Quick answer: The FDA says breast implants are not lifetime devices. How long they last varies by person and can’t be predicted, and the longer you have them, the more likely you are to have complications or to need them removed or replaced. Plan for monitoring as long as you have them, and for the possibility of one or more additional surgeries.
This is one of the most useful things to understand before breast augmentation, and one of the easiest to skip past. Here’s what the FDA says it means in practice.
What does “not a lifetime device” mean?
It means you shouldn’t think of implant surgery as a one-time event. The FDA says to assume you’ll need additional surgeries, because implants aren’t lifetime devices and complications can occur. There’s no fixed expiry date. The FDA says the life of breast implants varies by person and can’t be predicted.
So the useful question isn’t “when will I need to replace them?” It’s “what would I do if I needed to, and am I comfortable with that?”
What could lead to another surgery?
The FDA lists local complications that occur in at least 1 percent of breast implant patients at any time. Some can be treated without surgery, and some need another operation. Among them:
- Capsular contracture. The scar tissue around an implant tightens and can squeeze it, which can be painful. The FDA says grades III and IV are considered severe and may require reoperation, and that it could occur again after surgery to correct it.
- Rupture or deflation. A tear or hole in the outer shell. Possible causes on the FDA’s list include capsular contracture, compression during a mammogram, trauma and normal aging of the implant.
- Malposition. The implant isn’t in the correct position, or it moves from where it was placed.
- Asymmetry, wrinkling or visibility. Changes you can see or feel.
- Dissatisfaction with style or size. The FDA lists this too. Patient or doctor isn’t satisfied with the overall look.
The FDA also cautions that a reoperation may not give you the cosmetic outcome you hoped for. You may need more than one over your lifetime.
How do saline and silicone ruptures differ?
They behave differently, which is why follow-up differs too.
| Saline-filled | Silicone gel-filled | |
|---|---|---|
| What happens | The saline leaks into your body immediately or over several days, and the implant deflates | The gel usually stays inside the scar tissue around the implant, but it can move beyond it |
| Would you notice? | Yes. The FDA says you’ll notice a change in size or shape | Often not. Most silicone ruptures have no symptoms and are called silent ruptures |
| How it’s found | You and your doctor can tell | MRI is the most effective method. Ultrasound is an acceptable alternative for screening if you have no symptoms |
For more on choosing between the two, see saline or silicone.
What does follow-up look like?
The FDA says implants need to be monitored for as long as you have them. For silicone gel-filled implants, your provider may recommend regular MRI or ultrasound exams to screen for rupture and other complications. Those exams may not be covered by your insurance.
Keep your patient device card and records, and see your surgeon or provider promptly if you notice abnormal changes in your breasts or implants. The FDA says persistent swelling or pain or other changes in the area around the implant should prompt a conversation about further evaluation for BIA-ALCL.
Do implants affect mammograms?
Tell the facility you have implants before any mammogram. The FDA lists compression during a mammogram among the possible causes of rupture. It also says calcium deposits, hard lumps under the skin around an implant, can be mistaken for cancer during mammography and lead to additional surgery.
What are the options when implants come out?
The FDA describes two main approaches, and says to discuss with your surgeon which is right for your situation.
- Removing the implant alone. The scar capsule around it stays in your body. This requires less surgical dissection and may carry less risk of local complications such as bleeding.
- Removing the implant and part or all of the capsule. This can be more extensive and is sometimes called en-bloc resection, or total or partial capsulectomy. The FDA says patients with confirmed BIA-ALCL should generally have the implant and surrounding capsule removed.
After removal, you can replace the implants or not. If you don’t, the FDA says you may have changes to your natural breasts such as dimpling, puckering, wrinkling or breast tissue loss. See breast lift, reduction and implant removal if that’s the conversation you need to have.
What should you budget for?
Two things the FDA says plainly: the cost of removal or replacement may not be covered by insurance even if you have complications, and screening MRI or ultrasound exams may not be covered either. Prices aren’t listed on this site, so ask about them at your consultation. Include future costs in your thinking, not only the first surgery.
What should you ask your surgeon?
- What follow-up do you recommend, and how often?
- What would you do if I developed capsular contracture?
- If I need a reoperation, what’s the process, and what would it cost?
- What would removal look like, and what would my breasts look like after it?
- Who do I call if something changes years from now?
If you’ve read this far, the FDA’s list of things to weigh before choosing breast implants is a good next stop. When you’re ready, you can read about Dr. Soltero or book a consultation, in English or Spanish.
