Breast cancer implant study suggests links with illness but has serious flaws

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.

• NCT04533373: Sensory Restoration After DIEP Flap Neurotization. The goal of this study is to look at how well a nerve graft works for improving sensation to the reconstructed breast after mastectomy in people undergoing DIEP flap reconstruction. 
• NCT04491591: Implementing BREASTChoice Into Practice. Breast reconstruction after mastectomy is a highly personal decision. A clinical decision support tool, BREASTChoice, with personalized risk information and patient preferences, was created to be used to address these issues. This study will evaluate whether BREASTChoice assists reconstruction decisions.
• NCT04293146: Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC. This study will compare the effect of under-the-muscle versus over-the-muscle reconstruction on quality-of-life outcomes. 

• NCT05020574: Microbiome and Association With Implant Infections. The 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.