Impact of the Poly Implant Prosthesis Breast Implants Recall in Women With Breast Reconstruction: A South-Eastern French Cross-Sectional Survey Nested in a Prospective Cohort
DOI:
https://doi.org/10.17140/WHOJ-1-111Keywords:
Breast implants; Breast Reconstruction; Psychosocial outcomes; PIP implants; Decisional regret; Satisfaction.Abstract
The Poly Implant Prosthesis (PIP) Breast Implants crisis involved thousands of women in the countries concerned, women with breast cancer in particular. It was proposed here to
investigate the impact of the PIP Breast Implants recall on women who had undergone Breast
Reconstruction at the time of the recall and to analyze the determinants of their Breast Reconstruction decisional outcomes. A cross-sectional telephone survey was performed nested in prospective geographically based cohorts, which consisted of women from the southeastern France
with breast cancer. Women were selected who had Breast Reconstructive surgery just before
the PIP recall occurred. Dependent variables were the Psychological Impact of the event, Decisional Regret, and Satisfaction with Breast Reconstruction. Determinants of regret and satisfaction were analyzed using simultaneous equations. Among the 148 eligible women, 113(76%)
participated. At the initial reconstruction, 90% (n=102) had a Breast Implant, 10% (n=11) had
an autologous reconstruction. The PIP recall induced less intrusive thoughts, measured with the
Impact of the Event Scale, in the non-PIP groups compared to the PIP one (p=0.025). Regrets
about Breast Reconstruction were expressed by 57%; they occurred more frequently when the
decision-making was not felt to be sufficiently proactive (adjusted Odds Ratio (ORadj) 5.1;
95% Confidence Interval (CI) (1.2-20.9)) and in those who were dissatisfied with their Breast
Reconstruction (ORadj 0.7(95% CI (0.5-0.9))). Satisfaction was significantly lower in women
with a Breast Implant, those whose trust in doctors had decreased, in the information-seekers
and in less health-literate women. The PIP recall was not found to affect intrusive ideas or
denial in women who did not have a PIP Breast Reconstruction. The high frequency of regrets
could be reduced by involving women more strongly in the initial decision-making process.
Using existing data-bases to assess the impact of new devices on patients’ health is an option
which organization deserves to be discussed.
References
Jagsi R, Jiang J, Momoh AO, et al. Trends and variation in use of breast reconstruction in patients with breast cancer undergo-ing mastectomy in the United States. J Clin Oncol. 2014; 32(9): 919-926. doi: 10.1200/JCO.2013.52.2284
Brennan ME, Spillane AJ. Uptake and predictors of post-mastectomy reconstruction in women with breast malignancy-systematic review. Eur J Surg Oncol. 2013; 39(6): 527-541. . doi: 10.1016/j.ejso.2013.02.021
Albornoz CR, Bach PB, Mehrara BJ, et al. A paradigm shift in U.S. Breast reconstruction: increasing implant rates. Plast Reconstr Surg. 2013; 131(1): 15-23. doi: 10.1097/ PRS.0b013e3182729cde
Gerszten PC. A formal risk assessment of silicone breast im-plants. Biomaterials. 1999; 20(11): 1063-1069. doi: 10.1016/ S0142-9612(99)00008-3
Berry MG, Stanek JJ. PIP silicone breast implants. J Plast Reconstr Aesthet Surg. 2014; 67(1): 127-128.
Berry MG, Stanek JJ. The PIP mammary prosthesis: a product recall study. J Plast Reconstr Aesthet Surg. 2012; 65(6): 697- 704. doi: 10.1016/j.bjps.2012.02.019
Heneghan C. The saga of poly implant prosthese breast im-plants. BMJ. 2012; 344: e306. doi: 10.1136/bmj.e306
Latham M. If it ain’t broke, don’t fix it?: scandals, risk, and cosmetic surgery regulation in the Uk and France. Med Law Rev. 2014; 22(3): 384-408. doi: 10.1093/medlaw/fwt033
Parvizi N, Woods K. Regulation of medicines and medical devices: contrasts and similarities. Clin Med. 2014; 14(1): 6-12. doi: 10.7861/clinmedicine.14-1-6
Torjesen I. Intact PIP implants do not need to be removed, European report confirms. BMJ. 2013; 347: f6567. doi: 10.1136/ bmj.f6567
Wazir U, Kasem A, Mokbel K. The clinical implications of poly implant prothese breast implants: an overview. Arch Plast Surg. 2015; 42(1): 4-10. doi: 10.5999/aps.2015.42.1.4
Greco C. The poly implant prothese breast prostheses scan-dal: embodied risk and social suffering. Soc Sci Med. 2015; 147: 150-157. doi: 10.1016/j.socscimed.2015.10.068
Cluze C, Retornaz F, Rey D, et al. Inequality in sentinel lymph node dissection for elderly women with early stage breast cancer: results from a French prospective cohort study. Jour-nal of Geriatric Oncology. 2012; 3: 212-219. doi: 10.1016/j. jgo.2012.02.009
Cluze C, Rey D, Huiart L, et al. Adjuvant endocrine therapy with tamoxifen in young women with breast cancer: determi-nants of interruptions vary over time. Annals of oncology: of-ficial journal of the European Society for Medical Oncology/ ESMO. 2012; 23: 882-890. doi: 10.1093/annonc/mdr330
Huiart L, Bouhnik A-D, Rey D, et al. Complementary or alternative medicine as possible determinant of decreased per-sistence to aromatase inhibitor therapy among older women with non-metastatic breast cancer. PloS One. 2013; 8: e81677. doi: 10.1371/journal.pone.0081677
Huiart L, Bouhnik A-D, Rey D, et al. Early discontinuation of tamoxifen intake in younger women with breast cancer: is it time to rethink the way it is prescribed? European Journal of Cancer. 2012; 48: 1939-1946. doi: 10.1016/j.ejca.2012.03.004
Julian-Reynier C, Bouhnik AD, Mouret-Fourme E, et al. Time to prophylactic surgery in BRCA1/2 carriers depends on psychological and other characteristics. Genet Med. 2010; 12(12): 801-807. doi: 10.1097/GIM.0b013e3181f48d1c
Streiner D, Norman G. Health Measurement Scales. 2nd ed. Oxford: Oxford Medical Publications, 1999: 231.
