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UPDATE: In March 2023, the FDA issued a safety notice with updated information about squamous cell carcinoma (SCC) in the scar tissue (capsule) surrounding breast implants. The March 2023 announcement updates the September 2022 safety announcement that informed the public about reports of cancers, including SCC and various lymphomas, in the capsule. The various lymphomas are not the same as the lymphomas previously described by the FDA as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA believes that cases of SCC and lymphomas in the capsule may be rare. The FDA recommends that healthcare providers talk to people who have or are considering breast implants about SCC and various lymphomas in the capsule around breast implants. The FDA continues to ask health care providers and people with breast implants to report cases of any cancer surrounding breast implants to the FDA.
Should I get breast implants? Should it be saline or silicone? Which style? How much follow-up is needed after surgery?
These 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 to increase breast size (known as augmentation), to reconstruct 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: filled with saline (seawater solution) and filled with silicone. 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 efficacy. However, 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 disease (BII)
- Capsular contracture (scar tissue pressing on the implant)
- Chest pain
- Rupture (tears or holes in the shell) of saline and silicone gel implants
- Swelling (with a visible change in breast size) of saline-filled implants
- Silent (asymptomatic) rupture of silicone gel-filled implants
- Contamination
The silicone used for breast implants is different from injectable silicone. Injectable silicone is not FDA approved for breast augmentation, breast reconstruction, or body contouring.
Breast implants are not lifelong devices
The longer you have breast implants, the greater your chances of developing complications, some of which will require more surgery.
The lifespan of breast implants varies from person to person and cannot be predicted. This means that everyone with breast implants may need additional surgeries, but no one can predict when. Patients may also request additional surgeries to modify the size or shape of their breasts.
Understand product labeling for implants
To help patients know the risks of breast implants before surgery, the FDA requires that all FDA-approved breast implants include labeling with easily understood information about the benefits and risks associated with the product. This requirement is intended to enhance the discussions patients have with their doctors about the benefits and risks of implants. Mandatory labeling information includes a patient decision checklist that highlights key information about risks. warning information boxed for visibility; and a patient device card with information specific to a patient’s implant, such as serial or lot number and 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 must be signed by the physician implanting the device.
In addition, the FDA advises patients to read the Summary of Safety and Efficacy Data and the product label for each implant to learn about the materials used to make the device, the device’s characteristics, and the filling materials used. Summary of Safety and Efficacy Data have been created for all approved saline and silicone gel breast implants. The Summary of Safety and Efficacy Data and product labeling provide information about the indications for use, risks, warnings, precautions, and studies relevant to FDA approval of the device.
The Summary of Safety and Efficacy Data also provides information about the clinical study used to approve the device. The most serious complications are those that lead to further surgery, such as capsular tears or contracture or a diagnosis of BIA-ALCL.
Contact your surgeon
Surgeons will discuss the shape, size, surface texture, implant placement, and incision site for each individual. Ask your surgeon about their experience performing breast implant surgery, the surgical procedure, and the ways the implant can affect your life.
Tell your surgeon about previous surgeries and your body’s response. For example, discuss whether the surgeries resulted in a larger 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 the location and size of the incision, as well as the size, material, texture, and placement of the implant.
Many patients undergo additional surgery to resize the implant. To achieve the best results after the first procedure, careful planning and reasonable expectations are required.
Know the long-term risks of breast implants
The FDA has identified an association between breast implants and the development of 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 mainly 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 surface implants. Like other lymphomas, BIA-ALCL is a cancer of the immune system, not of the breast tissue.
Some implant patients have also reported health problems such as connective tissue diseases (such as lupus and rheumatoid arthritis), breastfeeding problems, or reproductive problems. Currently, there is insufficient evidence to support an association between breast implants and these diagnoses.
In addition, some patients receiving breast implants have reported a variety of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, autoimmune diseases, and more. The risk of individual patients 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 to your surgeon or health care provider immediately. Healthcare providers and patients are encouraged to report adverse events or side effects associated with the use of these products to the FDA’s MedWatch Adverse Event and Safety Information Reporting Program.
Also, follow your healthcare provider’s instructions for imaging to screen for breast cancer, as this may differ for those patients who had breast augmentation and those patients who underwent breast reconstruction. If you make an appointment for a mammogram, tell the mammogram that you have breast implants and ask them what you can expect about the mammogram with breast implants.
Your surgeon or health care provider may also recommend other tests, such as an ultrasound or magnetic resonance imaging (MRI). The FDA recommends that patients with silicone implants have regular examinations to detect silent ruptures.
If you have specific questions about breast implants, ask your surgeon or health care provider.
