FDA asks Allergan to recall certain textured breast implants
https://www.facingourrisk.org/XRAY/FDA-recall-Allergen-BIOCELL-textured-breast-implants
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 studies are related to mastectomy and breast reconstruction.
- NCT05720039: Nipple-Sparing Mastectomy With Immediate Implant-Based Reconstruction for Women With Early-Stage Breast Cancer. This study will compare robotic-assisted nipple-sparing mastectomy (NSM) to standard surgery NSM for women with early-stage breast cancer.
- NCT02918474: Decision-Making Tool in Supporting Decision-Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer. This trial studies the acceptability and usefulness of a tool that supports decision-making for contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer.
- NCT05020574: Microbiome and Association With Implant Infections. This 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.