Stronger guidance about breast implant safety
https://www.facingourrisk.org/XRAY/FDA-box-warning-for-breast-implants
Full article: https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants
The FDA issued new guidance for breast implants so that all people with breast implants have the appropriate information to understand and make decisions about their healthcare. Required features include box warning, patient decision checklist, guidelines for screening for implant ruptures and patient device cards. (posted 12/14/21)
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Questions To Ask Your Health Care Provider
- What are the risks and benefits of breast implants?
- What symptoms should I be aware of regarding my breast implants?
- How long will my breast implants last?
- Under what circumstances should I consider removing or replacing my breast implants?
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.