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Balancing innovation and harm

Published:March 28, 2014DOI:https://doi.org/10.1016/j.ajog.2014.03.036
      See related articles, pages 418 and 486
      In an editorial in 2007, I questioned whether marketed vaginal mesh kits constituted “rampant experimentation or improved quality of care.”
      • Nygaard I.
      Marketed vaginal mesh kits: rampant experimentation or improved quality of care?.
      In the following years, mesh kits became used more widely, and complications became more evident. Surgeons were pitted against one another; media coverage proliferated, and class action lawsuits are ongoing. In July 2011, the Food and Drug Administration (FDA) issued a Safety Communication to inform the medical community and patients that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse were “not rare” and that it was unclear whether such surgeries were more effective than traditional nonmesh repairs.

      FDA Safety Communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Accessed March 11, 2014.

      Has innovative optimism once again outpaced pragmatism? We are in the midst of another storm within the gynecologic community: uterine morcellation during laparoscopic or robotic surgery. The launch and rise of power morcellators have many similarities to those of vaginal mesh kits: both were cleared by the FDA as a class II device, were marketed heavily by industry, and were adapted widely, despite the absence of research evidence. Both have flaws considered obvious—in retrospect. Yet, uncommon complications become apparent only after a technique is adapted widely.
      Different forces brought the issue to a head for the 2 technologies: for vaginal mesh kits, the force was an increasing number of women seeking treatment for complications, mainly mesh extrusions and pain. For uterine morcellation, the force was a couple, Dr Hooman Noorchashm and his wife, Dr Amy Reed, who underwent a robotic-assisted hysterectomy with a surprise finding of sarcoma upstaged from 1 to 4 by the intraoperative use of the morcellator. In Dr Noorchashm's view, “Morcellation is playing Russian roulette with a deadly outcome,” citing a risk of 1 in 400 of sarcoma in women undergoing surgery for fibroids.
      • Hampton T.
      Critics of fibroid removal procedure question risks it may pose for women with undetected uterine cancer.

      Women's health alert: deadly cancers of the uterus spread by gynecologists. Stop morcellating the uterus in minimally invasive and robot assisted hysterectomy and myomectomy. Change.org Inc. Available at: http://www.change.org/petitions/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy. Accessed March 10, 2014.

      Upstaging a sarcoma could decrease the 5-year survival of women from 60% for stage I to 15-22% for stages III-IV sarcoma.
      • Hampton T.
      Critics of fibroid removal procedure question risks it may pose for women with undetected uterine cancer.
      The couple launched a media campaign calling on an immediate moratorium on intracorporeal uterine morcellation and on all morcellation devices.

      Women's health alert: deadly cancers of the uterus spread by gynecologists. Stop morcellating the uterus in minimally invasive and robot assisted hysterectomy and myomectomy. Change.org Inc. Available at: http://www.change.org/petitions/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy. Accessed March 10, 2014.

      How have professional groups responded? In a position statement in December 2013, the Society of Gynecologic Oncology noted that “fewer than one out of 1000 women who undergo hysterectomy for leiomyomas will have an underlying malignancy,”

      Morcellation. Chicago, IL: Society of Gynecologic Oncology; 2013. Available at: https://www.sgo.org/newsroom/position-statements-2/morcellation. Accessed March 1, 2014.

      that it currently is not possible to diagnose sarcomas preoperatively, and that these malignancies carry poor prognoses even when specimens are removed intact. The statement concludes by emphasizing the importance of informed consent. In March, the AAGL, Advancing Minimally Invasive Gynecology Worldwide, updated its members that it is establishing a task force to review the scientific evidence and best practices regarding morcellation.

      AAGL member update: disseminated leiomyosarcoma with power morcellation (Update #2). Cypress, CA: AAGL, Advancing Minimally Invasive Gynecology Worldwide; 2014. Available at: https://www.aagl.org/aaglnews/member-update-disseminated-leiomyosarcoma-with-power-morcellation-update-2/. Accessed March 28, 2014.

