increased by 1.7% (P = .112) and 2.4% (P = .012), respectively. Major surgical complications (not including blood transfusions) increased from 2.2% to 2.8% (P = .015), and the rate of hospital readmission within 30 days also increased from 3.4% to 4.2% (P = .025). These observations merit consideration as women weigh the pros and cons of minimally invasive surgery with morcellation versus open surgery.
Clinical recommendations
Recent attention to surgical options for women with uterine leiomyomas and the risk of an occult LMS are positive developments in that the gynecologic community is reexamining relevant issues. We respectfully suggest that the following clinical recommendations be considered:
- The risk of LMS is higher in older postmenopausal women; greater caution should be exercised prior to recommending morcellation procedures for these women.
- Preoperative consideration of LMS is important. Women aged 35 years and older with irregular uterine bleeding and presumed fibroids should have an endometrial biopsy, which occasionally may detect LMS prior to surgery. Women should have normal results of cervical cancer screening.
- Ultrasound or MRI findings of a large irregular vascular mass, often with irregular anechoic (cystic) areas reflecting necrosis, may cause suspicion of LMS.
- Women wishing minimally invasive procedures with morcellation, including scalpel morcellation via the vagina or mini-laparotomy, or power morcellation using laparoscopic guidance, should understand the potential risk of decreased survival should LMS be present. Open procedures should be offered to all women who are considering minimally invasive procedures for “fibroids.”
- Following morcellation, careful inspection for tissue fragments should be undertaken and copious irrigation of the pelvic and abdominal cavities should be performed to minimize the risk of retained
tissue. - Further investigations of a means to identify LMS preoperatively should be supported. Likewise, investigation into the biology of LMS should be funded to better understand the propensity of tissue fragments or cells to implant and grow. With that knowledge, minimally invasive procedures could be avoided for women with LMS and women choosing minimally invasive surgery could be reassured that they do not have LMS.
Respecting women who suffer from LMS, we conclude that the FDA directive was based on a misleading analysis. Consequently, more accurate estimates regarding the prevalence of LMS among women having surgery for fibroids should be issued. Women have a right to self determination. Modification of the FDA’s current restrictive guidance regarding power morcellation would empower each woman to consider the pertinent issues and have the freedom to undertake shared decision making with her surgeon in order to select the procedure that is most appropriate for her.
References
1. Siedhoff MT, Wheeler SB, Rutstein SE, et al. Laparoscopic hysterectomy with morcellation vs abdominal hysterectomy for presumed fibroid tumors in premenopausal women: a decision analysis. Am J Obstet Gynecol. 2015;212(5):591.e1–e8.
2. Harris JA, Swenson CW, Uppal S, et al. Practice patterns and postoperative complications before and after Food and Drug Administration Safety Communication on power morcellation [published online ahead of print August 24, 2015]. Am J Obstet Gynecol. doi:10.1016/j.ajog.2015.08.047.
