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sterilization
Telectronics Pacing Systems
Summary: Sterilization is a medical device used for permanent contraception. It is primarily used in female sterilization procedures. Key evidence highlights its widespread use and the importance of informed consent.
FDA Clearance Information
Pathway
510K
Number
K943657 ↗
Decision Date
June 24, 1996
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The sterilization device by Telectronics Pacing Systems was cleared through the FDA 510k pathway on June 24, 1996. It is classified as a Class 3 device.
What It Is
The sterilization device is designed for permanent contraception, primarily through tubal ligation or occlusion. It is intended for use in female sterilization procedures to prevent future pregnancies.
Clinical Applications
This device is commonly used in clinical scenarios such as postpartum tubal ligation, laparoscopic tubal disruption, and hysteroscopic tubal occlusion. It is a critical tool in family planning and reproductive health.
Evidence Summary
The available literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses. The studies span from 2008 to 2022, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that sterilization is a highly effective method of contraception with a low failure rate. It is widely used and accepted globally, with high satisfaction rates among patients. The procedure is noted for its simplicity and accessibility.
Safety Profile
Reported complications include surgical risks such as infection, bleeding, and anesthesia-related issues. Long-term complications are rare but may include regret and the desire for reversal, which can be complex and costly.
Evidence Limitations
The evidence is limited by the lack of long-term follow-up studies and the potential for selection bias in retrospective analyses. Further research is needed to explore the psychological impacts and long-term satisfaction rates.
Frequently Asked Questions
What are the clinical indications for sterilization?
Sterilization is indicated for permanent contraception in women who have completed their families or for whom pregnancy poses a health risk.
What outcomes have been reported in clinical studies?
Studies report high efficacy and satisfaction rates, with sterilization being a widely accepted method of contraception.
What complications have been reported?
Safety data indicate risks such as infection, bleeding, and anesthesia-related issues, with rare cases of regret and desire for reversal.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.