Quick answer: Before choosing breast implants, the FDA wants you to know that they are not lifetime devices, that you should assume you will need more surgery at some point, that the cost of removal or replacement may not be covered by insurance, and that implants need to be monitored for as long as you have them. Read the manufacturer’s patient labeling and bring your questions to your consultation.
Most people start by thinking about size and shape. Those matter, and they’re worth talking through with your surgeon. But the decision is also a long-term one, and the FDA publishes a clear list of what to consider. This article walks through it, so you can walk into a breast augmentation consultation with better questions.
Why does the FDA single out breast implants?
On October 27, 2021, the FDA restricted the sale and distribution of breast implants to health care providers and facilities that give patients information about the risks and benefits before use. It also approved new labeling for all legally marketed breast implants. That labeling includes a boxed warning, a patient decision checklist, updated rupture screening recommendations for silicone gel-filled implants, a device description with a list of materials and a patient device card.
We cover the checklist and the device card in saline or silicone, and the FDA’s checklist and device card.
What should you assume about future surgery?
The FDA’s wording is direct: breast implants are not lifetime devices. The longer you have them, the more likely it is that you’ll have them removed or replaced, and the more likely you are to experience complications. It tells you to assume you will need additional surgeries, which are called reoperations.
That doesn’t mean a date is set in advance. The FDA says the life of breast implants varies by person and can’t be predicted. It does mean you should budget time, money and energy for the possibility. Read more in why breast implants aren’t lifetime devices.
What are the most common complications?
The FDA names capsular contracture, reoperation and implant removal as the most common local complications and adverse outcomes. It also lists rupture or deflation, wrinkling, asymmetry, scarring, pain and infection at the incision site. A fuller list is in the manufacturer’s patient labeling, which you can ask your surgeon for.
| What the FDA asks you to consider | What to ask at your consultation |
|---|---|
| Implants are not lifetime devices | What should I plan for if I need another surgery? |
| Removal or replacement may not be covered by insurance | What might that cost, and who could I check with? |
| The most common local complications are capsular contracture, reoperation and implant removal | How would you handle each one if it happened to me? |
| Implants need monitoring for as long as you have them | What follow-up and screening would you recommend? |
| Removing implants without replacing them can change how your natural breasts look | What would I look like if I chose removal later? Is that something I can see examples of? |
What about BIA-ALCL and breast implant illness?
These two are worth reading about directly on the FDA’s pages, because the details matter.
- BIA-ALCL. The FDA says there is a risk of a type of cancer called breast implant-associated anaplastic large cell lymphoma in the breast or the scar tissue around the implant. It is not breast cancer. Treatment involves removing the implant and the capsule around it, and some patients have also needed chemotherapy or radiation. The FDA says that although it’s treatable, there is a risk of death for patients diagnosed with it.
- Breast implant illness. Some patients report symptoms such as chronic fatigue, brain fog and joint and muscle pain, which they call breast implant illness. The FDA says these symptoms may not meet the diagnostic criteria for a disease, that they are poorly understood and that researchers are investigating them. In some cases, patients report that removing the implants without replacing them appears to reverse their symptoms.
If you already have implants and notice abnormal changes in your breasts or implants, the FDA says to see your surgeon or health care provider promptly.
What does long-term monitoring mean?
The FDA says breast implants need to be monitored for as long as you have them. If you have silicone gel-filled implants, your provider may recommend regular MRI or ultrasound exams to screen for rupture and other complications, and those exams may not be covered by your insurance.
It helps to ask this one before you decide, because it’s a cost and a habit that lasts for years, and it can differ by implant type.
What about insurance?
Breast augmentation is an elective procedure, so plan on checking your own coverage rather than assuming. The FDA warns that even if you have complications, the cost of removal or replacement may not be covered. It also says some insurers don’t cover implant removal or replacement even if the first implant surgery was covered. Ask your insurer directly, and ask for the answer in writing if you can.
What should you do before your consultation?
- Read the FDA’s things to consider page.
- Ask for the manufacturer’s patient labeling and read it carefully.
- Check your surgeon’s California license.
- Write down your goals and your questions, and bring them with you.
- Ask to see the gallery. This site doesn’t show patient photos, but Dr. Soltero shows pre- and post-operative pictures at your consultation.
What if you decide not to go ahead?
That’s a fine outcome for a consultation. The point of the conversation is an informed decision, and your decision can be no, or not yet. Here’s how one patient described it in a Google review: “From the initial consultation I felt super comfortable and not pressured to do anything I didn’t want to do.” Individual experiences vary.
To talk it through in English or Spanish, read more about Dr. Soltero or book a consultation.
