FDA asks Allergan to recall certain textured breast implants
https://www.facingourrisk.org/XRAY/FDA-recall-Allergen-BIOCELL-textured-breast-implants
Full article: https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan
On July 25, 2019, the Food and Drug Administration requested that breast implant manufacturer Allergan recall its BIOCELL textured implants and expanders due to an association with a rare type of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL. The FDA does not recommend removing implants for people who do not have disease symptoms. This XRAYS review updates information about this FDA recall. (7/29/19)
Questions To Ask Your Health Care Provider
- What are the pros and cons of breast implants?
- What are the pros and cons of textured and smooth breast implants?
- What are the BIA-ALCL symptoms that I should be aware of after I get breast implants?
- I had surgery years ago. How can I find out what type of implants I have?
- I have BIOCELL implants, what are the pros and cons of having them removed?
- I have BIOCELL implants and want to have them removed, will my insurance pay for it?
- What breast reconstruction options do not involve implants?
- What factors should I consider when deciding between different breast reconstruction options?
- What type of follow up should I have after mastectomy and reconstruction? Should I have breast MRI? If so, how frequently? Will my insurance pay for these follow-ups?
Open Clinical Trials
The following are studies related to breast reconstruction or no reconstruction after mastectomy.
- NCT04533373: Sensory Restoration After DIEP Flap Neurotization. The goal of this study is to look at how well a nerve graft works for improving sensation to the reconstructed breast after mastectomy in people undergoing DIEP flap reconstruction.
- NCT04491591: Implementing BREASTChoice Into Practice. Breast reconstruction after mastectomy is a highly personal decision. A clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. This study will evaluate whether BREASTChoice assists reconstruction decisions.
- NCT04293146: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC. This study will compare the effect of under-the-muscle versus over-the-muscle reconstruction on quality-of-life outcomes.
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NCT05020574: Microbiome and Association With Implant Infections. The study is looking at whether people with high amounts of certain types of bacteria are more likely to develop tissue expander-related infections than those with lower amounts of bacteria.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.