Intrauterine vacuum-induced hemorrhage-control device for hemorrhage after myomectomy: a case report and review of the literature

Introduction

The Jada system (Jada) is a novel intrauterine vacuum-induced hemorrhage control device that was approved by the United States Food and Drug Administration (FDA) in year 2020 for control of postpartum hemorrhage (1). The device is placed into the uterine cavity and utilizes a low-level vacuum, which encourages myometrial contraction, resulting in constriction of vasculature and control of postpartum hemorrhage (2,3).

The Jada is particularly effective in control of postpartum hemorrhage due to uterine atony refractory to uterotonic medications (4,5). Its vacuum-induced tamponade effect functions in contrast to historically utilized intrauterine balloon devices, which curtailed bleeding through pressure applied directly onto the uterine cavity (6-11). Jada compared favorably to uterine balloon tamponade for control of postpartum hemorrhage due to atony in a recent retrospective cohort (3).

The concept of balloon tamponade has also previously been extended to gynecologic surgery (12). However, to the best of our knowledge, the Jada system has not yet been utilized for control of hemorrhage in this setting. We present a case of a patient who underwent an emergent vaginal myomectomy whose intraoperative post-myomectomy uterine bleeding was successfully managed with application of the Jada. We present this article in accordance with the CARE and Narrative Review reporting checklists (available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-55/rc).

Case presentation

The patient is a 39-year-old G6P4024 with a past medical history of hypertension and poorly-controlled type 2 diabetes who presented to the emergency room (ER) with complaints of heavy vaginal bleeding and abdominal pain. She was hospitalized 1 month prior for similar concerns, at which time she received several blood transfusions and underwent uterine artery embolization (UAE). She was given depo-provera prior to her discharge. In the ER, she remarked that her bleeding had never fully subsided after the UAE, and that 2 days after discharge home, she developed increasing pain and bleeding. She was saturating twelve adult diapers per day and began experiencing intermittent subjective fevers and chills 1 week prior to presentation. She also complained of a foul odor coming from her vaginal area and felt tissue protruding outside of her vagina as she was en route to the ER, some of which she manually removed.

Vitals on presentation included normal blood pressure, heart rate, oxygen saturation, respiratory rate, and temperature. Her physical exam was significant for a large, foul-smelling, tan-gray mass protruding through her labia (Figure 1). Pelvic exam revealed that the mass was prolapsing through a dilated cervix. Her labs were notable for white blood cell count of 31.6 bil/L, hemoglobin 9.5 g/dL, platelet count of 125 bil/dL, glucose 263 mg/dL, creatinine 1.00 mg/dL, and normal electrolytes. Pelvic ultrasound revealed a complex hyperechoic region measuring 8.5 cm × 5.9 cm × 5.9 cm with hypoechoic foci suggestive of gas. A computed tomography scan of the abdomen and pelvis characterized the mass as measuring 12.5 cm × 3.0 cm × 4.7 cm and similarly noted foci of air (Figure 2). The diagnosis of necrotic prolapsed uterine fibroid was made. Given the findings of significant leukocytosis and foci of gas within the fibroid, concern was raised for superimposed infection. Vancomycin, cefepime, and metronidazole were initiated and infectious disease was consulted. Internal medicine was also consulted for management of hyperglycemia. She was then counseled about and provided her consent for surgical management with exam under anesthesia and vaginal myomectomy with possible hysteroscopy, possible dilation and curettage, and possible exploratory laparotomy with total abdominal hysterectomy.

Figure 1 Prolapsing necrotic myoma.

Figure 2 Computed tomography scan of abdomen and pelvis. (A) Axial plane view. (B) Sagittal plane view. Asterisks indicate the prolapsing fibroid and the white arrows indicate air foci.

After uneventful induction of anesthesia, examination revealed an enlarged, mobile, 16-week sized uterus. Her cervix was 4 cm dilated and otherwise was grossly normal-appearing. The prolapsing necrotic uterine fibroid extended 5 cm beyond the introitus with two major stalks extending to the level of the right uterine isthmus. We diluted ten units of vasopressin in 200 mL of sterile saline, and injected 20 mL of the diluted vasopressin into the stalks. Blanching was appreciated in both stalks. We also injected the cervix with diluted vasopressin at the 10 o’clock and 2 o’clock positions with similar effect. An 0-polydioxanone Endoloop ligature device was passed around the prolapsed fibroid and secured at the base of the stalks. A Ligasure bipolar cautery device was then used to cauterize and amputate the stalks just distal to the Endoloop ligature. The uterine cavity was then gently curetted, yielding a moderate amount of pink and necrotic-appearing tissue. All specimens were sent to pathology.

Brisk bleeding was noted through the cervix. Bimanual massage was performed for 2 minutes with no improvement in bleeding. A Jada was then placed and activated, with rapid improvement in bleeding noted (Figure 3). The vagina was packed around and distal to the Jada. The patient was awoken from anesthesia without difficulty and transferred to the recovery unit before returning to her room.