      Although the recent media storm has focused on disseminating cancerous tissue throughout the abdomen, morcellation is not without other risks. In a review searching articles and the Manufacturer and User Facility Device Experience FDA device database from 1993-2014, Milad and Milad
      • Milad M.P.
      • Milad E.A.
      Laparoscopic morcellator-related complications.
      identified 55 complications, including 6 deaths attributed to morcellator-related complications. Without a clear denominator, it is difficult to put this risk into perspective. Reports are trickling in describing problems related to the dissemination of benign endometrial tissue. For example, the Images report in this month's issue demonstrates the diagnostic dilemma presented by dissemination of adenomyosis after robotic hysterectomy with morcellation.
      • Liu Y.
      Multiple distant adenomyosis mimicking carcinomatosis on FDG PET/CT.
      This issue raises several questions: How should new technologies be introduced and monitored? What is an acceptable level of risk? Who decides? It is well-known that physicians and patients, given the same information, perceive magnitude of risk differently. Further, if people perceive the risk of benefit to be high, they judge the risk of harm to be low and vice versa.
      • Alhakami A.S.
      • Slovic P.
      A psychological study of the inverse relationship between perceived risk and perceived benefit: risk analysis.
      The way in which health scenarios and risk information is presented affects how people evaluate such risks.
      • Timmermans D.R.
      • Ockhuysen-Vermey C.F.
      • Henneman L.
      Presenting health risk information in different formats: the effect on participants' cognitive and emotional evaluation and decisions.
      Slovic et al, noting that both rational and experiential systems are needed to guide decision-making, question, “On the one hand, how do we apply reason to temper the strong emotions engendered by some risk events? On the other hand, how do we infuse needed ‘doses of feeling’ into circumstances where lack of experience may otherwise leave us too ‘coldly rational’?”
      • Slovic P.
      • Finucane M.L.
      • Peters E.
      • MacGregor D.G.
      Risk as analysis and risk as feelings: some thoughts about affect, reason, risk, and rationality.
      Despite the fact that approximately 20,000 laparoscopic and robotic supracervical hysterectomies (techniques generally accompanied by intraabdominal power morcellation) are done each year in the United States, we do not know the true incidence of unexpected sarcoma during surgery for apparent benign uterine disease.
      • Kho K.A.
      • Nezhat C.H.
      Evaluating the risks of electric uterine morcellation.
      Population incidence rates may not apply to women who undergo surgery for fibroid tumors. Kho and Nezhat
      • Kho K.A.
      • Nezhat C.H.
      Evaluating the risks of electric uterine morcellation.
      summarized 7 case series that were published from 1983-2010 that together reported 13 unexpected uterine sarcomas in 5666 uterine procedures (with risks ranging from 0–0.49%).
      Currently, clinicians recommend that women with fibroid tumors undergo surgery to treat symptoms, not to diagnose and remove early potential sarcomas. The American College of Obstetricians and Gynecologists Practice bulletin notes, “If a comparison is made between the prevalence of leiomyosarcomas discovered incidentally (1/2000) and the mortality rate for hysterectomy for benign disease (1–1.6/1000 for premenopausal women), the decision to proceed to hysterectomy to find potential sarcomas should be made cautiously.”
      American College of Obstetricians and Gynecologists
      Alternatives to hysterectomy in the management of leiomyomas. ACOG Practice bulletin no. 96.
      Yet, this strategy relies on accurate data about the risk of cancer in fibroid tumors.
      What do we recommend now? The tide away from open abdominal hysterectomy has irrevocably turned. However, this does not mean that power morcellation is the only option available to treat women with fibroid tumors. Surgeons should prioritize vaginal hysterectomy (the original “natural orifice surgery”); morcellation, if needed, usually can occur in the vagina with the use of a scalpel, rather than a power-morcellator. However, we note that the assumption that this long-lived technique actually minimizes uterine tissue spread, to our knowledge, has not been examined rigorously. When fibroid size, location, or concomitant pelvic diseases create deterrents, vaginal extraction from a laparoscopic or robotic approach should be prioritized; in small groups of women, such a technique appears not to promote cancer spread in women who undergo operation for endometrial cancer.
      • Monella F.
      • Riboni F.
      • Cosma S.
      • et al.
      A safe method of vaginal longitudinal morcellation of bulky uterus with endometrial cancer in a bag at laparoscopy.
      • Favero G.
      • Anton C.
      • Silva e Sivla A.
      • et al.
      Vaginal morcellation: a new strategy for large gynecological malignant tumor extraction: a pilot study.
      Minilaparotomy to extract tissue should not be seen as a defeat to the principles of minimally invasive surgery. We question the burgeoning sentiment to perform in-bag morcellation, because the currently available devices may require surgeons to add a layer of complexity with which they may not be familiar, thus generating other problems from limited visibility to retained portions of the bag-to-bag breakage.
      In his thoughtful clinical opinion in this month's American Journal of Obstetrics and Gynecology that summarizes the debate over robotics in benign gynecologic surgery, Rardin
      • Rardin C.
      The debate over robotics in benign gynecology.
      notes that “the issue is not whether the robot has any role but rather to define the role in an institutional environment.” Similarly, the controversy over vaginal mesh led to defining more clearly its role in our surgical armamentarium such that its use is restricted to women in whom the potential benefit afforded by mesh augmentation is likely to outweigh the potential harm. Defining the role of both the robot and the instruments that are used to accomplish minimally invasive surgery is an important priority.
      We must become better “futurologists”—scientists who attempt to explore systematically predictions and possibilities about the future and how they can emerge from the present. Curiosity, creativity, and optimism, which are key attributes for successful surgeons, can also make it difficult for us to foresee downstream events.
      Surgeons, just as engineers, should consider new procedures and techniques from a risk management and design point of view. Consistent with the FDA's mandate on medical device development,

