Breast implants are medical devices placed under breast tissue or muscle to increase breast size or to replace breast tissue that have been removed from cancer. There are two types of implants approved for used in the U.S.: saline and silicone. Both shells are made up of silicone and can be smooth or textured. Because of the recent link between breast implant-associated anaplastic large cell lymphoma (BIA- ALCL) and textured implants, the FDA has recommended against the use of textured implants.
BIA-ALCL presents as swelling and accumulation of fluids after many years of implant placement. It is associated with textured implants with extremely rare incidence 1 out of 30, 000 patients. It is a type of non-Hodgkin lymphoma but is more local and can be treated successfully with removal of breast implants and scar tissue around it. No chemoradiation is needed.
Breast Implant Illnesses is described as fatigue, memory loss, rash, “brain fog,” and joint pain by some patients with implants. The exact relationship is unclear at this time.
Patient who are considering having breast implants should be aware of these rare potential risks associated with implants. To ensure that patients have all necessary information to make an informed decision about having implants, plastic surgeons should provide patients with a boxed warning, a patient decision checklist, and a patient information booklet/brochure specific to the breast implant prior to implantation. For those patients who decide to have breast implants, a patient device card should also be provided to patients after surgery.
Patients should have their first ultrasound or MRI at 5-6 years after initial implant surgery and then every 2-3 years thereafter. If patients have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.
Boxed warning includes
- Breast implants are not considered lifetime devices
- The chance of developing complications increases over time
- Some complications will require more surgery
- Breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
- BIA-ALCL occurs more commonly in patients with textured breast implants than smooth implants, and deaths have occurred from BIA-ALCL
- Breast implants have been associated with systemic symptoms
Patient Decision Checklist
- Situations in which the device should not be used or implanted
- Considerations for a successful breast implant candidate
- Risks of undergoing breast implant surgery
- Importance of appropriate physician education, training and experience
- Risk of BIA-ALCL
- Risk of systemic symptoms
- Discussion of options other than breast implants, as appropriate
1 For more information, see https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants.
2 For more information and meeting materials, see https://www.fda.gov/advisory-committees/advisory-committee- calendar/march-25-26-2019-general-and-plastic-surgery-devices-panel-medical-devices-advisory-committee.
3 Ibid.
Considering breast implants? Reach out to the doctors at Napa Solano Plastic Surgery and schedule your consult to discuss your options today.