FDA is announcing the availability of a guidance for industry and FDA staff entitled “Immediately in Effect Guidance Document: Product Labeling for Laparoscopic Power Morcellators.” This guidance is being implemented without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). FDA believes that immediate implementation of the guidance is needed to assist in addressing a significant public health issue. Although this guidance document is immediately in effect, FDA will consider all comments received and revise the guidance document when appropriate.
As the number of laparoscopic and minimally invasive procedures has increased through the introduction of new surgical technologies and techniques, additional safety information has become available regarding the use of LPMs. Recent discussions within the patient and clinical communities, as well as the peer-reviewed medical literature, have raised awareness of the risk of spreading unsuspected cancerous tissue beyond the uterus when LPMs are used during gynecologic surgeries intended to treat
benign fibroids. Numerous case reports and case series have been published that describe the iatrogenic dissemination, implantation, and subsequent growth of unsuspected neoplastic tissue within the peritoneal cavity following laparoscopic morcellation of uterine tissue believed to contain fibroids based on preoperative diagnosis.
FDA’s recent analysis of available information suggested that the risk of an occult uterine sarcoma in a woman undergoing surgical intervention for presumed fibroids is substantially higher than had previously been assumed or reported. FDA’s analysis also suggested that patient outcomes, including survival, may be significantly adversely impacted from this upstaging of disease. Patient selection and choice of surgical technique can reduce the risk of spreading cancer. Specifically, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit/risk profile of using LPMs is worse in peri- and post-menopausal women compared to pre-menopausal women. The surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging an occult sarcoma. Importantly, no screening procedure that can reliably detect sarcoma preoperatively has been identified.
FDA considers this new scientific information to represent a significant change to the benefit/risk profile for these devices, prompting the issuance of a Safety Communication on April 17, 2014 (Ref. 1), and convening of the FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on July 10-11, 2014 (Ref. 2), to further discuss the use and labeling of LPMs during gynecologic surgeries. FDA is issuing this document after considering the input of the Panel and other stakeholders, including comments made during the Open Public Hearing portion of the Panel meeting.
As a result of the new information and discussions during the public Advisory Committee meeting, FDA recommends that manufacturers of LPMs with a general indication or a specific gynecologic indication prominently include two specific Contraindications and a specific Boxed Warning in their product labeling. FDA believes this may be information that manufacturers should disclose to users under sections 201(n), 502(a), and 502(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n), 352(a) and 352(f)(2)). The issuance of this guidance represents another step in addressing this serious public health issue. In the future, additional safety communications, guidance, or rulemaking may be undertaken to further support the safe and effective use of LPMs.