SMB® TCu 380A with Safeload

SMB® TCu 380A with Safeload is a T-shaped intrauterine device (IUD) used for long-term contraception, effective for up to 10 years. It features a polyethylene frame wound with copper wire (176 ±11 mg) and two copper sleeves (68.7 ±3 mg each) on the horizontal arms, providing a total copper surface area of 380 mm² ±23 mm².

The device works by inducing a local inflammatory reaction in the endometrium that is toxic to sperm and ova, thereby preventing fertilization. The Safeload system ensures sterile, precise insertion, and the IUD is radiopaque, with a monofilament HDPE thread for easy removal. It is a hormone-free, non-barrier, reversible method suited for women who prefer non-hormonal birth control or cannot tolerate hormonal methods.

• Provides contraceptive protection for up to 10 years
• Suitable for women of childbearing age, including postpartum and post-abortion insertion
• Requires professional insertion under aseptic conditions

The device must be inserted by a qualified healthcare professional using sterile, no-touch technique and standard gynecological instruments. Insertion is recommended during the first 7 days of the menstrual cycle for optimal ease and safety.

Key Features:

• Long-term non-hormonal contraception
• Safeload system allows controlled and hygienic insertion

Protocol Details:

• Insertion timing: Within 7 days of menstruation onset or 6–12 weeks postpartum
• Placement: Inserted into the uterine cavity using the provided insertion system
• Technique: Insert under aseptic conditions using the supplied solid rod and insertion tube
• Removal: Gently traction the monofilament string with forceps
• Reinsertion interval: Immediately after removal if continued contraception is desired

SMB® TCu 380A is indicated for intrauterine contraception in women of reproductive age and may be used as emergency contraception when inserted within 5 days of unprotected intercourse.

Indications:

• Long-term contraception (up to 10 years)
• Postpartum or post-abortion contraception
• Emergency contraception (higher PID risk)

Contraindications:

• Pregnancy or suspicion of pregnancy
• Pelvic inflammatory disease (current or past)
• Genital tract malignancy
• Untreated cervicitis or vaginitis
• STD or high STD risk (e.g., multiple partners)
• Wilson’s disease or copper allergy
• Uterine abnormalities or fibroids
• Unresolved abnormal Pap smear
• Severe anemia or bleeding disorders

Side Effects:

• Spotting between periods
• Menorrhagia (heavy/prolonged bleeding)
• Abdominal cramps
• Expulsion or perforation
• Pelvic infections

The device is made from biocompatible plastic and copper, optimized for contraceptive efficacy and long-term placement.

• Frame: T-shaped polyethylene (HDPE)
• Vertical stem: Wrapped with 176 ±11 mg of copper wire
• Arms: Fitted with two copper collars (68.7 ±3 mg each)
• Thread: Monofilament HDPE, radiopaque
• Total copper surface area: 380 mm² ±23 mm²

Each sterile unit is a single-use kit containing all components required for insertion under clinical supervision.

• 1 sterile SMB® TCu 380A IUD
• Insertion tube with flange
• Solid rod for loading
• Monofilament removal thread
• Sterile packaging for single use
• Shelf life: 7 years

While generally well tolerated, the SMB® TCu 380A can cause mild to moderate side effects, especially shortly after insertion.

Common Side Effects:

• Cramping or pelvic pain
• Menstrual changes (heavy bleeding, longer periods)
• Spotting between periods

Less Common/Rare:

• Expulsion (especially in first months)
• Perforation (rare, especially in lactating women or early postpartum)
• Pelvic inflammatory disease (PID)
• Ectopic pregnancy if conception occurs
• Uterine infection or allergic reaction to copper

Proper storage ensures the integrity and sterility of the device until use.

• Storage temperature: 15°C to 30°C (59°F to 86°F)
• Keep in dry place, away from direct sunlight and heat
• Avoid mechanical damage
• Shelf life: 7 years from manufacturing date
• Use only if packaging is intact and expiration date not exceeded