Clinical Improvement after ESSURE® devices removal, a systematic review
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The systematic review examines clinical improvement following the removal of Essure® devices due to reported side effects, with studies suggesting that 73% to 98% of patients experience some level of improvement in symptoms and quality of life post-explantation. The underlying mechanisms for these symptoms may involve the release of toxic metal elements, yet the studies included are largely retrospective and heterogeneous. A call for more prospective, long-term studies is made to better understand the efficacy of removal and manage patients with unresolved symptoms.
Clinical Improvement after ESSURE® devices removal, a systematic review
- 1. Clinical Improvement after ESSURE® devices removal: a systematic review Chloé Miguet-Bensouda¹-², François Parant¹, Gautier Chene² ¹ Trace Element Analysis Laboratory, Biochemistry Department, University Hospital of Lyon ² Department of Gynecology, Hôpital Femme Mère Enfant, University Hospital of Lyon Introduction Essure® implant is a permanent minimally invasive control birth device implanted to 750000 patients worldwide between 2002 and 2018. Many side-effects were reported by patients. Essure®-related-symptoms were both local signs (pelvic pain, heavy menstrual bleeding (HMB), dyspareunia…) and general signs (asthenia, arthralgia, cognitive impairment…). Possible corrosion of the implant may be suggested with release of toxic metal elements such as nickel, chromium and tin in surrounding tissues and peritoneal fl uid of symptomatic patients1-2. Increasingly explantation surgery are realized in symptomatic patients. However, strong studies about clinical improvement after removal are missing. 14. Arjona. J. Obstet. Gynecol. 2014 15. Casey. Contraception. 2016 16. Casey. J. Minim. Invasive Gynecol. 2017 17. Chene. Europ. J. Obstet. Gynecol. Reprod. Biol. 2019 18. Francini. J. Gynecol. Obstet. Hum. Reprod. 2021 19. Cassidy. Survey. 2019 20. Chauhan. Autoimmun. Rev. 2021 21. bayer.com. IFU. 2016 6. Leleu. J. Gynecol. Obstet. Hum. Reprod. 2021 7. Merviel. Minerva Ginecol. 2019 8. Siemons, Fertil. Steril. 2019 9. van Drongelen. RIVM Lett. Rep. 2016-006. 2016 10. Eychenne. J. Gynecol. Obstet. Hum. 2021 11. Clark. J. Minim. Invasive Gynecol. 2017 12. Nolan. J. Robot. Surg. 2021 13. Brito. J. Minim. Invasive Gynecol. 2015 1. Parant. Eur. J. Obstet. Gynecol. Reprod. 2022 2. Catinon. J. Trace Elem. Med. Biol. 2022 3. medscape.com, sante-sur-le-net.com 4. Jegaden. J. Gynecol. Obstet. Hum. Reprod. 2020 5. Maassen. J. Minim. Invasive Gynecol. 2019 Removal of Essure® in symptomatic patients may improve symptoms and quality of life. The pathophysiological mechanisms underlying Essure®-attributed-symptoms remains unclear, but could probably be related to release of metallic elements. Managing patients without any improvement of symptomatology remain a challenge. Furthermore, studies are heterogenous and often retrospective so a prospective study with long time follow-up is needed. ‣ Literature search 18 studies were included from 2014 to January 2022, among which only 2 were prospective studies. Design and outcomes were heterogenous. ‣ Patients & technique of removal We collected informations about 981 explanted patients of which 922 with clinical follow- up. Technique of explantation were hysterectomy (36%), cornuectomy (28%), salpingectomy (26%), hysteroscopy (<1%), or unspeci fi ed (9%). Clinical assessment was mostly collected a few weeks after surgery. ‣ Global improvement Clinical improvement, at least partial, was reported from 73% to 98% of patients (Table 1). Time a ft er surgery (months) Improvement No improvement (%) Worsening (%) Total or almost