Hysteroscopy pp 315-322 | Cite as

Hysteroscopy in Contraception: Side Effects Review—Is There Really a Problem?

Chapter

Abstract

Outpatient hysteroscopic sterilisation without anaesthetic, using the Essure® system, is quick, successful, safe, and associated with a high rate of patient satisfaction. The technique provides a convenient, cost-effective, and welcome alternative to couples regarding their choice of permanent fertility control. However, that permanent birth control presents adverse effects of the procedure: pain, discomfort, vasovagal syncope, nausea, fainting; benign adverse effects: pain, contractions, vaginal bleeding, discharge, pelvic inflammatory disease, menstrual period turned irregular, allergic reactions; and serious side effects: expulsion, perforation, failure, risk of regret. Erin Brockovich warned about new adverse events. According to her they could be caused by the Essure device: skin rash, chronic infections (vaginal, respiratory), fatigue, chronic sleeping, shakiness, memory loss, autoimmune disease, loss of voice, dysesthesia, blood pressure drop, weight changes, hair loss, mood changes such as depression, and various kinds of pain including headache, muscle pain, pain in legs, and so on.

Mechanically, it’s hard to charge Essure of all those side events. But nickel could affect the hypothalamic–pituitary–adrenal axis and cause a lot of symptoms. It could be interesting to study Essure’s heavy materials dose delivered and its effects on women’s bodies.

Keywords

Essure® Sterilisation Adverse effects Side events Risks Allergy Nickel Heavy materials 

Notes

Conflict of Interest

P. Baissas declares no potential conflicts of interest with respect to the research, authorship, and/or publication of this chapter.

