FDA Strengthens Breast Implant Safety Requirements and Updates Study Results
On October 27, 2021, the FDA took several new actions to strengthen breast implant risk communication and help those who are considering breast implants make informed decisions.
First, the FDA issued orders restricting the sale and distribution of breast implants to help ensure that patients considering breast implants are provided with adequate risk information so that they can make fully informed decisions.
Second, the FDA approved new labeling for all legally marketed breast implants that includes:
- Boxed warning.
- Patient decision checklist, which must be reviewed with the prospective patient by the health care provider to help ensure the patient understands the risks, benefits and other information about the breast implant device. The patient must be given the opportunity to initial and sign the patient decision checklist and it must be signed by the physician implanting the device.
- Updated silicone gel-filled breast implant rupture screening recommendations.
- Device description with a list of specific materials in the device.
- Patient device card.
The breast implant manufacturers have posted the updated device labeling to their websites.
Lastly, the FDA released updated information on the status of breast implant manufacturer post-approval studies.
Breast implant surgery can be performed in a hospital or surgery center. Breast implant surgery patients may have to stay overnight in the hospital (inpatient surgery) or may be able to go home afterward (outpatient surgery). The surgery can be done under local anesthesia, where the patient remains awake and only the breast is numbed to block the pain, or under general anesthesia, where medicine is given to make the patient sleep. Most women receive general anesthesia for this surgery. Breast implant surgery can last from one to several hours depending on the procedure and personal circumstances.
If the surgery is done in a hospital, the length of the hospital stay will vary based on the type of surgery, any complications after surgery, and your general health. The length of the hospital stay may also depend on the type of coverage your insurance provides.
On this page:
- Surgical Mesh and Breast Surgery
- Surgical Consultation
- Questions to Ask Your Doctor Before Having Breast Implant Surgery
- Related Links
Surgical mesh is typically a flexible, thin flat sheet, usually made of nondegradable synthetic materials, biodegradable synthetic materials, or from animal- or human-derived tissues called acellular dermal matrices (ADM). Surgical mesh is a medical device, regulated by the FDA.
The FDA has not cleared or approved any surgical mesh for use with breast implants or in breast reconstruction, and thus has not reviewed potential benefits and risks for these uses. The FDA recommends that patients discuss the benefits and risks of mesh with their health care providers.
Before surgery you should have a consultation with your surgeon. Be prepared to ask questions about the surgeon's experience, your surgery and expected outcomes. The FDA has provided a list of questions that may help guide your discussion. The surgeon should be able to discuss whether you are a good candidate for breast implants, the different type of implants, options for size, shape, surface texture, and placement based on your particular circumstances, as well as the risks and benefits of implant surgery. The surgeon should also be able to provide you with before and after pictures of other patients to help you better understand your expectations and potential outcomes from surgery.
During the consultation you will need to discuss your medical history, including any medical conditions or drug allergies you may have. You should also discuss any previous surgeries you've had, especially to the breast, and what drugs you are currently taking, including supplements, herbal and over-the-counter (OTC) medications. It is important to tell the surgeon if you think you may be pregnant.
If you are undergoing breast implant surgery for reconstruction, you will also need to speak with your surgeon about your personal circumstances, including being treated with chemotherapy and/or radiation therapy, as these can affect your risks of complication and the appearance of the reconstructed breast. The surgeon should also speak to you about the amount of breast tissue that will remain after surgery and future screening for breast implant ruptures and breast cancer.
During the consultation, be sure to ask the surgeon for a copy of the patient labeling for the breast implant she or he plans to use. This should include a patient booklet/brochure that includes important information about your specific breast implant, as well as a boxed warning and patient decision checklist. You have the right to request this information, and your physician is expected to provide it.
Be sure to read the patient labeling entirely prior to surgery. Please know that this patient labeling is intended to enhance, but not replace, the discussion you have with your physician about the benefits and risks of breast implants as they uniquely pertain to you.
