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.
- 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.