What to know about breast implants

U.S. Food and Drug Administration (FDA)

Should I get breast implants? Should they be saline or silicone? Which style? How much monitoring is needed after surgery? These are common questions people have when considering breast implants.

The FDA has approved implants for increasing breast size (known as augmentation), 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:
• Additional surgeries.
• 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).
• Breast pain.
• 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.
• Infection.

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.

Communicate with Your Surgeon

Surgeons will discuss the shape, size, surface texture, placement of the implant, and the incision site for each person. Ask your surgeon questions about their experience in performing breast implant surgeries, the surgical procedure, and the ways the implant might affect your life.

Tell your surgeon about previous surgeries and your body’s response. For example, discuss whether surgeries resulted in a more than expected amount of scar tissue. Also, discuss your expectations. These discussions will help you and the surgeon make decisions that achieve the desired appearance, including decisions about incision location and size, as well as implant size, material, texture, and placement.

Many patients have additional operations to change implant size. To achieve the best results after the first procedure, careful planning and reasonable expectations are necessary.

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.

Monitor Your Breast Implants

In general, follow your surgeon’s instructions on how to monitor your breast implants.

If you notice any unusual signs or symptoms, report them promptly to your surgeon or health care provider. Health care providers and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

Also, follow your health care provider’s instructions for imaging for screening for breast cancer as this may be different for those patients who had breast augmentation and for those patients who had breasts reconstruction. If you are making an appointment for mammography, inform the mammography facility that you have breast implants, and ask them what you can expect regarding mammography with breast implants.

Your surgeon or health care provider may also recommend other tests, such as ultrasound or magnetic resonance imaging (MRI). The FDA recommends that patients with silicone implants get regular screenings to detect silent ruptures.

If you have specific questions about breast implants, ask your surgeon or health care provider.