FDA updates reported harmful events linked to breast implants
https://www.facingourrisk.org/XRAY/new-updates-on-breast-implant-cancer-risk
Full article: https://www.fda.gov/news-events/press-announcements/fda-updates-analysis-medical-device-reports-breast-implant-illness-and-breast-implant-associated
The FDA has updated reported cases of breast implant-associated cancer and breast implant illness. Included in this update is approval of a questionnaire that asks about quality of life and satisfaction with breast implants. (10/20/20). Note: On October 27, 2021 the FDA announced stronger guidance on breast implant safety.
Questions To Ask Your Health Care Provider
- How often should I see a board-certified plastic surgeon, even if I have no concerns about my breast implants?
- How often should I have an MRI to evaluate the integrity of my silicone breast implants?
- How can I obtain a copy of the manufacturer’s safety information for the implants I have or I am considering?
- Regarding the breast implants I have or I am considering, how long can I expect to have them before they need to be replaced?
- Can you help me complete the BREAST-Q Reconstruction Module?
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.