Obstetrics and Gynecology Devices Panel
Tuesday, May 22, 2001 – 2-5 p.m.Uterine Fibroid Embolization (UFE)
Panel Discussion Questions
FDA is currently drafting an IDE/510(k) guidance document to help in the
preparation of such submissions to the agency. Response to these discussion
questions will help with the development of this guidance document.
- Currently, the inclusion and exclusion criteria for UFE performed in
FDA-approved clinical studies of UFE are (generally) as follows:
- symptomatic uterine myoma
- premenopausal; > 30-35 years of age
- normal Pap smear, last 12 months
- regular menstrual cycles
- normal kidney function
- use or non-use of hormonal contraception must be maintained uniformly from
3 months pre-treatment through study completion
- willingness to consent and complete follow-up requirements of study
pregnancy or desire for pregnancy
gynecologic malignancy or pre-malignancy
candidate for hysteroscopic or laparoscopic myomectomy
any drug treatment for uterine fibroids within three months
active pelvic infection or history of pelvic inflammatory disease
any acute or chronic infection
undiagnosed pelvic mass outside of the uterus
history of pelvic irradiation
ASA score > IV
uterine arterio-venous fistula
allergy to IV contrast media
Please comment; are these the appropriate inclusion and exclusion criteria?
- Should hormone therapy (e.g. hormonal contraception) be an exclusion
criterion for UAE studies? If patients on hormone therapy are included,
should their data be pooled with data from patients not on any hormones, or
should they be analyzed as a subset of study subjects?
- Exclusion criteria already include gynecologic malignancy or
pre-malignancy. Should simple endometrial hyperplasia be considered a
- Other comments?
- As the primary study endpoint, FDA-approved studies currently use either a
quality of life (QoL) instrument validated for uterine fibroids or a
validated uterine bleeding scoring instrument coupled with a QoL instrument.
Secondary endpoints include adverse events, fibroid and uterine size, time
to return to normal activities, and comparisons to the non-randomized
controls. Primarily, patients are serving as their own controls, with
secondary comparisons to patients in non-randomized arms (either control
subjects undergoing myomectomy or hysterectomy). Please comment on
interpretation of these studies when completed.
- FDA currently asks for a six-month follow up (premarket), with an
additional six-month follow up (postmarket), for a total of a one-year
follow up. Is this an appropriate follow up regime?
- Preliminary results have shown that some subjects require re-treatment
- Should there be specific study requirements regarding re-treatment?
- How should the clinical study design account for this? Should these
subjects be handled as primary treatment failures?
- Can these data provide additional information on the success of UFE
- Labeling for New UFE Indication: What are the key elements that should be
covered in the professional labeling of embolyzing agents that are cleared
- How should labeling handle the issue of women who desire a future
- Should bleeding results be stratified by use and non-use of hormonal
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- Fibroid registry protocol
- Fibroid registry case report form:
- Amato, P., Roberts, A.C., "Transient ovarian failure: a complication of
uterine artery embolization," Fertil Steril 73:1241-1257, 1999.
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Muir, S., Lai, A., Sayre, J.W., DeLeon, M., "Uterine artery embolization
for the treatment of uterine leiomyomata midterm results," J Vasc
Interv Radiol 10:1159-1165, 1999.
- Hovsepian, D.M., "Uterine fibroid embolization: another paradigm shift
for interventional radiology?" J Vasc Interv Radiol 10:1145-1147,
- Hurst, B.S., Stackhouse, D.J., Matthews, M.L., Marshburn, P.B.,
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- Management of Uterine Fibroids. Summary, Evidence Report/Technology
Assessment: Number 34. AHRQ Publication No. 01-E051, January 2001. Agency for
Healthcare Research and Quality, Rockville, MD.
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