Quick answer: The FDA says two types of breast implants are approved for sale in the United States: saline-filled and silicone gel-filled. Both have a silicone outer shell. They differ most in what happens if they rupture and in how you’d find out. Whichever you consider, your provider must review an FDA patient decision checklist with you, and the labeling includes a patient device card.
Saline or silicone is usually the first question at a breast augmentation consultation. Dr. Soltero’s practice works with both. Here’s what the FDA’s own pages say, so you can have that conversation with a little more background.
What’s the same about saline and silicone?
Both are medical devices that the FDA says are implanted under the breast tissue or chest muscle to increase breast size, or used in reconstruction or revision surgery. Both have a silicone outer shell. Both vary in size, shell thickness, shell surface texture and shape.
Both also come with the same headline from the FDA: they’re not lifetime devices. Complications and additional surgery are possible with either. Read why breast implants aren’t lifetime devices for what that can mean.
What’s different?
| Saline-filled | Silicone gel-filled | |
|---|---|---|
| Filled with | Saltwater (saline) solution | Silicone gel |
| If it ruptures | The saline leaks and the implant deflates, immediately or over several days | The gel usually stays within the scar tissue around the implant, though it can travel further |
| Would you notice? | The FDA says you’ll notice a change in size or shape | Often not. Most ruptures have no symptoms |
| Rupture screening | Ask your surgeon | Your provider may recommend regular MRI or ultrasound, which may not be covered by insurance |
The FDA has received reports of systemic symptoms from some patients with both types. It says it hasn’t detected an association between silicone gel-filled implants and connective tissue disease, breast cancer or reproductive problems, but that larger and longer studies would be needed to fully understand these complications.
Does texture matter?
Ask about it. The FDA says there are different shapes, styles and textures of implants and asks you to discuss your goals and the benefits and risks with your surgeon. It also says BIA-ALCL, a type of lymphoma that can develop following breast implants, appears more often in patients with textured breast implants. In 2019, the FDA requested a recall of certain textured implants and tissue expanders from one manufacturer.
Does the size you pick matter later?
It can. The FDA’s list of complications includes dissatisfaction with style or size, where the patient or doctor isn’t satisfied with the overall look based on the implant used. It also says women with large implants, especially those placed on top of the chest muscles, may have major cosmetic deformity if they choose not to replace them after removal. So size isn’t only a question of how you want to look now. Ask how your choice could affect your options later.
What about breastfeeding?
The FDA says some women who undergo breast augmentation can successfully breastfeed and some cannot. It also says it isn’t known whether a small amount of silicone may pass from the implant shell into breast milk, and that there are no established methods for accurately detecting silicone levels in breast milk. If you plan to breastfeed, bring it up early.
What is the patient decision checklist?
It’s part of the labeling the FDA approved on October 27, 2021, for all legally marketed breast implants. The FDA describes it this way:
- It must be reviewed with you by the health care provider.
- It’s meant to help ensure you understand the risks, benefits and other information about the device.
- You must be given the opportunity to initial and sign it.
- The physician implanting the device must sign it.
The checklist exists so that the risk conversation happens, and that you have a record of it. You can ask to see it early rather than on the day of surgery, so you have time to read it and come back with questions.
What is the patient device card?
The new labeling also lists a patient device card, along with a device description with a list of specific materials in the device. Ask your surgeon what your card shows, and keep it with your medical records. It’s worth having on hand if you see a different provider years from now, or if a question about your specific device comes up.
The FDA also encourages patients to report problems through MedWatch, its safety reporting program.
Where do manufacturers’ labels come in?
The FDA says the breast implant manufacturers have posted updated device labeling on their websites, and it tells you to read the patient labeling and other educational materials carefully, then discuss any questions with your surgeon before deciding. Ask which manufacturer and device your surgeon is considering, so you’re reading the right document.
What should you ask about saline or silicone?
- Which type would you consider for me, and why?
- What size, shape, texture and placement would you consider?
- If I choose silicone, what screening do you recommend, and how often?
- Which device are you considering, and may I read its patient labeling?
- May I see the decision checklist before the day of surgery?
- Will I get a device card, and when?
Where to go from here
Before you decide on a surgeon, you can check their California license and read the FDA’s list of things to weigh before choosing breast implants. Dr. Soltero is certified by the American Board of Plastic Surgery; you can read more about him or book a consultation in English or Spanish.
