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

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 Releases Practice Bulletin on the Use of IUDs and Contraceptive Implants