title: 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
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors: Department of Gynaecology and Obstetrics, University Hospital Heidelberg, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany, Sarah.Schott@med.uni-heidelberg.de.
authors: Sarah
authors: S
authors: Schott
authors: Thomas
authors: T
authors: Bruckner
authors: Florian
authors: F
authors: Schütz
authors: Markus
authors: M
authors: Wallwiener
authors: Christof
authors: C
authors: Sohn
authors: Michael
authors: M
authors: Golatta
authors: Joerg
authors: J
authors: Heil
mesh_terms: D000328:Adult; D000368:Aged; D001007:Anxiety / Q000209:etiology / Q000523:psychology; D019928:Breast Implantation / Q000009:adverse effects* / Q000523:psychology; D018427:Breast Implants / Q000009:adverse effects / Q000523:psychology*; D001943:Breast Neoplasms / Q000534:rehabilitation / Q000601:surgery*; D020878:Device Removal / Q000523:psychology*; D004954:Esthetics; D005260:Female; D006801:Humans; D057052:Medical Device Recalls; D008875:Middle Aged; D011446:Prospective Studies; D011475:Prosthesis Failure; D011788:Quality of Life / Q000523:psychology*; D012828:Silicones; D011795:Surveys and Questionnaires
chemical_list: D012828:Silicones