P. Panel is coordinating a medical study sponsored by Bayer Company.

References

  1. 1.
    Grosdemouge I, Engrand J-B, Dhainault C, Marchand F, Martigny H, Thevenot J, et al. Essure implants for tubal sterilisation in France. Gynecol Obstet Fertil. 2009;37(5):389–95. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19410494. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  2. 2.
    Panel P, Jost S, Grosdemouge I, Friederich L, Niro J, Le Tohic A. Contraception permanente par pose hystéroscopique d’implants tubaires. Gynécologie Obs Fertil. 2012;40(7–8):434–44. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22658908. [Internet; Cited 01 Feb 2017].CrossRefGoogle Scholar
  3. 3.
    Kerin J, Carignan C, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure™ pbc clinical study. Aust N Z J Obstet Gynaecol. 2001;41(4):364–70. Available from: http://doi.wiley.com/10.1111/j.1479-828X.2001.tb01311.x. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  4. 4.
    Menez C, Lopes P. A new hysteroscopic method for sterilization: 45 patients. J Gynecol Obstet Biol Reprod (Paris). 2004;33(3):221–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15170436. [Internet; Cited 01 Feb 2017].CrossRefGoogle Scholar
  5. 5.
    Al-Safi ZA, Shavell VI, Hobson DTG, Berman JM, Diamond MP, Chapman L, et al. Analysis of adverse events with Essure hysteroscopic sterilization reported to the Manufacturer and User Facility Device Experience database. J Minim Invasive Gynecol. 2005;20(6):825–9. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24183273. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  6. 6.
    Brito LGO, Cohen SL, Goggins ER, Wang KC, Einarsson JI. Essure surgical removal and subsequent symptom resolution: case series and follow-up survey. J Minim Invasive Gynecol. 2015;22(5):910–3.CrossRefPubMedGoogle Scholar
  7. 7.
    Chern B, Siow A. Initial Asian experience in hysteroscopic sterilisation using the Essure permanent birth control device. BJOG An Int. J Obstet Gynaecol. 2005;112(9):1322–7. Available from: http://doi.wiley.com/10.1111/j.1471-0528.2005.00436.x. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  8. 8.
    Povedano B, Arjona J, Velasco E, Monserrat J, Lorente J, Castelo-Branco C. Complications of hysteroscopic Essure® sterilisation: report on 4306 procedures performed in a single centre. BJOG. 2012;119(7):795–9. Available from: http://doi.wiley.com/10.1111/j.1471-0528.2012.03292.x. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  9. 9.
    Friederich L, Chis C, Panel P. Comment je fais... une hystéroscopie avec pose d’implants Essure® par vaginoscopie. Gynécologie Obs Fertil. 2008;36(12):1239–40. Available from: http://linkinghub.elsevier.com/retrieve/pii/S1297958908004542. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  10. 10.
    Grosdemouge I, Engrand J-B, Dhainault C, Marchand F, Martigny H, Thevenot J, et al. La pratique française de la pose des implants de stérilisation tubaire Essure®. Gynécologie Obs Fertil. 2009;37(5):389–95. Available from: http://www.ncbi.nlm.nih.gov/pubmed/19410494. [Internet; Cited 01 Feb 2017].CrossRefGoogle Scholar
  11. 11.
    Sinha D, Kalathy V, Gupta J, Clark T. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. BJOG. 2007;114(6):676–83. Available from: http://doi.wiley.com/10.1111/j.1471-0528.2007.01351.x. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  12. 12.
    Panel P, Grosdemouge I, Duffy S, Marsh F, Rogerson L, Hudson H, et al. Predictive factors of Essure® implant placement failure: prospective, multicenter study of 495 patients. Fertil Steril. 2010;93(1):29–34. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0015028208040582. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  13. 13.
    Langenveld J, Veersema S, Bongers MY, Koks CA. Tubal perforation by Essure: three different clinical presentations. Fertil Steril. 2008;90(5):2011.e5–2011.e10. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18692813. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  14. 14.
    Vleugels MPH, Heckel S, Veersema S, Engrand JB, Villefranque V, Fernandez H, et al. Hysteroscopic sterilization with Essure® device in situ: a challenge? Gynecol Surg. 2011;8(1):51–5. Available from: http://link.springer.com/10.1007/s10397-010-0615-y. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  15. 15.
    Hopkins MR, Creedon DJ, El-Nashar SA, Brown DL, Good AE, Famuyide AO. Radiofrequency global endometrial ablation followed by hysteroscopic sterilization. J Minim Invasive Gynecol. 2007;14(4):494–501.CrossRefPubMedGoogle Scholar
  16. 16.
