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46 experts pen open letter to the FDA on uterine power morcellation

As gynecologists are well aware, in November 2014, the FDA issued a safety communication, warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” Now, a group of 46 experts in gynecologic surgery, including Dr. Eva Chalas, question the FDA’s decision and provide their own clinical recommendations for FDA consideration.

In this interview with Dr. Chalas, she discusses:

  • why this letter needed to be written now
  • why, as an oncologist, she felt she needed to sign the letter
  • concerns with the data the FDA used to make their recommendation 1 year ago
  • the effects of the FDA’s warning over time
  • more.

 Click here to read the open letter to the FDA.

References

Reference

 

  1. US 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. Accessed November 19, 2015.
Author and Disclosure Information

Dr. Chalas is Chief of Gynecologic Oncology and Director of Clinical Cancer Services at Winthrop-University Hospital in Mineola, New York.

Dr. Chalas reports that she receives grant or research support from NCI and is a speaker for Astra-Zeneca.

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OBG Management - 27(12)
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Eva Chalas MD,uterine power morcellation,open letter, hysterectomy, myomectomy, fibroids,46 minimally invasive surgeons,occult leiomyosarcoma,gynecologic oncology,laparotomy,open hysterectomy,laparoscopic hysterectomy
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Author and Disclosure Information

Dr. Chalas is Chief of Gynecologic Oncology and Director of Clinical Cancer Services at Winthrop-University Hospital in Mineola, New York.

Dr. Chalas reports that she receives grant or research support from NCI and is a speaker for Astra-Zeneca.

Author and Disclosure Information

Dr. Chalas is Chief of Gynecologic Oncology and Director of Clinical Cancer Services at Winthrop-University Hospital in Mineola, New York.

Dr. Chalas reports that she receives grant or research support from NCI and is a speaker for Astra-Zeneca.

Related Articles

As gynecologists are well aware, in November 2014, the FDA issued a safety communication, warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” Now, a group of 46 experts in gynecologic surgery, including Dr. Eva Chalas, question the FDA’s decision and provide their own clinical recommendations for FDA consideration.

In this interview with Dr. Chalas, she discusses:

  • why this letter needed to be written now
  • why, as an oncologist, she felt she needed to sign the letter
  • concerns with the data the FDA used to make their recommendation 1 year ago
  • the effects of the FDA’s warning over time
  • more.

 Click here to read the open letter to the FDA.

As gynecologists are well aware, in November 2014, the FDA issued a safety communication, warning “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” Now, a group of 46 experts in gynecologic surgery, including Dr. Eva Chalas, question the FDA’s decision and provide their own clinical recommendations for FDA consideration.

In this interview with Dr. Chalas, she discusses:

  • why this letter needed to be written now
  • why, as an oncologist, she felt she needed to sign the letter
  • concerns with the data the FDA used to make their recommendation 1 year ago
  • the effects of the FDA’s warning over time
  • more.

 Click here to read the open letter to the FDA.

References

Reference

 

  1. US 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. Accessed November 19, 2015.
References

Reference

 

  1. US 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. Accessed November 19, 2015.
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OBG Management - 27(12)
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OBG Management - 27(12)
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Display Headline
46 experts pen open letter to the FDA on uterine power morcellation
Display Headline
46 experts pen open letter to the FDA on uterine power morcellation
Legacy Keywords
Eva Chalas MD,uterine power morcellation,open letter, hysterectomy, myomectomy, fibroids,46 minimally invasive surgeons,occult leiomyosarcoma,gynecologic oncology,laparotomy,open hysterectomy,laparoscopic hysterectomy
Legacy Keywords
Eva Chalas MD,uterine power morcellation,open letter, hysterectomy, myomectomy, fibroids,46 minimally invasive surgeons,occult leiomyosarcoma,gynecologic oncology,laparotomy,open hysterectomy,laparoscopic hysterectomy
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