17****PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information). Before inserting Paragard, counsel patients on the following:

Sexually Transmitted Infections: Advise patients that Paragard does not protect against HIV infection and other sexually transmitted diseases.

Ectopic Pregnancy: Advise patients to report pregnancies and be evaluated immediately, as a pregnancy with Paragard in place is more likely to be an ectopic pregnancy, and the risks of ectopic pregnancy include the loss of fertility [see Warnings and Precautions (5.1)].

Intrauterine Pregnancy: Advise patients to report pregnancies and be evaluated immediately, as an intrauterine pregnancy with Paragard in place, may result in septic abortion, with septicemia, septic shock, and possible death. Septic abortion typically requires hospitalization and treatment with intravenous antibiotics. Septic abortion may result in spontaneous abortion or a medical indication for pregnancy termination. A hysterectomy may be required if severe infection of the uterus occurs, which will result in permanent infertility. If Paragard remains in the uterus during a pregnancy, there is an increased risk of miscarriage, sepsis, premature labor and premature delivery. Advise patients that a pregnancy must be followed closely and advise patients to report immediately any symptom, such as flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge or leaking of fluid, or any other symptom that suggests complications of the pregnancy [see Warnings and Precautions (5.2)].

Sepsis: Advise patients that sepsis may occur after insertion of Paragard and to seek immediate treatment for fever and pelvic pain that occurs soon after insertion, as untreated sepsis can result in death [see Warnings and Precautions (5.3)].

Pelvic Inflammatory Disease: Advise patients that pelvic inflammatory disease (PID) may occur after insertion of Paragard and that PID can cause tubal damage leading to ectopic pregnancy or infertility, or can necessitate hysterectomy, or cause death. Advise patients to recognize and report promptly any symptoms of PID including development of menstrual disorders (prolonged or heavy bleeding), unusual vaginal discharge, abdominal or pelvic pain or tenderness, dyspareunia, chills, and fever [see Warnings and Precautions (5.4)].

Embedment, Perforation, and Expulsion: Advise patients regarding the risks of embedment, perforation, and expulsion and inform patients that in some cases, removal of Paragard may be difficult and surgical removal may be necessary. Inform patients that perforation can cause infection, scarring, damage to other organs, pain, or infertility. Inform patients that excessive pain or vaginal bleeding during IUS placement, worsening pain or bleeding after placement, or the inability to feel the IUS strings may occur with IUS perforation and expulsion. There is no protection from pregnancy if Paragard is displaced or expelled. [see Warnings and Precautions (5.5, 5.6, 5.7).]

Bleeding Pattern Alterations: Advise patients that heavier or longer periods and spotting between periods may occur. Instruct patients to report continued or severe symptoms to their healthcare provider [see Warnings and Precautions (5.9)].

Checking for Paragard: Advise patients to check that Paragard is still in the uterus by reaching up to the top of the vagina with clean fingers to feel the two threads. Inform patients not to pull on the threads, which could displace Paragard. Advise patients to promptly report if there are changes in the length of the two threads, if they cannot locate the threads, or they can feel any other part of Paragard besides the threads.

Magnetic Resonance Imaging (MRI) Safety Information: Inform patients that Paragard can be safely scanned with MRI only under specific conditions. Instruct patients who will have an MRI to tell their healthcare provider that they have Paragard [see Warnings and Precautions (5.10)].

Medical Diathermy: Instruct patients to tell their healthcare provider that they have Paragard prior to undergoing medical diathermy [see Warnings and Precautions (5.11)].

Other Important Information:

1. Advise patients to contact their healthcare provider if any of the following occur:
   ●Pelvic pain or pain during sex
   ● Unusual vaginal discharge or genital sores
   ● Possible exposure to STIs
   ● HIV positive seroconversion in herself or her partner
   ● Severe or prolonged vaginal bleeding
   ● Missed period

2. Advise patients that they may use tampons or pads while wearing Paragard.

Manufactured by:

CooperSurgical, Inc.
Trumbull, CT 06611