Hostname: page-component-cd9895bd7-gxg78 Total loading time: 0 Render date: 2024-12-22T23:40:35.041Z Has data issue: false hasContentIssue false
  • English
  • Français

Fetal Repair of Open Neural Tube Defects: Ethical, Legal, and Social Issues

Published online by Cambridge University Press:  12 July 2019

JULIA A.E. RADIC ,
JUDY ILLES  and
PATRICK J. MCDONALD
Get access Rights & Permissions [Opens in a new window]

Abstract:

Open neural tube defects or myelomeningoceles are a common congenital condition caused by failure of closure of the neural tube early in gestation, leading to a number of neurologic sequelae including paralysis, hindbrain herniation, hydrocephalus and neurogenic bowel and bladder dysfunction. Traditionally, the condition was treated by closure of the defect postnatally but a recently completed randomized controlled trial of prenatal versus postnatal closure demonstrated improved neurologic outcomes in the prenatal closure group. Fetal surgery, or more precisely maternal-fetal surgery, raises a number of ethical issues that we address including who the patient is, informed consent, surgical innovation and equipoise as well maternal assumption of risk. As the procedure becomes more widely adopted into practice, we suggest close monitoring of new fetal surgery centers, in order to ensure that the positive results of the trial are maintained without increased risk to both the mother and fetus.

Keywords

myelomeningocelefetal surgerysurgical innovation
Type
Articles
Information
Cambridge Quarterly of Healthcare Ethics , Volume 28 , Issue 3 , July 2019 , pp. 476 - 487
Copyright
Copyright © Cambridge University Press 2019 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Notes

1. Lyerly, AD, Gates, EA, Cefalo, RC, Sugarman, J. Toward the ethical evaluation and use of maternal-fetal surgery. Obstetrics & Gynecology 2001;98(4):689–97.Google ScholarPubMed

2. Rodrigues, HC, van den Berg, PP. Randomized controlled trials of maternal-fetal surgery: A challenge to clinical equipoise. Bioethics 2014;28(8):405–13.CrossRefGoogle ScholarPubMed

3. Smajdor, A. Ethical challenges in fetal surgery. Journal of Medical Ethics 2011;37(2):88–91.CrossRefGoogle ScholarPubMed

4. Clewell, WH, Johnson, ML, Meier, PR, Newkirk, JB, Zide, SL, Hendee, RW, et al. A surgical approach to the treatment of fetal hydrocephalus. New England Journal of Medicine 1982;306(22):1320–5.CrossRefGoogle ScholarPubMed

5. Simpson, JL. Fetal surgery for myelomeningocele: Promise, progress, and problems. JAMA 1999;282(19):1873–4.CrossRefGoogle ScholarPubMed

6. Peranteau, WH, Adzick, NS. Prenatal surgery for myelomeningocele. Current Opinion Obstetrics and Gynecology 2016;28(2):111–8.CrossRefGoogle ScholarPubMed

7. Tulipan, N, Bruner, JP. Myelomeningocele repair in utero: A report of three cases. Pediatric Neurosurgery 1998;28(4):177–80.CrossRefGoogle ScholarPubMed

8. Adzick, NS, Thom, EA, Spong, CY, Brock, JW 3rd, Burrows, PK, Johnson, MP, et al. A randomized trial of prenatal versus postnatal repair of myelomeningocele. New England Journal of Medicine 2011;364(11):993–1004.CrossRefGoogle ScholarPubMed

9. Tulipan, N, Wellons, JC 3rd, Thom, EA, Gupta, N, Sutton, LN, Burrows, PK, et al. Prenatal surgery for myelomeningocele and the need for cerebrospinal fluid shunt placement. Journal of Neurosurgery: Pediatrics 2015;16(6):613–20.Google ScholarPubMed

10. Brock, JW 3rd, Carr, MC, Adzick, NS, Burrows, PK, Thomas, JC, Thom, EA, et al. Bladder function after fetal surgery for myelomeningocele. Pediatrics 2015;136(4):e906–13.CrossRefGoogle ScholarPubMed

11. Pedreira, DA, Zanon, N, Nishikuni, K, Moreira de Sa, RA, Acacio, GL, Chmait, RH, et al. Endoscopic surgery for the antenatal treatment of myelomeningocele: The CECAM trial. American Journal of Obstetrics & Gynecology 2016;214(1):111 e1–e11.CrossRefGoogle ScholarPubMed

