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Grand Rounds

Hysteroscopic vs Laparoscopic Sterilization for Contraception

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BACKGROUND AND PURPOSE: 

  • Approximately 50% of pregnancies in the US are unintended 
  • One-third of women (35 to 44 years of age) use female sterilization for contraception 
  • The FDA had received multiple reports of adverse gynecologic and medical outcomes with the use of the Essure hysteroscopic sterilization system  
    • 2016: FDA “black box” warning  
    • 2017: Non-US sales stopped for “commercial reasons”  
  • Bouillon et al. (JAMA, 2018) compared the risks associated with hysteroscopic and laparoscopic sterilization

METHODS: 

  • French nationwide cohort study based on a national hospital discharge database  
  • Participants: Women aged 30 to 54 years receiving first hysteroscopic or laparoscopic sterilization (2010-2014) 
  • All women received either 
    • Hysteroscopic sterilization 
    • Laparoscopic sterilization 
  • Primary outcomes  
    • Procedural complications (surgical and medical)  
    • Medical outcomes (all types of allergy, autoimmune, etc.) 
  • Gynecological events included  
    • Complications related to the placement of a prosthesis or implant 
    • Uterine disorder (e.g., hysterectomy, genital hemorrhage, endometrectomy or curettage, or myomectomy) 
    • Second sterilization procedure  
    • Pregnancy 
    • Two composite gynecological outcomes: (1) sterilization failure and (2) reoperation

RESULTS: 

  • 105,357 women were included in the study 
    • Mean age, 41.3 years (SD, 3.7 years) 
    • 71,303 (67.7%) underwent hysteroscopic sterilization 
    • 34,054 (32.3%) underwent laparoscopic sterilization 
  • Risk of surgical complications during hospitalization for sterilization were lower for hysteroscopic sterilization (0.13%) vs laparoscopic sterilization (0.78%)  
    • Adjusted risk difference (RD) -0.64; 95% CI, -0.67 to -0.60  
  • Risk of medical complications were also lower for hysteroscopic sterilization (0.06%) vs laparoscopic sterilization (0.11%)   
    • Adjusted RD -0.05; 95% CI, -0.08 to -0.01 
  • During the first year following sterilization  
    • Risk of sterilization failure was higher for hysteroscopic group (4.83%) vs the laparoscopic group (0.69%)  
      • Adjusted hazard ratio (HR) 7.11; 95% CI, 5.92 to 8.54  
    • Risk for gynecological reoperation was higher hysteroscopic sterilization (5.65%) vs laparoscopic sterilization (1.76%)  
      • Adjusted HR 3.26; 95% CI, 2.90 to 3.67 
    • Association persisted into the third year  
  • During the first year following sterilization, risk of pregnancy was lower in the hysteroscopic sterilization group but was not statistically significant by the third year  
  • Risks of medical outcomes were not significantly increased with hysteroscopic sterilization compared with laparoscopic sterilization

CONCLUSION: 

  • Hysteroscopic sterilization was associated with higher risk of gynecological complications over 1 year and over 3 years, compared to laparoscopic sterilization 
  • There was no increased risk for medical adverse outcomes in the hysteroscopic group 
  • These findings do not support increased medical risks associated with hysteroscopic sterilizations 

Learn More – Primary Sources:  

Association of Hysteroscopic vs Laparoscopic Sterilization With Procedural, Gynecological, and Medical Outcomes 

JAMA Editorial: Evaluating the Long-term Safety of Hysteroscopic Sterilization

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Related ObG Topics:

Which are the Most Safe and Effective Female Sterilization Surgeries?
FDA Issues an Order to Restrict the Sale and Distribution of Essure
ACOG & SMFM Guidance on the Use of IUDs and Contraceptive Implants

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