Figure 3 Jada system. Each unit comes equipped with (A) the Jada device, (B) 50 cc syringe, (C) 500 cc normal saline bag, and (D) suction tubing.

On post-operative day (POD) #1, she reported feeling better compared to how she felt in the ER and her bleeding was minimal with the Jada active and in situ. Her vaginal packing was removed and no active bleeding was appreciated. The Jada was then removed and no significant bleeding was noted. Her antibiotic regimen was maintained per infectious disease’s recommendations, and she continued to undergo optimization of her blood glucose control.

On POD #2, she continued to symptomatically improve and experienced only minimal vaginal spotting. No growth was noted on blood cultures. She remained afebrile and her leukocytosis improved. Therefore, antibiotics were discontinued, and she was initiated on megestrol 20 mg twice daily. On POD #3 and POD #4, she felt well and her hemoglobin remained stable at 7.8 and 7.9 g/dL, respectively. She was cleared for discharge home with plans for short-term follow-up for counseling and placement of a long-acting reversible contraceptive device. Final pathology from her procedure revealed necrotic smooth muscle tissue with acute and chronic inflammatory cells consistent with necrotic leiomyomas; no malignancy was identified.

All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Helsinki Declaration (as revised in 2013). Informed consent was obtained from our patient to share this case report and the accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Discussion

Intrauterine vacuum-induced hemorrhage control devices are fairly new additions to the healthcare armamentarium. They currently are utilized in the management of postpartum hemorrhage, which remains a leading cause of maternal morbidity and mortality in the United States and around the world (13-15). They function through application of low-level intrauterine negative pressure to rapidly facilitate physiologic myometrial contraction, which subsequently constricts uterine blood vessel caliber and reduces uterine minute perfusion, ultimately stemming resultant blood loss (1,4). Intrauterine vacuum-induced hemorrhage control devices are being increasingly integrated across institutions given their role in reducing rates of adverse maternal outcomes (16).

The Jada is approved by the United States FDA to provide “control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted” (17). Studies supporting Jada’s approval, including the PEARLE study, noted a high success rate in controlling postpartum uterine bleeding within minutes of activation (4,18). A recent study examining Jada’s impact on vaginal and cesarean deliveries in real-world settings also confirmed its safety and efficacy (19). However, these studies did not examine applications beyond obstetrical hemorrhage. We believe this is the first case report to detail integration of the Jada into a benign gynecologic procedure.

Currently, no contraindications or warnings are explicitly listed against applications of the Jada to benign gynecologic cases (1). In our case, the Jada remained in situ for approximately 12 hours which is in line with the manufacturer’s precaution of the device not remaining in place for greater than 24 hours due to risk of adverse tissue reactions or infections. We further acknowledge that 3.7% of patients in the PEARLE study developed endometritis which should not be overlooked. The use of antibiotic prophylaxis in the setting of prolonged use of the Jada system is left to provider discretion (1). In our patient’s case, ongoing administration of broad-spectrum antibiotics likely mitigated her risk of intrauterine infection. This limits generalizability of any risk assessment for developing endometritis in patients undergoing benign gynecologic procedures where a Jada is utilized.

Another potential shortcoming of the application of the Jada to gynecologic surgery is the requirement that the cervix be 3 cm dilated in order for the device to be inserted (1). Many cases of prolapsing leiomyoma likely will present with 3 cm of cervical dilation. However, this degree of cervical dilation is not anticipated to be present in most other cases of heavy uterine bleeding during gynecologic surgery and, therefore, the Jada likely cannot not be safely used in those scenarios.

The current cost of Jada may also be prohibitive of liberal use in gynecologic surgery. While previous generations of intrauterine tamponade devices cost between less than $1 up to $400 United States dollar (USD), Jada reportedly costs private health clinics $1,000 USD (20,21). This fiscal note may impede implementation within resource-limited healthcare settings where devices such as the Jada might be particularly useful (11,22). Financial hurdles also will likely hinder efforts at global application and fuel continued concerns about equitable access to and delivery of quality care.

Conclusions

Our experience suggests that use of the Jada system may be considered as an additional tool for controlling abnormal uterine bleeding in gynecologic surgery for select patients. It may be of interest to formally pursue studies investigating the Jada’s applications in these cases.

Acknowledgments

Funding: None.