After reviewing the information in the patient booklet/brochure for the specific implant that will be used, please read and discuss the items in the checklist carefully in consultation with your physician. You should place your initials in the location provided next to each item to indicate that you have read and understood the item and that your physician has answered all questions to your satisfaction. In addition, please make sure you read and understand the informed consent form before you sign it. If you decide to proceed with the surgery, your physician should also provide you with a patient device card after your surgery that has information on each of your specific implants.
Breast implant manufacturers may be conducting clinical studies to evaluate breast implants and to understand the long term experiences of women who receive breast implants. If you are interested in participating in a clinical study, be sure to ask your surgeon what specific steps you will need to take.
When choosing a surgeon for a breast implant procedure, you may want to consider their years of experience, their board certification, their patient follow-up, and your own comfort level with the surgeon. Most breast implant procedures are performed by board-certified plastic and reconstructive surgeons. The following questions can help guide your discussion with your surgeon regarding breast implant surgery.
Questions to Ask...
About Your Surgeon
- How many breast implant procedures do you do each year?
- What percentage of your practice is dedicated to breast augmentation? To breast reconstruction?
- What type of implants do you use? Saline or silicone? What is your experience with each?
- What is the most common complication you encounter with breast implant surgery?
- What is your rate of complications in general (capsule contracture, infection, etc.)?
- What is your reoperation rate?
- What is the most common type of reoperation you perform?
About Breast Implants and Expected Outcomes
- What shape, size, and surface texture are you recommending for my implants?
- Why are you recommending one type of breast implant over another? Why do you recommend this one for me?
- How long will my breast implants last?
- What incision site and placement are you recommending for me?
- Do you have before and after photos I can look at for each procedure?
- What results are reasonable for me to expect?
- How will breast implants feel? Will they alter my breast skin or nipple sensation?
- What are the risks and complications associated with having breast implants?
- Can I still get breast implants for augmentation if I have a strong family history of breast cancer?
- How many additional operations on my breast implants can I expect to have over my lifetime?
- How will I be able to tell if my breast implant has ruptured or if there is a problem with my breast implants?
- How will my breasts look if I decide to have the implants removed and not replaced?
- How easy or difficult is it to remove the implants?
- How easy or difficult is it to increase the size of the implants after the breast implants have been placed?
- What can I expect my breasts to look like over time? What do I need to do to maintain them?
- What kind of additional follow-up will I need?
- What are the long-term consequences of breast implants?
- What will my breasts look like after pregnancy? After breastfeeding?
- Will the breast implants affect my ability to breastfeed a baby?
- What are my options if I am dissatisfied with the outcome of my breast implants?
- Can I still get mammograms with breast implants in place?
- Will the mammogram rupture my breast implant?
- What alternate procedures or products are available besides breast implants?
About the Breast Implant Operation
- How long will I be in pain after the surgery?
- What is my expected recovery time?
- Will I need help at home for normal activities after the surgery and if so for about how long?
- How long do you expect my operation to take?
- What (if any) secondary procedures associated with my breast augmentation/breast reconstruction will be required?
- How likely is it that I will get an infection after the surgery?
- How much risk is there from the anesthesia?
- What can I do to minimize the risk of short-term and long-term complications?
- Where will my scar be?
- UPDATE: Reports of Squamous Cell Carcinoma (SCC) in the Capsule Around Breast Implants - FDA Safety Communication (3/8/2023)
- FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
- The FDA Requests Allergan Voluntarily Recall Natrelle BIOCELL Textured Breast Implants and Tissue Expanders from the Market to Protect Patients: FDA Safety Communication
- Statement from FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health on FDA's new efforts to protect women's health and help to ensure the safety of breast implants
- Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety Communication (3/31/21)
- National Library of Medicine – Breast Augmentation Series
- National Library of Medicine – Breast Reconstruction – Implants
- National Library of Medicine – Breast Augmentation Surgery
- American Society of Plastic Surgeons (ASPS) – Breast Augmentation
- American Society of Aesthetic Plastic Surgeons (ASAPS) – Breast Augmentation Surgery