    Valle RF, Valdez J, Wright TC, Kenney M. Concomitant Essure® tubal sterilization and Thermachoice® endometrial ablation: feasibility and safety. Fertil Steril. 2006;86(1):152–8.CrossRefPubMedGoogle Scholar
  17. 17.
    Donnadieu AC, Deffieux X, Gervaise A, Faivre E, Frydman R, Fernandez H. Essure® sterilization associated with endometrial ablation. Int J Gynecol Obstet. 2007;97(2):139–42.CrossRefGoogle Scholar
  18. 18.
    Mircea CN, Goojha C, Thiel JA. Concomitant NovaSure endometrial ablation and essure tubal sterilization: a review of 100 cases. J Obstet Gynaecol Can. 2011;33(4):361–6. Available from: http://linkinghub.elsevier.com/retrieve/pii/S170121631634854X. [Internet; Cited 25 Jan 2017].CrossRefPubMedGoogle Scholar
  19. 19.
    Schäfer T, Böhler E, Ruhdorfer S, Weigl L, Wessner D, Filipiak B, et al. Epidemiology of contact allergy in adults. Allergy. 2001;56(12):1192–6. Available from: http://doi.wiley.com/10.1034/j.1398-9995.2001.00086.x. [Internet; Cited 18 Jan 2017].CrossRefPubMedGoogle Scholar
  20. 20.
    Basinski CM, Juran RS, Fein A. Essure® Sterilization: experience and outcomes with 1024 patients in a solo practice over 8 years. J Gynecol Surg. 2016;32(3):173–8. Available from: http://online.liebertpub.com/doi/10.1089/gyn.2015.0103. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  21. 21.
    Zurawin RK, Zurawin JL. Adverse events due to suspected nickel hypersensitivity in patients with Essure micro-inserts. J Minim Invasive Gynecol. 2011;18(4):475–82.CrossRefPubMedGoogle Scholar
  22. 22.
    Staerkjaer L, Menne T. Nickel allergy and orthodontic treatment. Eur J Orthod. 1990;12(3):284–9. Available from: https://academic.oup.com/ejo/article-lookup/doi/10.1093/ejo/12.3.284. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  23. 23.
    Jia Z, Tu J, Wang K, Jiang G, Wang W. Allergic reaction following implantation of a nitinol alloy inferior vena cava filter. J Vasc Interv Radiol. 2015;26(9):1375–7.CrossRefPubMedGoogle Scholar
  24. 24.
    Siemons S, Vleugels M, van Eijndhoven H. Evaluation of nickel allergic reactions to the Essure micro insert: theoretical risk or daily practice? J Minim Invasive Gynecol. 2017;24(1):140–4. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27621196. [Internet; Cited 25 Jan 2017].CrossRefPubMedGoogle Scholar
  25. 25.
    Bibas N, Lassere J, Paul C, Aquilina C, Giordano-Labadie F. Nickel-induced systemic contact dermatitis and intratubal implants. Dermatitis. 2013;24(1):35–6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/23340398. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  26. 26.
    Hillen U, Haude M, Erbel R, Goos M. Evaluation of metal allergies in patients with coronary stents. Contact Dermatitis. 2002;47(6):353–6. Available from: http://doi.wiley.com/10.1034/j.1600-0536.2002.470607.x. [Internet; Cited 18 Jan 2017].CrossRefPubMedGoogle Scholar
  27. 27.
    Al-Safi Z, Shavell VI, Katz LE, Berman JM. Nickel hypersensitivity associated with an intratubal microinsert system. Obstet Gynecol. 2011;117(2, Part 2):461–2. Available from: http://www.ncbi.nlm.nih.gov/pubmed/21252789. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  28. 28.
    Hitzerd E, Schreuder HWR, Vleugels MPH, Veersema S. Twelve-year retrospective review of unintended pregnancies after Essure sterilization in the Netherlands. Fertil Steril. 2016;105(4):932–7. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0015028215023092. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  29. 29.
    Gerritse MBE, Veersema S, Timmermans A, Brölmann HAM. Incorrect position of Essure microinserts 3 months after successful bilateral placement. Fertil Steril. 2009;91(3):930.e1–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18945426. [Internet; Cited 22 Jan 2017].CrossRefGoogle Scholar
  30. 30.
    Hur H-C, Mansuria SM, Chen BA, Lee TT. Laparoscopic management of hysteroscopic essure sterilization complications: report of 3 cases. J Minim Invasive Gynecol. 2008;15(3):362–5. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18439513. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  31. 31.
    Legendre G, Varoux M, Nazac A, Fernandez H. Regret following hysteroscopic tubal sterilization. J Gynecol Obstet Biol Reprod (Paris). 2014;43(5):387–92. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24286930. [Internet; Cited 02 Feb 2017].CrossRefGoogle Scholar
  32. 32.
    Levy B, Levie MD, Childers ME, Kerin JF, Cooper JM, Price T, et al. A summary of reported pregnancies after hysteroscopic sterilization. J Minim Invasive Gynecol. 2007;14(3):271–4. Available from: http://www.ncbi.nlm.nih.gov/pubmed/17478354. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  33. 33.
