IMPORTANT SAFETY INFORMATION FOR PATIENTS
Indication for Use
Dilapan-S® can be used to soften and dilate the cervix (called “cervical ripening”) when your OB/GYN healthcare provider recommends the need for cervical ripening in preparation for labor induction or for gynecological procedures.
Warnings & Precautions
Dilapan-S® should not be used if you have an active infection in the genital area.
Dilapan-S® rods should only be used once, left in place for no longer than 24 hours, and discarded after use or if packaging has been opened or damaged.
To avoid risk of injury to the cervix or uterus, careful placement of the rods should be done only by OB/GYN-trained healthcare providers.
After Dilapan-S® rods are in place, some minor bleeding may occur. Contact your healthcare provider if you have any excessive bleeding, pain, or temperature increase. After the Dilapan-S® rods have been inserted DO NOT take a bath, use a vaginal douche, or have intercourse. Return to your OB/GYN healthcare provider at the prescribed time for Dilapan-S® removal. Removal should be within 24 hours of insertion. DO NOT attempt to remove the rods by yourself under any circumstances.
Dilapan-S® rods falling out, spontaneous rupture of membranes (known as your “water breaking”), or onset of labor should be reported to your healthcare provider. Other risks are a cervical tear and rods sticking in place or breaking.
Treatment options and potential risks associated with using Dilapan-S® for planned labor induction should be discussed with your healthcare provider before the procedure.
Please click here to download the Instructions for Use.
If you have any questions about Dilapan-S®, be sure to discuss them with your healthcare provider. You are encouraged to report adverse events related to Dilapan-S® by calling
1 (888) 257-9676. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly.
Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.