12. Johnson, MP, Naftnet. The North American Fetal Therapy Network (NAFTNet): A new approach to collaborative research in fetal diagnosis and therapy. Seminars in Fetal and Neonatal Medicine 2010;15(1):52–7.CrossRefGoogle ScholarPubMed

13. Dickens, BM, Cook, RJ. Legal and ethical issues in fetal surgery. International Journal of Gynaecology & Obstetrics 2011;115(1):80–3.CrossRefGoogle ScholarPubMed

14. Lagercrantz, H. The emergence of consciousness: Science and ethics. Seminars in Fetal and Neonatal Medicine 2014;19(5):300–5.CrossRefGoogle Scholar

15. See note 14, Lagercrantz 2014.

16. See note 2, Rodrigues, van den Berg 2014.

17. Townsend, SF. Ethics for the pediatrician: Obstetric conflict: when fetal and maternal interests are at odds. Pediatrics in Review 2012;33(1):33–7.CrossRefGoogle ScholarPubMed

18. Antiel, RM, Adzick, NS, Thom, EA, Burrows, PK, Farmer, DL, Brock, JW 3rd, et al. Impact on family and parental stress of prenatal vs postnatal repair of myelomeningocele. American Journal of Obstetrics & Gynecology 2016;215(4):522 e1–6.CrossRefGoogle ScholarPubMed

19. See note 6, Peranteau, Adzick 2016.

20. Chervenak, FA, McCullough, LB. Ethics of fetal surgery. Clinics in Perinatology 2009;36(2):237–46, vii–viii.CrossRefGoogle ScholarPubMed

21. See note 20, Chervenak, McCullough 2009.

22. American College of Obstetricians and Gynecologists. Committee on Ethics, American Academy of Pediatrics.Committee on Bioethics. Committee opinion no. 501: Maternal-fetal intervention and fetal care centers. Obstetrics & Gynecology 2011;118(2 Pt 1):405–10.CrossRefGoogle Scholar

23. See note 13, Dickens, Cook 2011.

24. See note 17, Townsend 2012.

25. Chervenak, FA, McCullough, LB. Ethics of maternal-fetal surgery. Seminars in Fetal and Neonatal Medicine 2007;12(6):426–31.CrossRefGoogle ScholarPubMed

26. Lyerly, AD, Mahowald, MB. Maternal-fetal surgery: The fallacy of abstraction and the problem of equipoise. Health Care Analysis 2001;9(2):151–65.CrossRefGoogle ScholarPubMed

27. See note 26, Lyerly, Mahowald 2001.

28. See note 1, Lyerly et al. 2001.

29. See note 20, Chervenak, McCullough 2009.

30. Biffl, WL, Spain, DA, Reitsma, AM, Minter, RM, Upperman, J, Wilson, M, et al. Responsible development and application of surgical innovations: A position statement of the Society of University Surgeons. Journal of the American College of Surgeons 2008;206(6):1204–9.CrossRefGoogle ScholarPubMed

31. Barkun, JS, Aronson, JK, Feldman, LS, Maddern, GJ, Strasberg, SM, Balliol, C, et al. Evaluation and stages of surgical innovations. Lancet 2009;374(9695):1089–96.CrossRefGoogle ScholarPubMed

32. See note 22, American College of Obstetricians and Gynecologists. Committee on Ethics, American Academy of Pediatrics. Committee on Bioethics. 2011.

33. See note 6, Peranteau, Adzick 2016.

34. See note 11, Pedreira et al. 2016.

35. McCulloch, P, Altman, DG, Campbell, WB, Flum, DR, Glasziou, P, Marshall, JC, et al. No surgical innovation without evaluation: The IDEAL recommendations. Lancet 2009;374(9695):1105–12.CrossRefGoogle ScholarPubMed

36. See note 1, Lyerly et al. 2001.

37. Bakaniene, I, Prasauskiene, A, Vaiciene-Magistris, N. Health-related quality of life in children with myelomeningocele: a systematic review of the literature. Child: Care, Health and Development 2016;42(5):625–43.Google ScholarPubMed

38. See note 37, Bakaniene et al. 2016.

39. Internet source. Available at http://www.cardinalglennon.com/fetalcareinstitute/conditions/HeadSpine/Pages/spinabifidarepair.aspx. In: SSM Health; 2016. (last accessed 16 Dec 2018).

