T-SAFE® CU 380A QL IUD

Description

Name:T-SAFE® CU 380A QL IUD
Manufacturer: Mona Lisa N.V.
Active Substance(s): COPPER
Strength: 380mm2
Pack Size: 38OA 1IUD
Accessories: 1 x 380mg T-Shaped IUD

The T-SAFE® CU 380A QL IUD is a long-acting, non-hormonal intrauterine contraceptive device (IUD) that offers up to 10 years of protection. It is made of a T-shaped polyethylene frame enhanced with copper wire and copper sleeves on the side arms. The copper creates a sterile inflammatory response in the uterus, inhibiting sperm motility and fertilization. Designed for both nulliparous and parous women, it is a suitable option for those who prefer or require hormone-free contraception.

Key Features:

• 380 mm² total copper surface for high contraceptive efficacy over 10 years.
• Flexible T-shaped frame that fits well in uterine cavities sized 6.5–9 cm in depth.
• Radiopaque construction using polyethylene and barium sulfate for X-ray visibility.

This IUD is packaged in a sterile heat-sealed Tyvek + PET/PE pouch, ensuring product integrity. It is single-use only and sterilized with ethylene oxide. The device must not be resterilized or used if the package is opened or damaged.

Packaging Includes:

• 1 sterile T-SAFE® CU 380A QL IUD
• Hysterometer
• Inserter tube with insertion body
• Insertion rod (plunger)

Ingredients:

• Copper (wire and sleeves)
• Polyethylene (frame)
• Barium Sulphate (radiopacity)
• Polyamide 6 (threads)

The T-SAFE® CU 380A QL IUD is indicated for:

• Long-term intrauterine contraception (up to 10 years)
• Emergency contraception (within 5 days of unprotected intercourse)
• Use in breastfeeding women, and those with contraindications to hormonal methods

Contraindications Include:

• Pregnancy or suspicion thereof
• History of ectopic pregnancy, pelvic inflammatory disease, or cervical/endometrial cancer
• Heavy menstrual bleeding or endometriosis
• Wilson’s disease or known copper allergy
• Active STIs or abnormal uterine anatomy

Possible Side Effects:

• Heavier and longer menstruation, occasional spotting
• Pelvic infections (especially within the first month)
• Lower abdominal pain or dysmenorrhea
• Perforation risk: 1.1 per 1000 insertions for copper IUDs; higher with breastfeeding or early postpartum insertion
• Allergic reactions and vasovagal responses during insertion in sensitive individuals

Trained medical professionals must insert the IUD. The ideal time for insertion is during menstruation, but it can also be inserted postpartum (after 6–12 weeks) or post-abortion (within 15 minutes or after 6 weeks). For emergency contraception, it can be inserted within 5 days of unprotected sex.

Insertion Procedure:

• Confirm non-pregnant status and assess uterine depth (6.5–9 cm)
• Use sterile technique with gloves and instruments
• Load IUD into inserter, ensuringthe  arms are positioned correctly
• Insert until the flange touches the cervix
• Release arms by pulling the insertion body, and remove instruments carefully
• Trim threads to leave 2–3 cm visible outside cervix
  

Removal is typically done during menstruation and involves gentle traction on the threads using forceps or a tenaculum.

Storage Guidelines:

• Temperature: Store between 0°C and 35°C
• Conditions: Dry place, away from direct sunlight and moisture
• Do not use after expiry date

Warning! The product is intended solely for professional use in a medical environment and under professional supervision. The product is supplied to medical professionals who specialize in aesthetic medicine (plastic surgery, facial treatments) and work under individual medical licenses as aestheticians or in dedicated clinics. Unprofessional use by individuals without a medical background may lead to severe adverse effects and health harm.