SMB® TCu 380A with Safeload

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: Key Features and Benefits

The SMB® TCu 380A with Safeload is an intrauterine device (IUD) designed for long-term contraception. It uses copper to prevent pregnancy by creating an inflammatory response within the uterus, making it difficult for sperm to survive. This IUD is designed for women seeking a reliable, non-hormonal contraceptive solution.

• Key Features:
  • T-shaped frame with 176+11 mg of copper wire around its vertical stem.
  • Copper collar of approximately 68.7+3 mg on each of the transverse arms.
  • 380 mm² total copper surface area for effective contraception.
  • 10 years of contraceptive effectiveness upon insertion.
  • Sterile, single-use packaging to ensure hygiene and safety during insertion.
• Benefits:
  • Provides high efficacy with minimal maintenance.
  • Non-hormonal, making it suitable for women who cannot or prefer not to use hormonal contraceptives.
  • Long-lasting protection for up to 10 years.

SMB® TCu 380A with Safeload: Indications

The SMB® TCu 380A with Safeload is indicated for intrauterine contraception in women of childbearing age. It is effective both for regular use and as emergency contraception under certain conditions. However, its use is recommended only for women who meet specific health criteria.

• Indications:
  • Contraception in women of childbearing age.
  • Can be inserted after birth or abortion.
  • Suitable for women in monogamous relationships without a history of pelvic inflammatory disease (PID).
  • Alternative for those who wish to avoid hormonal methods.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: Ingredients

The SMB® TCu 380A with Safeload is primarily composed of copper, which is the active ingredient responsible for its contraceptive effects.

• Composition:
  • Copper wire: 176 mg + 11 mg.
  • Copper collar: 68.7 mg + 3 mg.
  • HDPE monofilament thread: Attached to the device for easy removal.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: How To Use

The insertion and removal of the SMB® TCu 380A with Safeload should only be performed by trained healthcare professionals, such as gynecologists, under sterile conditions.

• Insertion:
  • The device is recommended to be inserted during the first part of the menstrual cycle, ideally after menstruation has ended.
  • A qualified healthcare professional should perform the insertion using proper sterilization techniques.
  • The device is inserted using an insertion tube, and its position should be confirmed using ultrasound if necessary.
• Removal:
  • The IUD can be removed when the user wishes to become pregnant or at the time of replacement.
  • Removal should be done using forceps, and if removal is difficult, general anesthesia may be required.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: Side Effects

As with all medical devices, the SMB® TCu 380A with Safeload can cause side effects. These side effects are generally related to the copper content and the body’s response to the device.

• Common Side Effects:
  • Spotting between periods.
  • Menstrual hemorrhages: Heavier or prolonged bleeding.
  • Pelvic pain or discomfort.
  • Abdominal pain.
  • Partial or total expulsion of the device.
• Serious Side Effects:
  • Pelvic inflammatory disease (PID), particularly within 20 days after insertion.
  • Uterine perforation: Rare but may occur during insertion.
  • Ectopic pregnancy if pregnancy occurs with the IUD in place.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: Clinical Studies

The clinical efficacy and safety of the SMB® TCu 380A with Safeload have been demonstrated through studies comparing its performance to other contraceptive methods.

• Efficacy:
  • The device is highly effective in preventing pregnancy, with a typical use failure rate of less than 1% per year.
• Safety:
  • Clinical studies have shown that the incidence of serious complications such as PID and uterine perforation is low, though risks increase if the device is inserted shortly after delivery or abortion.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: Manufacturer Information

The SMB® TCu 380A with Safeload is manufactured by SMB and is classified as a Class III medical device under the European Union’s medical device regulations.

• Manufacturing Details:
  • The device is sterilized using Gamma Radiation or Ethylene Oxide.
  • It has been CE-certified since 2004, ensuring compliance with safety standards.
  • Shelf life of 7 years; to be stored at 15°C to 30°C in a dry place, away from sunlight and moisture.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: Contraindications

Certain conditions and circumstances prohibit the use of the SMB® TCu 380A with Safeload.

• Absolute Contraindications:
  • Pregnancy or a history of pelvic inflammatory disease (PID).
  • Genital tract malignancy or unexplained vaginal bleeding.
  • Known allergy to copper.
• Relative Contraindications:
  • Severe dysmenorrhea or painful menstruation.
  • Blood coagulation disorders.

SMB® TCu Intrauterine Device (IUD) 380A with Safeload: FAQ

• Q: Can the SMB® TCu 380A with Safeload be used as emergency contraception?
  • A: Yes, it can be used within 5 days after unprotected intercourse but may carry a higher risk of PID in this case.
• Q: How long does the SMB® TCu 380A with Safeload last?
  • A: It provides contraceptive protection for up to 10 years.
• Q: Can the SMB® TCu 380A with Safeload be used immediately after childbirth?
  • A: It is not recommended to insert the device before 6 weeks postpartum to reduce risks of complications.