Footnote

Reporting Checklist: The authors have completed the CARE and Narrative Review reporting checklists. Available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-55/rc

Peer Review File: Available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-55/prf

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://gpm.amegroups.com/article/view/10.21037/gpm-23-55/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. All procedures performed in this study were in accordance with the ethical standards of the institutional and/or national research committee(s) and with the Helsinki Declaration (as revised in 2013). Informed consent was obtained from our patient to share this case report and the accompanying images. A copy of the written consent is available for review by the editorial office of this journal.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

References

1. D'Alton M, Rood K, Simhan H, et al. Profile of the Jada® System: the vacuum-induced hemorrhage control device for treating abnormal postpartum uterine bleeding and postpartum hemorrhage. Expert Rev Med Devices 2021;18:849-53. [Crossref] [PubMed]
2. Haslinger C, Weber K, Zimmermann R. Vacuum-Induced Tamponade for Treatment of Postpartum Hemorrhage. Obstet Gynecol 2021;138:361-5. [Crossref] [PubMed]
3. Gulersen M, Gerber RP, Rochelson B, et al. Vacuum-Induced Hemorrhage Control versus Uterine Balloon Tamponade for Postpartum Hemorrhage. J Obstet Gynaecol Can 2023;45:267-72. [Crossref] [PubMed]
4. D'Alton ME, Rood KM, Smid MC, et al. Intrauterine Vacuum-Induced Hemorrhage-Control Device for Rapid Treatment of Postpartum Hemorrhage. Obstet Gynecol 2020;136:882-91. [Crossref] [PubMed]
5. Liu LY, Nathan L, Sheen JJ, et al. Review of Current Insights and Therapeutic Approaches for the Treatment of Refractory Postpartum Hemorrhage. Int J Womens Health 2023;15:905-26. [Crossref] [PubMed]
6. Wright CE, Chauhan SP, Abuhamad AZ. Bakri balloon in the management of postpartum hemorrhage: a review. Am J Perinatol 2014;31:957-64. [Crossref] [PubMed]
7. Kellie FJ, Wandabwa JN, Mousa HA, et al. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev 2020;7:CD013663. [PubMed]
8. Suarez S, Conde-Agudelo A, Borovac-Pinheiro A, et al. Uterine balloon tamponade for the treatment of postpartum hemorrhage: a systematic review and meta-analysis. Am J Obstet Gynecol 2020;222:293.e1-293.e52. [Crossref] [PubMed]
9. Balki M, Wong CA. Refractory uterine atony: still a problem after all these years. Int J Obstet Anesth 2021;48:103207. [Crossref] [PubMed]
10. Püchel J, Sitter M, Kranke P, et al. Procedural techniques to control postpartum hemorrhage. Best Pract Res Clin Anaesthesiol 2022;36:371-82. [Crossref] [PubMed]
11. Phillips JM, Eppes C, Rodriguez M, et al. Traditional uterine tamponade and vacuum-induced uterine tamponade devices in obstetrical hemorrhage management. Am J Obstet Gynecol MFM 2023;5:100739. [Crossref] [PubMed]
12. Nishino K, Hayashi K, Chaya J, et al. Effective salvage of acute massive uterine bleeding using intrauterine balloon tamponade in a uterine adenomyosis patient on dienogest. J Obstet Gynaecol Res 2013;39:738-41. [Crossref] [PubMed]
13. Centers for Disease Control and Prevention. Four in 5 pregnancy-related deaths in the U.S. are preventable. 2022. Available online: https://www.cdc.gov/media/releases/2022/p0919-pregnancy-related-deaths.html#:~:text=More%20than%2080%25%20of%20pregnancy,identify%20recommendations%20to%20prevent%20future
14. World Health Organization. Maternal mortality. 2023. Available online: https://www.who.int/news-room/fact-sheets/detail/maternal-mortality
15. Jackson TL, Tuuli MG. Intrauterine Postpartum Hemorrhage-Control Devices. Obstet Gynecol 2023;142:1000-5. [Crossref] [PubMed]
16. Federspiel JJ, Eke AC, Eppes CS. Postpartum hemorrhage protocols and benchmarks: improving care through standardization. Am J Obstet Gynecol MFM 2023;5:100740. [Crossref] [PubMed]
17. Jada System. Instructions for Use. Available online: https://www.organon.com/product/usa/pi_circulars/j/jada/jada_system_ifu_blue_seal.pdf
18. Purwosunu Y, Sarkoen W, Arulkumaran S, et al. Control of Postpartum Hemorrhage Using Vacuum-Induced Uterine Tamponade. Obstet Gynecol 2016;128:33-6. [Crossref] [PubMed]
19. Goffman D, Rood KM, Bianco A, et al. Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device. Obstet Gynecol 2023;142:1006-16. [Crossref] [PubMed]
20. Vogel JP, Wilson AN, Scott N, et al. Cost-effectiveness of uterine tamponade devices for the treatment of postpartum hemorrhage: A systematic review. Int J Gynaecol Obstet 2020;151:333-40. [Crossref] [PubMed]
21. Clark M, MacDougall D. Vacuum-Induced Uterine Tamponade for Postpartum Hemorrhage: CADTH Horizon Scan. Ottawa: Canadian Agency for Drugs and Technologies in Health; 2022.
22. Ahmadzia HK, Thomas SM, Murtha AP, et al. Obstetric hemorrhage survey: Attitudes and practices of maternal-fetal medicine fellows. J Neonatal Perinatal Med 2016;9:133-7. [Crossref] [PubMed]