Top

Archives of Gynecology and Obstetrics

Published in:

01-11-2014 | General Gynecology

Quality of life and anxiety of patients affected by the PIP/Rofil Medical breast implant recall: results from a prospective monocentre cohort study

Authors: Sarah Schott, Thomas Bruckner, Florian Schütz, Markus Wallwiener, Christof Sohn, Michael Golatta, Joerg Heil

Published in: Archives of Gynecology and Obstetrics | Issue 5/2014

Abstract

Background

The PIP/Rofil Medical breast implant recall affected around 40,000 women worldwide. An impact on quality of life (QoL) has been suspected but not yet reported.

Objective

To quantify QoL and anxiety in affected women with respect to implant indication and their removal.

Patients and methods

Women who attended consultation and opted for implant removal between December 2011 and 2012 were eligible for study. Quality of life and anxiety were measured using validated questionnaires pre- and postoperatively.

Results

Fifty-five patients completed at least one questionnaire, of which 32 had received implants for breast cancer, 15 for aesthetic augmentation, and 8 for primary breast malformations. Removal of the implants improved QoL in every group, especially those who had malformations. The QoL of breast cancer patients was generally better compared to the patients with implant for other reasons.

Conclusion

The recall of PIP/Rofil Medical breast implants had a measurable impact on QoL in affected women and no pathological worry was measurable among those women.

Reyal F et al (2013) The impact of poly implant prothese fraud on breast cancer patients: a report by the institut curie. Plast Reconstr Surg 131(4):690–695PubMedCrossRef

Manickavasagar T, Morritt AN, Offer GJ (2013) Bilateral supraclavicular swelling: an unusual presentation of ruptured Poly Implant Prosthese (PIP) breast implants. J Plast Reconstr Aesthet Surg 66(2):267–269PubMedCrossRef

Afssaps (2014) Update of recommendations for women with silicone filled Poly Implant Prosthesis (PIP) breast implants. http://ansm.sante.fr/var/ansm_site/storage/original/applicationea94f5f3532f4f831d6a923ef553a77e.pdf, accessibility verified, 1–30

Lampert FM, Schwarz M, Grabin S, Stark GB (2012) The “PIP scandal”—complications in breast implants of inferior qulaity : state of knowledge, offical recommendations and case report. Geburtsh Frauenheilk 72:243–246CrossRef

Freshwater MF (2012) The PIP crisis: deja vu all over again? J Plast Reconstr Aesthet Surg 65(6):840–843PubMedCrossRef

Zuckerman D, Booker N, Nagda S (2012) Public health implications of differences in US and European Union regulatory policies for breast implants. Reprod Health Matters 20(40):102–111PubMedCrossRef

O’Dowd A (2012) Women have had “harrowing” experiences over PIP implants scandal. BMJ 345:e4560PubMedCrossRef

Nano MT et al (2005) Psychological impact and cosmetic outcome of surgical breast cancer strategies. ANZ J Surg 75(11):940–947PubMedCrossRef

Roth RS et al (2005) Quality of life and affective distress in women seeking immediate versus delayed breast reconstruction after mastectomy for breast cancer. Plast Reconstr Surg 116(4):993–1002 (Discussion 1003–1005)PubMedCrossRef

10.

McCarthy CM et al (2012) The magnitude of effect of cosmetic breast augmentation on patient satisfaction and health-related quality of life. Plast Reconstr Surg 130(1):218–223PubMedCrossRef

11.

Cordeiro PG (2008) Breast reconstruction after surgery for breast cancer. N Engl J Med 359(15):1590–1601PubMedCrossRef

12.

Bfarm (2014) Empfehlungen des BfArM für Patientinnen mit PIP-Brustimplantaten. http://www.bfarm.de/DE/Medizinprodukte/risikoerfassung/empfehlungen/PIP/_node.html, 2011 accessibility verified, 1–30

13.

Aaronson NK et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376PubMedCrossRef

14.

Fayers PM, Aaronson NK, Bjordal K, Groenvold M, Curran D, Bottomley A, on behalf of the EORTC Quality of Life Group (2001) The EORTC QLQ-C30 scoring manual, 3rd edn. European Organisation for Research and Treatment of Cancer, Brussels

15.

Stober J, Bittencourt J (1998) Weekly assessment of worry: an adaptation of the Penn State Worry Questionnaire for monitoring changes during treatment. Behav Res Ther 36(6):645–656PubMedCrossRef

16.

Layton C (1987) Questionnaire completion and response to the STAI A-State scale. Percept Mot Skills 65(1):26PubMedCrossRef

17.

Meyer TJ et al (1990) Development and validation of the Penn State Worry Questionnaire. Behav Res Ther 28(6):487–495PubMedCrossRef

18.

Stöber J (2002) PSWQ-PW: Penn State Worry Questionnaire-past week. Diagnostische Verfahren in der Psychotherapie. Brähler E, Schumacher J, Strauß B (eds), Hogrefe, Göttingen

19.

