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 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.
- NCT04533373: Sensory Restoration After DIEP Flap Neurotization. The goal of this study is to look at whether nerve graft works to improve sensation in the breast after mastectomy with DIEP flap reconstruction.
-
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.