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.

  1. Currently, the inclusion and exclusion criteria for UFE performed in FDA-approved clinical studies of UFE are (generally) as follows:

Inclusion Criteria

  1. symptomatic uterine myoma
  2. premenopausal; > 30-35 years of age
  3. normal Pap smear, last 12 months
  4. regular menstrual cycles
  5. normal kidney function
  6. use or non-use of hormonal contraception must be maintained uniformly from 3 months pre-treatment through study completion
  7. willingness to consent and complete follow-up requirements of study

Exclusion Criteria

  1. pregnancy or desire for pregnancy
  2. gynecologic malignancy or pre-malignancy
  3. adenomyosis
  4. candidate for hysteroscopic or laparoscopic myomectomy
  5. any drug treatment for uterine fibroids within three months pre-treatment
  6. active pelvic infection or history of pelvic inflammatory disease
  7. any acute or chronic infection
  8. undiagnosed pelvic mass outside of the uterus
  9. coagulopathy
  10. history of pelvic irradiation
  11. ASA score > IV
  12. uterine arterio-venous fistula
  13. allergy to IV contrast media

 

Please comment; are these the appropriate inclusion and exclusion criteria?

 

  1. 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.
  2. 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?
  3. Preliminary results have shown that some subjects require re-treatment with UFE.
  1. Labeling for New UFE Indication: What are the key elements that should be covered in the professional labeling of embolyzing agents that are cleared for UFE?

Background Materials

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