8 Things to Know About Breast Implants

The aesthetic benefit of breast implants may be obvious, but there are lesser known potential risks and reported complications the public should be aware of when considering or living with breast implants. Many people may not experience complications with breast implants, however, the FDA, medical societies, researchers, and patient advocates continue to collaborate for increased safety and better communication. BISA shares current information so you can make informed choices, find support, and learn to advocate for yourself. In 2022, here are eight important things to know about breast implants:

In 2022, here are eight important things to know about breast implants:

1. Breast implants are a Class III medical device, the highest risk class for any medical device. In October of 2021, the FDA issued a boxed warning on all types of breast implants because they carry serious health safety risks.
   

2. Breast Implants can cause systemic symptoms, commonly referred to as Breast Implant Illness (BII). The cause, who will be impacted, and how to treat these health issues are still unknown. Proper removal of the breast implants and scar tissue may contribute to symptom relief. Currently, BII has no diagnostic criteria and is not a recognized official diagnosis.
   

3. The FDA reported in September 2022 that breast implant associated squamous cell carcinoma and other lymphomas found in the scar tissue (capsule) that forms around breast implants. These uncommon cancers can be serious and have been associated with all types of breast implants, including smooth, textured, silicone, and saline. Although reported as rare, the actual testing and reporting have also been rare—meaning the understanding is still emerging. The cause, and who will be impacted, is still unknown.
   

4. Some breast implants have been recalled because they can cause cancer of the immune system (BIA-ALCL). This cancer is currently associated with textured breast implants and expanders, regardless of the manufacturer. However only the Allergan Biocell implants were recalled, and many textured implants still remain on the market.
   

5. All breast implants contain silicone. Saline-filled implants are in a silicone shell. Chemicals in breast implants can leak and bleed microscopically inside the body which may cause health problems. Silicone has also been known to migrate to other parts of the body.
   

6. Some breast implant complications are still not well understood or studied. Screening and additional tests can be costly and may not be covered by insurance. The lack of standards of care can impact people physically, emotionally, and financially.
   

7. Breast implants are marketed to consumers by manufacturers and doctors who make a profit which can contribute to biased information, a lack of informed consent, and additional conflicts of interest.
   

8. Some breast implant safety studies were never completed, breast implants have not been successfully tracked, and some important data was not accessible to the public until recently. Problems with breast implants continue to be underreported because doctors are not required to report them, and the general public is unaware they can self-report to the FDA.

BISA Recommendations

• Research as much as you can when considering breast implants.

• Read the manufacturer safety information in detail before signing any informed consent documents. 

• Keep track of changes in your breast and overall health. Report changes to your doctor.

• Start gathering copies of your medical records.

• Take pictures of your implant identification information and store it in a safe place.

• Report problems, side effects, and any new autoimmune or cancer diagnosis to the FDA Medwatch program. Doctors are not required to do this for you. 

• Sign up for updates from Breast Implant Safety Alliance to stay informed.

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RESOURCES & REFERENCES

FDA: Learn if a Medical Device Has Been Cleared by FDA for Marketing

FDA: Breast Implants

ICIJ: FDA Kept Hundreds of Thousands of Breast Implant Incidents Hidden From Public

Is the FDA Failing Women?

Concerns Regarding Dishonesty in Reporting a Large Study of Patients Treated With Allergan Biocell Breast Implants

What to Know About Breast Implants

Medical Device Reports for Systemic Symptoms in Women with Breast Implants

Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

DrugWatch:  Allergan Breast Implant Recalls

MedWatch: The FDA Safety Information and Adverse Event Reporting Program