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 & SMFM Guidance on the Use of IUDs and Contraceptive Implants