Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery?
Those are common questions people have when considering breast implants.
That’s why the FDA offers the following information to help people make informed decisions about whether or not to use breast implants.
The FDA has approved implants for increasing breast size, for reconstruction after breast cancer surgery or trauma, and to correct developmental defects. The FDA has also approved breast implants to correct or improve the result of a previous surgery.
There are two types of FDA-approved breast implants: saline-filled (saltwater solution) and silicone gel-filled. Both have a silicone outer shell and vary in size, shell thickness, shell surface texture, and shape (contour).
Know the Risks of Breast Implants
FDA-approved implants undergo extensive testing before approval to demonstrate reasonable assurance of safety and effectiveness. Still, there are risks associated with all breast implants, including:
Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), which is a cancer of the immune system
Systemic symptoms, commonly referred to as Breast Implant Illness (BII)
Capsular contracture (scar tissue that squeezes the implant)
Rupture (tears or holes in the shell) of saline and silicone gel-filled implants
Deflation (with visible change to breast size) of saline-filled implants
Silent (without symptoms) rupture of silicone gel-filled implants
The silicone used for breast implants is different than injectable silicone. Injectable silicone is not FDA-approved for breast augmentation, breast reconstruction, or for body contouring.
Breast Implants Are Not Lifetime Devices
The longer you have breast implants, the greater the chances are that you will develop complications, some of which will require more surgery.
The life of breast implants varies by person and cannot be predicted. That means everyone with breast implants may need additional surgeries, but no one can predict when. Patients can also request additional surgeries to modify the size or shape of their breasts.
Understand Product Labeling for Implants
To help patients be aware of the risks of breast implants before their surgery, the FDA requires that all FDA-approved breast implants include labeling with easy-to-understand information about the benefits and risks associated with the product. This requirement is intended to enhance the discussions patients have with their doctor about the benefits and risks of implants. The mandatory labeling information includes a patient decision checklist that highlights key information about risks; warning information formatted in a box to make it noticeable; and a patient device card with information specific to a patient’s implant, such as the serial or lot number and the style and size.
The FDA restricts the sale and distribution of breast implants to only health care providers and facilities that provide information to patients using the patient decision checklist. The patient must be given the opportunity to initial and sign the checklist before agreeing to surgery and it must be signed by the physician implanting the device.
Additionally, the FDA advises that patients read the Summary of Safety and Effectiveness Data and product labeling for each implant to learn about the materials used to construct the device, device characteristics and the fillers used. The Summary of Safety and Effectiveness Data have been produced for all approved saline and silicone gel-filled breast implants. The Summary of Safety and Effectiveness Data and the product labeling provide information on the indications for use, risks, warnings, precautions, and studies associated with the FDA’s approval of the device.
The Summary of Safety and Effectiveness Data also provides information on clinical study used for device approval. The most serious complications are those that lead to further surgeries, such as ruptures or capsular contracture, or BIA-ALCL diagnosis.
Know the Long-Term Risks of Breast Implants
The FDA has identified an association between breast implants and the development of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin’s lymphoma. Patients who have breast implants may have an increased risk of developing this cancer which mostly develops in the fluid or scar tissue surrounding the implant.
Breast implants have either smooth or textured surfaces (shells). BIA-ALCL develops more frequently in patients with textured implants than in those with smooth-surfaced implants. Like other lymphomas, BIA-ALCL is a cancer of the immune system and not of breast tissue.
Some patients with implants have also reported health problems such as connective tissue diseases (such as lupus and rheumatoid arthritis), trouble breastfeeding, or reproductive problems. There is currently insufficient evidence to support an association between breast implants and those diagnoses.
Additionally, some patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and others. Individual patient risk for developing these symptoms has not been well established.