total (%) Par ti al (%) Jegaden4 (n=90) 1 to 2 24 47 83 51 2 - Maasen5 (n=73) 1.5 40 45 15 - Leleu (n=57) 1.5 to 2 33 60 7 - Merviel7 (n=52) 1, 3 and 6 21 Siemons8 (n=51) 3 57 van Drongelen9 (n=49) Unspeci fi ed 29 59 12 - Eychenne10 (n=90) (n=82) 2 6 91 98 8 1 1 1 Clark11 (n=32) 1 87 Nolan12 (n=19) 1 89 Brito13 (n=11) Unspeci fi ed (un ti l 4 years) 73 9 18 Materials and methods Results Conclusion References 3 studies assessed prevalence of pelvic pain resolution after removal of device without mentioning other Essure®-attributed symptoms. In a large case series including 4 274 women, Arjona14 reported 7 patients requiring device removal for chronic pelvic pain. Pain disappeared in all cases after surgery and until 6 months follow-up. In 2016, Casey15 reported resolution for 88,5% of explanted patients (23/26). In 2017, Casey16 reported pain resolution for 78% of patients (32/41) at the post-operative visit. Table 1: Studies evaluating global improvement after Essure® removal: rates of patient with “improvement”, “no improvement” and “worsening situation”. ‣ Pain ✦ Pelvic pain ✦ Pain score Pain was signi fi cantly improved after surgery regardless the scales used by authors (Table 2). Endpoint Time a ft er removal (month) VAS before (/10) VAS a ft er (/10) Chene17 (n=80) Global pain 1 - 3 - 6 3.6 1.4* - 0.8* - 1.5 Nolan12 (n=19) Global pain 1 8,5 0.75* Ca ti non2 (n=17) Pelvic pain 3 4,9 1.9* Table 2: Studies assessing pain score before and after removal. VAS: Visual Analogic Scale. * p<.05 compared to VAS before removal ‣ Essure®-attributed-symptoms After Essure® removal, signi fi cant improvement ranged from 65% to 100% of patients depending on studies. Mean QoL scores were also improved (table 3). Used score Time a ft er removal Rate of pa ti ent with improvement of QoL (%) Mean QoL score Before A ft er Francini18 (n=83) SF-36 3 months For PCS: 80 For MCS: 83 For PCS + MCS: 71 Clark11 (n=32) 1 month 75 Brito13 (n=11) Un ti l 4 years 82 Cassidy19 (n=86) Score 0-5 Un ti l 4 years 98 1.4 / 5 4.2 / 5 Chene17 (n=80) SF-12 1-3-6 months 58 - 65 - 65 MCS: 34 PCS: 36 49* - 53* - 50* 43* - 44* - 48* Nolan12 (n=19) Score 0-7 1 month 5.9 / 7 1.5 / 7* Table 3: Studies assessing evolution of QoL after Essure® removal for device-attributed- Figure 1: Prevalence of Essure®-attributed- symptoms before and after removal of device combining data from 8 studies. * p<.05, ** p<.001 3 A review of English literature was conducted using PubMed and Embase databases. Single cases reports and abstracts without detailed article were excluded. Data were synthesized under following categories: global improvement, pain, prevalence of Essure®-attributed symptoms, and quality of life (QoL). Statistical analysis were realized by Fisher’s exact test. ‣ Quality of life Bonne version lequotidiendumedecin.fr Essure® implant21 symptoms. * p<.05 vs «before» PCS: Physical Component Scale. MCS: Mental Component Scale. Essure® implant3 10 studies2,5-7,10-11,13,18-20 described prevalence of Essure® -related-symptoms before explantation and evolution a few weeks after surgery. 2 of them13,20 were excluded from this chapter to avoid the risk of sampling bias due to potential overlapping populations. Figure 1 combine data from the 8 remaining studies. Local symptoms trended to have a better rate of improvement than general symptoms. After exclusion of symptoms like “HMB” that necessarily were improved by hysterectomies, local symptoms with better rate of improvement were “dyspareunia”, “digestive disorder” and “abdominal or pelvic pain” (91%, 82% and 76%, respectively) (p<.001). General symptoms with better rate of i m p r ove m e n t w e r e “depressive syndrome», “dermatologic issue” and “pruritus” (87%, 8 5 % a n d 7 7 % , respectively) (p<.05).