      FDA. 21 CFR Ch. 1 820.30, Subpart C-Design Controls. Washington, DC; Food and Drug Association; 2012. Available at: http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-sec820-30.pdf. Accessed March 11, 2014.

      surgeons should study all aspects of surgery, systematically identify and reduce risks, and integrate such study into evolving changes in surgical instruments and techniques.
      We fully support initiating a registry for all new technologies in our field, following the example of the Pelvic Floor Disorders Registry initiated by the American Urogynecologic Society with representatives of the FDA, Centers for Medicare and Medicaid Services, industry, and patients on the Stakeholder Advisory Board.

      Pelvic Floor Disorders Registry. Frequently asked questions. Washington, DC: American Urogynecologic Society; 2014. Available at: http://pfdregistry.augs.org/p/cm/ld/fid=440. Accessed March 11, 2014.

      Finally, we support patient-centered valuing of surgical risks and benefits and the development of shared decision-making tools and processes for interventions in our field.
      • Weinstein J.N.
      • Clay K.
      • Morgan T.S.
      Informed patient choice: patient-centered valuing of surgical risks and benefits.
      By encouraging evidence-based innovation while balancing harms and understanding how individual women value benefits and risks, we will find a sure way forward.

      References

        • Nygaard I.
        Marketed vaginal mesh kits: rampant experimentation or improved quality of care?.
        Int Urogynecol J Pelvic Floor Dysfunct. 2007; 18: 483-484
      1. FDA Safety Communication: UPDATE on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm. Accessed March 11, 2014.

        • Hampton T.
        Critics of fibroid removal procedure question risks it may pose for women with undetected uterine cancer.
        JAMA. 2014; 311: 891-893
      2. Women's health alert: deadly cancers of the uterus spread by gynecologists. Stop morcellating the uterus in minimally invasive and robot assisted hysterectomy and myomectomy. Change.org Inc. Available at: http://www.change.org/petitions/women-s-health-alert-deadly-cancers-of-the-uterus-spread-by-gynecologists-stop-morcellating-the-uterus-in-minimally-invasive-and-robot-assisted-hysterectomy. Accessed March 10, 2014.

      3. Morcellation. Chicago, IL: Society of Gynecologic Oncology; 2013. Available at: https://www.sgo.org/newsroom/position-statements-2/morcellation. Accessed March 1, 2014.