Salzer S et al (2009) Screening for generalized anxiety disorder in inpatient psychosomatic rehabilitation: pathological worry and the impact of depressive symptoms. Psychosoc Med 6:Doc02PubMedPubMedCentral

20.

Schott S et al (2014) Recall management of patients with Rofil Medical breast implants. J Plast Reconstr Aesthet Surg 67(7):939–945

21.

Heil J et al (2011) Change of aesthetic and functional outcome over time and their relationship to quality of life after breast conserving therapy. Eur J Surg Oncol 37(2):116–121PubMedCrossRef

22.

Han J et al (2010) Quality of life and satisfaction after breast cancer operation. Arch Gynecol Obstet 282(1):75–82PubMedCrossRef

23.

Arndt V et al (2008) Quality of life over 5 years in women with breast cancer after breast-conserving therapy versus mastectomy: a population-based study. J Cancer Res Clin Oncol 134(12):1311–1318PubMedCrossRef

24.

Koch L et al (2013) Quality of life in long-term breast cancer survivors—a 10-year longitudinal population-based study. Acta Oncol

25.

Metcalfe KA et al (2012) Changes in psychosocial functioning 1 year after mastectomy alone, delayed breast reconstruction, or immediate breast reconstruction. Ann Surg Oncol 19(1):233–241PubMedCrossRef

26.

Bengtson BP et al (2007) Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg 120(7 Suppl 1):40S–48SPubMedCrossRef

27.

Spear SL et al (2007) Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg 120(7 Suppl 1):8S–16S (discussion 17S–18S)PubMedCrossRef

28.

Collis N et al (2007) Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity. Plast Reconstr Surg 120(5):1401–1406PubMedCrossRef

29.

Berry MG, Stanek JJ (2012) The PIP mammary prosthesis: a product recall study. J Plast Reconstr Aesthet Surg 65(6):697–704PubMedCrossRef

30.

Handel N et al (2006) A long-term study of outcomes, complications, and patient satisfaction with breast implants. Plast Reconstr Surg 117(3):757–767 (Discussion 768–72)PubMedCrossRef

31.

Klee M, Groenvold M, Machin D (1997) Quality of life of Danish women: population-based norms of the EORTC QLQ-C30. Qual Life Res 6(1):27–34PubMedCrossRef

32.

Hjermstad MJ et al (1998) Using reference data on quality of life—the importance of adjusting for age and gender, exemplified by the EORTC QLQ-C30 (+3). Eur J Cancer 34(9):1381–1389PubMedCrossRef

33.

Fitzsimmons D et al (2005) Symptoms and quality of life in chronic pancreatitis assessed by structured interview and the EORTC QLQ-C30 and QLQ-PAN26. Am J Gastroenterol 100(4):918–926PubMedCrossRef

34.

Solvi AS et al (2010) Motivational factors and psychological processes in cosmetic breast augmentation surgery. J Plast Reconstr Aesthet Surg 63(4):673–680PubMedCrossRef

35.

Klassen AF et al (2009) Satisfaction and quality of life in women who undergo breast surgery: a qualitative study. BMC Womens Health 9:11PubMedCrossRefPubMedCentral

36.

Katipamula R et al (2009) Trends in mastectomy rates at the Mayo Clinic Rochester: effect of surgical year and preoperative magnetic resonance imaging. J Clin Oncol 27(25):4082–4088PubMedCrossRefPubMedCentral

Title: Quality of life and anxiety of patients affected by the PIP/Rofil Medical breast implant recall: results from a prospective monocentre cohort study
Authors: Sarah Schott
Thomas Bruckner
Florian Schütz
Markus Wallwiener
Christof Sohn
Michael Golatta
Joerg Heil
Publication date: 01-11-2014
Publisher: Springer Berlin Heidelberg
Published in: Archives of Gynecology and Obstetrics / Issue 5/2014
Print ISSN: 0932-0067
Electronic ISSN: 1432-0711
DOI: https://doi.org/10.1007/s00404-014-3326-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Quality of life and anxiety of patients affected by the PIP/Rofil Medical breast implant recall: results from a prospective monocentre cohort study

Abstract

Background

Objective

Patients and methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Objective

Patients and methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 5/2014

Adnexal masses: what is the role of ultrasonographic imaging?

Cerebral oedema following robotic surgery: a rare complication

Elective induction of labor in women with gestational diabetes mellitus: an intervention that modifies the risk of cesarean section

Retrospective comparative study of irinotecan and pegylated liposomal doxorubicin for platinum-resistant or -refractory epithelial ovarian and primary peritoneal carcinoma

Is there a relationship between endometrial polyps and obesity, diabetes mellitus, hypertension?

Calcitonin gene- and parathyroid hormone-related peptides in normotensive and preeclamptic pregnancies: a nested case–control study