40. See note 9, Tulipan et al. 2015.

41. Menezes, P. Trial effect: the road from efficacy to effectiveness. Journal of Clinical Investigation 2012;2(5):443–5.CrossRefGoogle Scholar

42. Internet source. Available at http://www.cardinalglennon.com/fetalcareinstitute/conditions/HeadSpine/Pages/SpinaBifidaSurgeryDetailsData.aspx. In: SSM Health; 2016. (last accessed 16 Dec 2018)

43. Rosano, A, Del Bufalo, E, Burgio, A. [Socioeconomic status and risk of congenital malformations]. Epidemiologia e Prevenzione 2008;32(1):21–6.Google Scholar

44. Yang, J, Carmichael, SL, Canfield, M, Song, J, Shaw, GM, National Birth Defects Prevention S. Socioeconomic status in relation to selected birth defects in a large multicentered US case-control study. American Journal Epidemiology 2008;167(2):145–54.CrossRefGoogle Scholar

45. Cohen, AR, Couto, J, Cummings, JJ, Johnson, A, Joseph, G, Kaufman, BA, et al. Position statement on fetal myelomeningocele repair. American Journal of Obstetrics & Gynecology 2014;210(2):107–11.CrossRefGoogle ScholarPubMed

46. See note 6, Peranteau, Adzick 2016.

47. See note 12, Johnson, Naftnet 2010.

48. Antiel, RM, Collura, CA, Flake, AW, Johnson, MP, Rintoul, NE, Lantos, JD, et al. Physician views regarding the benefits and burdens of prenatal surgery for myelomeningocele. Journal of Perinatology 2017.CrossRefGoogle ScholarPubMed

49. Heuer, GG, Moldenhauer, JS, Scott Adzick, N. Prenatal surgery for myelomeningocele: Review of the literature and future directions. Child’s Nervous System 2017;33(7):1149–55.CrossRefGoogle ScholarPubMed

50. Chang, SL, Jiang, W, Chung, BI. Trends in the adoption of robotic technology in the surgical management of prostate cancer: A population-based analysis. Journal of Clinical Oncology 2012;30(5_suppl):258.CrossRefGoogle Scholar

51. Kofler, M, Stastny, L, Reinstadler, SJ, Dumfarth, J, Kilo, J, Friedrich, G, et al. Robotic versus conventional coronary artery bypass grafting: Direct comparison of long-term clinical outcome. Innovations (Philadelphia, Pa.) 2017;12(4):239–46.CrossRefGoogle ScholarPubMed

52. Miller, BA, Salehi, A, Limbrick, DD Jr., Smyth, MD. Applications of a robotic stereotactic arm for pediatric epilepsy and neurooncology surgery. Journal of Neurosurgery: Pediatrics 2017:1–7.Google ScholarPubMed

53. Harada, K, Enosawa, S, Zhang, B, Yuan, W, Chiba, T, Fujie, MG. Evaluation of fetal tissue viscoelastic characteristics for robotic fetal surgery. International Journal of Computer Assisted Radiology and Surgery 2011;6(6):797–802.CrossRefGoogle ScholarPubMed

54. Zhang, B, Kobayashi, Y, Chiba, T, Fujie, MG. Robotic patch-stabilizer using wire driven mechanism for minimally invasive fetal surgery. Conference proceedings : … Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2009;2009:5076–9.Google ScholarPubMed

55. Vanover, M, Wang, A, Farmer, D. Potential clinical applications of placental stem cells for use in fetal therapy of birth defects. Placenta 2017.CrossRefGoogle ScholarPubMed

56. Kajiwara, K, Tanemoto, T, Wada, S, Karibe, J, Ihara, N, Ikemoto, Y, et al. Fetal therapy model of myelomeningocele with three-dimensional skin using amniotic fluid cell-derived induced pluripotent stem cells. Stem Cell Reports 2017;8(6):1701–13.CrossRefGoogle ScholarPubMed

57. See note 12, Johnson, Naftnet 2010.

58. See note 35, McCulloch et al. 2009.