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Breast cancer implant study suggests links with illness but has serious flaws
https://www.facingourrisk.org/XRAY/concerns-about-complications-from-breast-implants
Full article: https://www.ncbi.nlm.nih.gov/pubmed/?term=Coroneos+CJ%2C+Selber+JC%2C+Offodile+AC%2C+et+al.+%E2%80%9CUS+FDA+Breast+Implant+Postapproval+Studies+Long-term+Outcomes+in+99%2C993+Patients.%E2%80%9D+Annals+of+Surgery%3B+2019.+269(1)%3A30%E2%80%9336.
THIS INFORMATION HAS BEEN UPDATED: In October 2021, the FDA issued guidance for people with breast implants Read our latest review on this topic.
An article in the Annals of Surgery, researchers conclude that their work supports an association between silicone breast implants and a range of conditions. This journal article was accompanied by two editorials in which experts voiced their disagreement with the way the analysis was performed and the conclusions of the authors. (2/21/19)
Expert Guidelines
The FDA issued guidelines for use of breast implants:
- Breast implant manufacturers are required to include a label warning and a patient decision checklist with all implants:
- The checklist should include the current incidence rates of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII).
- The checklist should also include specific information regarding ongoing patient registries.
- The FDA has provided breast implant manufacturers specific language for an informational card that should be given to all patients following placement of breast implants. The card should include:
- the serial number, lot number, device style, device size and the unique device identifier (UDI) of the implant.
- weblinks to the most up-to-date access to the patient device checklist, boxed warning and labeling of the specific implant.
- In collaboration with the FDA and breast implant manufacturers, the American Society of Plastic Surgeons and the Plastic Surgery Foundation launched the National Breast Implant Registry (NBIR) in September 2018. The purpose of this database is to collect information from plastic surgeons on breast implant procedures to help improve the quality of care for all patients.
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?
Open Clinical Trials
The following are studies related to breast reconstruction or no reconstruction after mastectomy.
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.