N-of-1 policymaking - tragedy, trade-offs, and the demise of morcellation

New England Journal of Medicine

Volumn 374, Issue 10, 2016, Pages 986-990

  Rosenbaum, Lisa ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ABDOMINAL HYSTERECTOMY; ABDOMINAL PAIN; ARTICLE; AUTOIMMUNE DISEASE; CANCER INCIDENCE; CANCER RISK; CANCER STAGING; COMPUTER ASSISTED TOMOGRAPHY; COST EFFECTIVENESS ANALYSIS; DEPRESSION; EMERGENCY WARD; FATIGUE; HEALTH CARE AVAILABILITY; HEALTH CARE POLICY; HIGH RISK PATIENT; HUMAN; HYSTERECTOMY; INCISION; INCISIONAL HERNIA; INTRAOPERATIVE PERIOD; LAPAROSCOPIC SURGERY; LEIOMYOSARCOMA; MINIMALLY INVASIVE SURGERY; MORCELLATION; MYOMECTOMY; OUTCOME ASSESSMENT; PATIENT SAFETY; POSTMENOPAUSE; PREOPERATIVE PERIOD; PREVALENCE; PRIORITY JOURNAL; QUALITY ADJUSTED LIFE YEAR; RISK ASSESSMENT; RISK FACTOR; SURGICAL APPROACH; SURGICAL INFECTION; SURVIVAL RATE; UTERUS MYOMA; VENOUS THROMBOEMBOLISM; ADVERSE EFFECTS; DRUG APPROVAL; ETHICS; FEMALE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; LEGISLATION AND JURISPRUDENCE; LEIOMYOMA; PROCEDURES; TUMOR SEEDING; UNITED STATES; UTERINE NEOPLASMS;

DRUG APPROVAL; FEMALE; GOVERNMENT REGULATION; HUMANS; HYSTERECTOMY; LEIOMYOMA; LEIOMYOSARCOMA; MORCELLATION; NEOPLASM SEEDING; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; UTERINE MYOMECTOMY; UTERINE NEOPLASMS;

EID: 84960467220     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMms1516161     Document Type: Article

References (18)

1. Stewart EA. Uterine fibroids. N Engl J Med 2015; 372: 1646-55.
2. American Cancer Society. Survival rates for uterine sarcoma, by stage. 2015 (http://www .cancer .org/cancer/uterinesarcoma/detailedguide/uterine-sarcoma-survival-rates).
3. Hall T, Lee SI, Boruta DM, Goodman A. Medical device safety and surgical dissemination of unrecognized uterine malignancy: morcellation in minimally invasive gynecologic surgery. Oncologist 2015; 20: 1274-82.
4. Levitz J, Kamp J. Deadly medicine: A common surgery for women and the cancer it leaves behind. New York; Wall Street Journal e-book, 2015.
5. Food and Drug Administration. Quantitative assessment of the prevalence of unsuspected uterine sarcoma in women undergoing treatment of uterine fibroids. Summary and key findings. April 17, 2014 (http://www .fda .gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM393589 .pdf).
6. Food and Drug Administration. Updated laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. November 24, 2014 (http://www .fda .gov/MedicalDevices/Safety/AlertsandNotices/ucm424443 .htm).
7. Parker WH, Kaunitz AM, Pritts EA, et al. U.S. Food and Drug Administrations guidance regarding morcellation of leiomyomas: well-intentioned, but is it harmful for women? Obstet Gynecol 2016; 127: 18-22.
8. 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: 591.e1-8.
9. Pritts EA, Vanness DJ, Berek JS, et al. The prevalence of occult leiomyosarcoma at surgery for presumed uterine fibroids: A meta-Analysis. Gynecol Surg 2015; 12: 165-77.
10. Miller HI. The agency that cant get a head. National Review May 2, 2006 (http://www .nationalreview .com/article/217513/agency-cant-get-head-henry-i-miller).
11. Friedman RA. Antidepressants black-box warning-10 years later. N Engl J Med 2014; 371: 1666-8.
12. Lu CY, Zhang F, Lakoma MD, et al. Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study. BMJ 2014; 348: g3596.
13. Gigerenzer G. Out of the frying pan into the fire: behavioral reactions to terrorist attacks. Risk Anal 2006; 26: 347-51.
14. Angell M. Shattuck Lecture-evaluating the health risks of breast implants: The interplay of medical science, the law, and public opinion. N Engl J Med 1996; 334: 1513-8.
15. Kuran T, Sunstein C. Availability cascades and risk regulation. Stanford Law Rev 1999; 51: 683-768.
16. Vanderford M, Smith D. The silicone breast implant story: communication and uncertainty. Digital version. New York and London: Routledge Taylor and Francis Group, 2009.
17. Noorchashm H, Reed A. The death of medical ethics in America: "Ye cannot serve God and mammon." Philadelphia Inquirer. April 13, 2015.
18. Motluk A. Worth the risk? Maisonneuve. November 10, 2015 (http://maisonneuve .org/article/2015/11/10/worth-risk/).