    Jost S, Huchon C, Legendre G, Letohic A, Fernandez H, Panel P. Essure® permanent birth control effectiveness: a seven-year survey. Eur J Obstet Gynecol Reprod Biol. 2013;168(2):134–7.CrossRefPubMedGoogle Scholar
  34. 34.
    Fernandez H, Legendre G, Blein C, Lamarsalle L, Panel P. Tubal sterilization: pregnancy rates after hysteroscopic versus laparoscopic sterilization in France, 2006–2010. Eur J Obstet Gynecol Reprod Biol. 2014;180:133–7.CrossRefPubMedGoogle Scholar
  35. 35.
    Kerin JF, Cooper JM, Price T, Herendael BJ, Cayuela-Font E, Cher D, et al. Hysteroscopic sterilization using a micro-insert device: results of a multicentre Phase II study. Hum Reprod. 2003;18(6):1223–30. Available from: http://www.ncbi.nlm.nih.gov/pubmed/12773450. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  36. 36.
    Bahk CY, Goshgarian M, Donahue K, Freifeld CC, Menone CM, Pierce CE, et al. Increasing patient engagement in pharmacovigilance through online community outreach and mobile reporting applications: an analysis of adverse event reporting for the essure device in the US. Pharmaceut Med. 2015;29(6):331–40. Available from: http://link.springer.com/10.1007/s40290-015-0106-6. [Internet; Cited 22 Jan 2017].PubMedPubMedCentralGoogle Scholar
  37. 37.
    Valle RF, Carignan CS, Wright TC, Ross J, Schwartz D, Wingo P, et al. Tissue response to the STOP microcoil transcervical permanent contraceptive device: results from a prehysterectomy study. Fertil Steril. 2001;76(5):974–80. Available from: http://linkinghub.elsevier.com/retrieve/pii/S0015028201028588. [Internet; Cited 22 Jan 2017].CrossRefPubMedGoogle Scholar
  38. 38.
    Marcusson JA, Lindh G, Evengard B. Chronic fatigue syndrome and nickel allergy. Contact Dermatitis. 1999;40(5):269–72. Available from: http://doi.wiley.com/10.1111/j.1600-0536.1999.tb06061.x. [Internet; Cited 18 Jan 2017].CrossRefPubMedGoogle Scholar
  39. 39.
    Messer RLW, Wataha JC, Lewis JB, Lockwood PE, Caughman GB, Tseng W-Y. Effect of vascular stent alloys on expression of cellular adhesion molecules by endothelial cells. J Long Term Eff Med Implants. 2005;15(1):39–47. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15715515. [Internet; Cited 30 Jan 2017].CrossRefPubMedGoogle Scholar
  40. 40.
    Dasika UK, Kanter KR, Vincent R. Nickel allergy to the percutaneous patent foramen ovale occluder and subsequent systemic nickel allergy. J Thorac Cardiovasc Surg. 2003;126(6):2112. Available from: http://www.ncbi.nlm.nih.gov/pubmed/14688749. [Internet; Cited 30 Jan 2017].CrossRefPubMedGoogle Scholar
  41. 41.
    Regland B, Zachrisson O, Stejskal V, Gottfries CG. Nickel allergy is found in a majority of women with chronic fatigue syndrome and muscle pain—and may be triggered by cigarette smoke and dietary nickel intake. J Chronic Fatigue Syndr. 2001;8(1):57–65. Available from: http://www.tandfonline.com/doi/full/10.1300/J092v08n01_04. [Internet; Cited 18 Jan 2017].CrossRefGoogle Scholar
  42. 42.
    Sterzl I, Procházková J, Hrdá P, Bártová J, Matucha P, Stejskal VD, et al. Mercury and nickel allergy: risk factors in fatigue and autoimmunity. Neuro Endocrinol Lett. 1999;20:221–8.PubMedGoogle Scholar
  43. 43.
    Honari G, Ellis SG, Wilkoff BL, Aronica MA, Svensson LG, Taylor JS. Hypersensitivity reactions associated with endovascular devices. Contact Dermatitis. 2008;59(1):7–22. Available from: http://doi.wiley.com/10.1111/j.1600-0536.2008.01351.x. [Internet; Cited 30 Jan 2017].CrossRefPubMedGoogle Scholar
  44. 44.
    Tschernitschek H, Borchers L, Geurtsen W. Nonalloyed titanium as a bioinert metal—a review. J Prosthet Dent. 2006;96(1):12. Available from: http://linkinghub.elsevier.com/retrieve/pii/S002239130600076X. [Internet; Cited 30 Jan 2017].CrossRefGoogle Scholar
  45. 45.
    Siddiqi A, Payne AGT, De Silva RK, Duncan WJ. Titanium allergy: could it affect dental implant integration? Clin Oral Implants Res. 2011;22(7):673–80. Available from: http://doi.wiley.com/10.1111/j.1600-0501.2010.02081.x. [Internet; Cited 30 Jan 2017].CrossRefPubMedGoogle Scholar
  46. 46.
    Toronto Health Economic and Technology Assessment (THETA) Collaborative. Hysteroscopic tubal sterilization: a health economic literature review. Ont Health Technol Assess Ser. 2013;13(22):1–25. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24228085. [Internet; Cited 01 Feb 2017].Google Scholar

Copyright information

© Springer International Publishing AG 2018

Authors and Affiliations

  1. 1.Service de gynécologie-obstétriqueCentre Hospitalier de VersaillesLe ChesnayFrance

Personalised recommendations