Horowitz M, Wilner N, Alvarez W. Impact of event scale: a measure of subjective stress. Psychosom Med. 1979; 41(3): 209-218.
Degner LF, Sloan JA. Decision making during serious ill-ness: what role do patients really want to play? J Clin Epidemiol. 1992; 45(9): 941-950.
Pieterse AH, Baas-Thijssen MC, Marijnen CA, Stiggelbout AM. Clinician and cancer patient views on patient participa-tion in treatment decision-making: a quantitative and qualitative exploration. Br J Cancer. 2008; 99(6): 875-882. doi: 10.1038/ sj.bjc.6604611
Legare F, Kearing S, Clay K, et al. Are you SURE?: assess-ing patient decisional conflict with a 4-item screening test. Can Fam Physician. 2010; 56(8): e308-e314.
Zwaenepoel L, Bilo R, De Boever W, et al. Desire for in-formation about drugs: a survey of the need for information in psychiatric in-patients. Pharm World Sci. 2005; 27(1): 47-53. doi: 10.1007/s11096-005-4696-z
Brehaut JC, O’Connor AM, Wood TJ, et al. Validation of a decision regret scale. Med Decis Making. 2003; 23(4): 281-292.
Davidson R, Mac Kinnon JG. Estimation and inference in econometrics. New York: Oxford University Press; 1993.
Avery G. Endogeneity in logistic regression models. Emerg Infect Dis. 2005; 11(3): 503-504. doi: 10.3201/eid1103.050462
Anderson RC, Larson DL. Reconstruction and augmentation patients’ reaction to the media coverage of silicone gel-filled im-plants: anxiety evaluated. Psychol Rep. 1995; 76(3 Pt 2): 1323- 1330. doi: 10.2466/pr0.1995.76.3c.1323
Ho AL, Klassen AF, Cano S, Scott AM, Pusic AL. Optimiz-ing patient-centered care in breast reconstruction: the impor-tance of preoperative information and patient-physician com-munication. Plast Reconstr Surg. 2013; 132(2): 212e-220e. doi: 10.1097/PRS.0b013e31829586fa
Alderman AK, Wilkins EG, Lowery JC, Kim M, Davis JA. Determinants of patient satisfaction in postmastectomy breast reconstruction. Plast Reconstr Surg. 2000; 106(4): 769-776.
Sheehan J, Sherman KA, Lam T, Boyages J. Association of information satisfaction, psychological distress and monitoring coping style with post-decision regret following breast recon-struction. Psychooncology. 2007; 16(4): 342-351.
Griggs JJ, Sorbero ME, Mallinger JB, et al. Vitality, men-tal health, and satisfaction with information after breast can-cer. Patient Educ Couns. 2007; 66(1): 58-66. doi: 10.1016/j. pec.2006.10.008
Zhong T, Hu J, Bagher S, et al. Decision regret following breast reconstruction: the role of self-efficacy and satisfaction with information in the preoperative period. Plast Reconstr Surg. 2013; 132(5): 724e-734e. doi: 10.1097/PRS.0b013e3182a3bf5d
Fernandes-Taylor S, Bloom JR. Post-treatment regret among young breast cancer survivors. Psychooncology. 2011; 20(5): 506-516. doi: 10.1002/pon.1749
Platt J, Baxter N, Jones J, et al. Pre-consultation educa-tional group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013; 14: 199. doi: 10.1186/1745-6215-14-199
Winters ZE, Benson JR, Pusic AL. A systematic review of the clinical evidence to guide treatment recommendations in breast reconstruction based on patient- reported outcome mea-sures and health-related quality of life. Ann Surg. 2010; 252(6): 929-942. doi: 10.1097/SLA.0b013e3181e623db
Harcourt D, Griffiths C, Baker E, Hansen E, White P, Clarke A. The acceptability of PEGASUS: an intervention to facilitate shared decision-making with women contemplating breast re-construction. Psychol Health Med. 2015: 1-6.
Sivell S, Edwards A, Manstead AS, et al. Increasing readi-ness to decide and strengthening behavioral intentions: evaluat-ing the impact of a web-based patient decision aid for breast cancer treatment options. Patient Educ Couns. 2012; 88(2): 209- 217. doi: 10.1016/j.pec.2012.03.012
Sun CS, Cantor SB, Reece GP, et al. Helping patients make choices about breast reconstruction: a decision analysis approach. Plast Reconstr Surg. 2014; 134(4): 597-608. doi: 10.1097/PRS.0000000000000514
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
All content published in Women's Health (WH) is licensed under the Creative Commons Attribution 4.0 International License (CC BY 4.0). This license allows anyone to copy, distribute, transmit, and adapt the work — including for commercial purposes — provided appropriate credit is given to the original author(s) and source.