      4. AAGL member update: disseminated leiomyosarcoma with power morcellation (Update #2). Cypress, CA: AAGL, Advancing Minimally Invasive Gynecology Worldwide; 2014. Available at: https://www.aagl.org/aaglnews/member-update-disseminated-leiomyosarcoma-with-power-morcellation-update-2/. Accessed March 28, 2014.

        • Milad M.P.
        • Milad E.A.
        Laparoscopic morcellator-related complications.
        J Minim Invasive Gynecol. 2013 Dec 9; ([Epub ahead of print])
        • Liu Y.
        Multiple distant adenomyosis mimicking carcinomatosis on FDG PET/CT.
        Am J Obstet Gynecol. 2014; 210: 486.e1-486.e2
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        • Slovic P.
        A psychological study of the inverse relationship between perceived risk and perceived benefit: risk analysis.
        Risk Anal. 1994; 14: 1085-1096
        • Timmermans D.R.
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        • Henneman L.
        Presenting health risk information in different formats: the effect on participants' cognitive and emotional evaluation and decisions.
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        • Slovic P.
        • Finucane M.L.
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        • Kho K.A.
        • Nezhat C.H.
        Evaluating the risks of electric uterine morcellation.
        JAMA. 2014; 311: 905-906
        • American College of Obstetricians and Gynecologists
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        • Riboni F.
        • Cosma S.
        • et al.
        A safe method of vaginal longitudinal morcellation of bulky uterus with endometrial cancer in a bag at laparoscopy.
        Surg Endosc. 2014 Feb 25; ([Epub ahead of print])
        • Favero G.
        • Anton C.
        • Silva e Sivla A.
        • et al.
        Vaginal morcellation: a new strategy for large gynecological malignant tumor extraction: a pilot study.
        Gynecol Oncol. 2012; 126: 443-447
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        The debate over robotics in benign gynecology.
        Am J Obstet Gynecol. 2014; 210: 418-422
      5. FDA. 21 CFR Ch. 1 820.30, Subpart C-Design Controls. Washington, DC; Food and Drug Association; 2012. Available at: http://www.gpo.gov/fdsys/pkg/CFR-2012-title21-vol8/pdf/CFR-2012-title21-vol8-sec820-30.pdf. Accessed March 11, 2014.

      6. Pelvic Floor Disorders Registry. Frequently asked questions. Washington, DC: American Urogynecologic Society; 2014. Available at: http://pfdregistry.augs.org/p/cm/ld/fid=440. Accessed March 11, 2014.

        • Weinstein J.N.
        • Clay K.
        • Morgan T.S.
        Informed patient choice: patient-centered valuing of surgical risks and benefits.
        Health Aff (Millwood). 2007; 26: 726-730

      Linked Article

      • The debate over robotics in benign gynecology
        American Journal of Obstetrics & GynecologyVol. 210Issue 5
        • Preview
          The debate over the role of the da Vinci surgical robotic platform in benign gynecology is raging with increasing fervor and, as product liability issues arise, greater financial stakes. Although the best currently available science suggests that, in the hands of experts, robotics offers little in surgical advantage over laparoscopy, at increased expense, the observed decrease in laparotomy for hysterectomy is almost certainly, at least in part, attributable to the availability of the robot. In this author's opinion, the issue is not whether the robot has any role but rather to define the role in an institutional environment that also supports the safe use of vaginal and laparoscopic approaches in an integrated minimally invasive surgery program.
        • Full-Text
        • PDF
      • Multiple distant adenomyosis mimicking carcinomatosis on FDG PET/CT
        American Journal of Obstetrics & GynecologyVol. 210Issue 5
        • Preview
          A 45-year-old woman underwent a robotic-assisted supracervical hysterectomy with morcellation and lysis of adhesions for dysfunctional uterine bleeding and anemia. No abdominal or pelvic lesions were noted outside the uterus. The surgical specimens weighed >800 g, and pathologic evidence suggested adenomyosis and fibroid tumors. One and one-half years after surgery, the patient experienced persistent left lower quadrant pain and lost 20 lb over 3 months. Colonoscopy was unremarkable. Computed tomography showed peritoneal masses that were suspicious for carcinomatosis.
        • Full-Text
        • PDF