Important safety information

about Dilapan-S®

INDICATION (WHEN DILAPAN-S® CAN BE USED)

DILAPAN-S® is for use wherever cervical softening and dilation are desired, such as cervical ripening prior to labor induction, cervical preparation prior to termination of pregnancy or other instrumentation of the uterine cavity.

WHEN DILAPAN-S® SHOULD NOT BE USED

DILAPAN-S® may not be used in the presence of clinically obvious genital tract infection.
DILAPAN-S® should not be left in place for more than 24 hours.

INSERTION

DILAPAN-S® can be inserted by healthcare professionals trained in obstetrics and gynecology only.
Treatment options and potential risks associated with using DILAPAN-S® for planned procedure should be discussed with your physician before the procedure.

WHAT ARE THE POTENTIAL COMPLICATIONS THAT MAY BE ASSOCIATED WITH THE USE OF DILAPAN-S®?

The following complications may be associated with use of the DILAPAN-S® device, or may occur during the indicated procedure:

  • Device entrapment and/or fragmentation or detachment of the handle
  • Device expulsion
  • Device retraction into the uterus
  • Discomfort or bleeding during and/or after insertion
  • Spontaneous rupture of membranes
  • Spontaneous onset of labor
  • Injury to the birth canal (cervical laceration)

You should be advised to report any excessive bleeding, pain, or increase in temperature.
You should o avoid bathing, douching and refrain from sexual intercourse while DILAPAN-S® is in place.

WHAT ARE THE POSSIBLE SIDE EFFECTS OF DILAPAN-S® INSERTION?

You may experience so called “vaso-vagal reaction” also known as “faintness”. This temporary status of weakness, paleness, nausea, dizziness or loss of consciousness may be caused by cervical manipulation. By remaining recumbent for 3 to 10 minutes these symptoms usually disappear.