What You Need to Know About the New FDA Breast Implant Guidelines

What you Need to Know About the New FDA Breast Implant Guidelines and Checklist

On October 27th, 2021, the FDA announced new breast implant safety guidelines for both manufacturers and surgeons. These guidelines are intended to enhance patient safety, increase transparency around the potential risks and side effects of breast implants, and ensure patients provide informed consent before receiving implants. With concerns over breast implant illness and other possible implant-related risks on the rise, these guidelines have largely been met with support from both patients and surgeons, including surgeons from the American Board of Cosmetic Surgery.

As an organization dedicated to enhancing patient safety, we wrote this post to help you make sense of these guidelines and understand potential risks associated with breast implants.

What do the new FDA breast implant guidelines include?

The FDA is now requiring that the following guidelines be included in all breast implant labeling, which all surgeons are expected to review with their patients:

  • A boxed warning. All breast implant packaging must feature a boxed warning alerting patients to any potentially significant health risks.
  • Patient decision checklist. Surgeons are now required to provide their patients with a decision checklist brochure, which includes many of the potential risks, side effects, and benefits associated with breast implants. The checklist also lists alternatives to implant-based breast augmentation, such as fat transfer breast augmentation and breast lift without augmentation.Each implant manufacturer will need to modify the checklist to reflect the unique risks and nuances specific to the types of implants they offer. (For example, manufacturers of textured implants will have to disclose that this type of implant has been associated with a higher risk of BIA-ALCL.)

Additionally, the checklist emphasizes the importance of choosing a physician with the appropriate education, training, and experience to perform breast augmentation surgery.

Patients and surgeons must initial and sign this checklist to indicate they have read and understood its content.

  • Routine screening recommendations. The FDA updated their screening recommendations for patients with breast implants. They now suggest that patients undergo rupture screenings 5-6 years after their implant surgery and every 2 years after that. ABCS surgeons tend to agree that the best screening method for implant rupture is with an MRI, as this provides more in-depth imaging of the breast and breast implant.Note that the risk for implant rupture is now as low as 1-2% per year, given the advances in silicone implant technology over the last decade. Thanks to their improved cohesiveness, in the event of a rupture, a silicone implant’s filling material may bulge out of its shell but will remain contained within the breast capsule.
  • List of materials used in implants. For the first time, the FDA is requiring manufacturers to disclose the specific materials used in breast implants. Patients and surgeons will have access to this information.
  • Ongoing research. ​​The FDA also increased the number of ongoing studies regarding breast implant risks and side effects that manufacturers must conduct. According to the organization, previous studies have made “inadequate progress.”

ABCS surgeons are in favor of the FDA’s efforts to ensure patients have the information they need to make informed decisions regarding implant-based breast augmentation.

Breast implant manufacturers have until the end of November 2021 to comply with these new requirements.

What are the risks of breast implants?

The FDA’s patient decision checklist lists the following as potential risks of implant-based breast augmentation:

  • Capsular contracture. This is when the capsule of scar tissue surrounding an implant thickens abnormally and constricts one or both breast implants. Capsular contracture is usually not dangerous, but it can be uncomfortable. Capsular contracture typically is caused by infection, implant rupture, hematoma, or seroma, and is most likely to occur in the first two years after breast augmentation with implants.
  • Implant rupture. Although implant ruptures are very rare, they can occur for a variety of reasons. If an implant does rupture, it is typically due to normal aging of the implant, excessive force being applied to the implant, or puncture from a needle insertion during a biopsy. Unlike saline implants, which noticeably deflate if the shell ruptures, silicone gel implants will maintain their shape, and there is rarely any sign that the rupture has occurred (this is called “silent rupture”)—which is why routine screenings are so important. Even if there are no complications present, a ruptured implant should be removed promptly once it is detected.
  • Implant rippling. Implant rippling is when the edges of an implant become visible through one’s breast skin. It is most common with underfilled saline implants, which are filled during surgery. Though not a dangerous condition, implant rippling creates an undesirable aesthetic outcome for breast augmentation patients.
  • Loss of nipple sensation. Though it is uncommon for women to completely lose sensation in their nipples after breast augmentation with implants, they sometimes experience reduced nipple sensitivity. This is thought to be due to a restriction in blood flow to nerves caused by the breast skin being stretched too tightly over the implant. Choosing implants that are smaller in diameter may help reduce the risk of changes in nipple sensation.
  • Breast implant illness: Breast implant illness (BII) is a term used to describe a variety of immune-related side effects, ranging from cognitive issues to chronic fatigue to joint pain, that may be linked to breast implants. Though BII is not an official medical diagnosis and scientists do not yet have enough data to identify a clear connection between breast implants and the reported symptoms, some women have reported a reduction in symptoms after having their breast implants removed.
  • BIA-ALCL: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an extremely rare form of lymphoma that can be triggered by certain textured breast implants. BIA-ALCL is not a form of breast cancer, and there have only been 733 cases since 2020, according to the FDA. While the medical community is still studying what causes BIA-ALCL and how to prevent it, it is commonly agreed that textured implants may increase one’s risk for developing the condition.

While the medical community is still studying BIA-ALCL, it is commonly agreed that textured implants may increase its risk.

Who should avoid breast augmentation with implants?

According to the FDA’s new guidelines, certain medical conditions should preclude women from getting implants, including breast cancer (treated or untreated) and active infections. Women who are pregnant or nursing should also avoid receiving implants.

Women who may be at risk for a less-than-desirable augmentation result include those with diabetes or lupus, as well as smokers and former smokers, as these conditions all impair the body’s ability to heal itself properly.

How can you help ensure your safety when receiving breast implants?

  • Insist on a board certified cosmetic surgeon. According to the FDA’s new Patient Decision Checklist, implant-based breast augmentation should only be performed by physicians who are appropriately trained and credentialed. One of the best ways to identify a highly qualified cosmetic surgeon is to choose a surgeon who is certified by the American Board of Cosmetic Surgery (ABCS). ABCS surgeons are experts in breast augmentation surgery and will help you understand all of the potential risks, side effects, and benefits of breast implants. A board certified cosmetic surgeon will discuss the various shapes, sizes, and textures associated with different implants, as well as your implant placement and incision options.
  • Schedule regular screenings: While your surgeon will give you specific instructions on how to monitor your breast implants, it’s important to receive regular screenings for breast implant rupture. An ABCS surgeon will discuss your various screening options with you and make recommendations for screening appointments based on your implant type and placement.
  • Replace implants after 10-20 years. Breast implants are not manufactured as lifetime devices. Instead, they should be replaced at the end of their lifespan or if a complication, such as a rupture or capsular contracture, is expected. Most saline and silicone breast implants are FDA-approved for 10-20 years; however, the longevity of your implants may be affected by a variety of factors, such as your implant type, texture, size, placement, as well as your body type and lifestyle.
  • Consider choosing a saline implant. If you are exceptionally concerned about the potential risks associated with breast implants, choosing saline implants, which are filled with a sterile saltwater solution, may be the best option for you. While many patients don’t think saline implants feel as natural as silicone gel implants, they cannot silently rupture and, in the event of a rupture, their filling poses less of a health risk.

Breast implants are not manufactured as lifetime devices and should be replaced at the end of their lifespan or if a complication is expected.

The ABCS supports the FDA’s breast implant guidelines

The ABCS and its surgeons are in favor of the FDA’s efforts to ensure patients have the information they need to make informed decisions regarding implant-based breast augmentation. To learn more about the risks and benefits associated with breast implants, or to explore implant alternatives, use our Find a Surgeon tool to schedule a consultation with a board certified cosmetic surgeon in your area.