FDA asks Allergan to recall certain textured breast implants

https://www.facingourrisk.org/XRAY/FDA-recall-Allergen-BIOCELL-textured-breast-implants

Full article: https://www.fda.gov/medical-devices/safety-communications/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

On July 25, 2019, the Food and Drug Administration requested that breast implant manufacturer Allergan recall its BIOCELL textured implants and expanders due to an association with a rare type of lymphoma called Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL. The FDA does not recommend removing implants for people who do not have disease symptoms. This XRAYS review updates information about this FDA recall. (7/29/19)

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.

NCCN has outlined principles of breast reconstruction or going flat following mastectomy surgery. These include the following:

All patients undergoing breast cancer treatment should be educated about breast reconstructive options based on their situation.
Selection of reconstruction option is bassed on many factors, including cancer treatment, patient preference, obesity, smoking history, comorbidities and patient concerns.
Patients may chose not to have breast reconstruction after mastectomy. The option of mastectomy with no reconstruction and optimized closure (aesthetic flat closure) should be part of the discussion of patients' options after mastectomy.
Breast reconstruction or going flat should be a shared decision between the patient and their surgeon.

Questions To Ask Your Health Care Provider

What are the pros and cons of breast implants?
What are the pros and cons of textured and smooth breast implants?
What are the BIA-ALCL symptoms that I should be aware of after I get breast implants?
I had surgery years ago. How can I find out what type of implants I have?
I have BIOCELL implants, what are the pros and cons of having them removed?
I have BIOCELL implants and want to have them removed, will my insurance pay for it?
What breast reconstruction options do not involve implants?
What factors should I consider when deciding between different breast reconstruction options?
What type of follow up should I have after mastectomy and reconstruction? Should I have breast MRI? If so, how frequently? Will my insurance pay for these follow-ups?

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.

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.