FDA updates report on risk of lymphoma from breast implants
https://www.facingourrisk.org/XRAY/updated-report-implants-and-lymphoma
Full article: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/ucm239995.htm
Note: On 07/25/19, the FDA announced a recall of Allergan BIOCELL textured implants and expanders, due to their association with BIA-ALCL. On October 27, 2021 the FDA announced stronger guidance on breast implant safety.
In March 2017, the Food and Drug Administration reported that patients with breast implants may be at increased risk for a rare type of lymphoma. This was covered in a previous XRAYS review. The FDA has continued to collect data since the first reported association in 2011. Recently, the agency released an update on the number of reported cases of breast implant-associated lymphoma and lifetime risk estimates for women with textured breast implants. (04/02/18)
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 symptoms should I look for after I get breast implants?
- What options for breast reconstruction do not involve implants?
- What factors should I consider when deciding between different breast reconstruction options?
- I am considering/have had a risk-reducing prophylactic mastectomy with breast implants. Should I be worried about developing BIA-ALCL?
- Should I have breast MRI after mastectomy and reconstruction with implants? If so, how frequently?
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.
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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.