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What to consider before undergoing reconstructive surgery

Breast reconstruction can be a physically and emotionally rewarding option for a woman who has lost a breast due to cancer or another disease. Through a variety of plastic surgery techniques, the shape, appearance, and size of the breast may be restored. However, a reconstructed breast will never look or feel exactly the same as the breast that was removed.

Breast reconstruction typically involves several procedures performed in separate surgical interventions. It can begin at the same time as the mastectomy, or it may be delayed until a patient has healed from her mastectomy and recovered from any additional cancer treatments. It is important that a woman feel ready for the emotional adjustment involved. Much like losing a breast, it takes some time for a woman to accept the results of a new reconstructed breast. Visible incision lines will always be present either from the reconstruction or the mastectomy.

When only one breast is affected, it alone may be reconstructed. In addition, a breast lift, reduction, or augmentation may be recommended for the opposite breast to improve symmetry for the size and position of both breasts. Some women may choose to remove the other, unaffected breast prophylactically. Insurance companies are now required by law to provide coverage for breast reconstruction and related procedures to adjust the opposite breast. Precertification may be required, depending on a patient’s insurance carrier.

Some women choose not to undergo a surgical reconstruction. There are a variety of breast prostheses available to fit into your bra or a special bra to help you feel your best.

New guidelines from the FDA

We want to keep you informed of new regulations regarding breast implants. On Oct. 27, 2021, the US Food and Drug Administration (FDA) added several new safety requirements for the use of breast implants. These guidelines are intended to help make sure that you receive and understand the benefits and risks of breast implants so that you can make informed decisions about breast reconstruction surgery options.

The new actions put into place by the FDA include:

Labeling breast implants with a “boxed warning” label

Similar to warnings on some medications, the information in the breast implant boxed warning states that:

  • Breast implants are not considered to be lifetime devices. They may need to be replaced at some point in the future.
  • The chance of developing complications increases over time.
  • Some complications will require more surgery.
  • Breast implants have been associated with the development of a cancer of the immune system called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This cancer occurs more commonly with textured breast implants than smooth implants.
  • Patients with breast implants may experience systemic symptoms such as joint pain, muscle aches, confusion, fatigue and autoimmune diseases.

Providing a Patient Decision Checklist

The FDA now requires that implant manufacturers sell breast implants only to healthcare providers who thoroughly review the risks of breast implant surgery using a Patient Decision Checklist. The checklist helps organize the key information the surgeon will discuss with you before surgery to help you decide whether to undergo the procedure.

As part of this process, you and your plastic surgeon are required to sign the checklist in several places before you can schedule implant reconstruction surgery. A copy of the signed checklist will be placed in your chart. It will also be given to you for your records.

Information covered in the checklist includes:

  • Considerations for a successful breast implant candidate
  • Risks of undergoing breast implant surgery
  • Importance of physician education, training and experience
  • Risk of BIA-ALCL
  • Risk of other systemic symptoms associated with breast implants
  • Discussion of options other than breast implant surgery, as appropriate

Other required information

The FDA guidance also recommends that all patients receive the following information:

  • Screening recommendations for detecting a rupture in silicone gel-filled breast implants
  • Device material/manufacturing descriptions, including chemicals that may be released by breast implants
  • A patient device card

What is the risk of developing cancer from a breast implant?

There are two types of implants:

  • Ones with a smooth shell
  • Ones with a textured shell

The risk of developing Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL is associated more often with textured breast implants. However, patients with smooth breast implants have also been diagnosed with BIA-ALCL.

Estimates for the risks of developing BIA-ALCL in patients with textured implants ranges from 1 in 3,000 patients to 1 in 30,000. For patients who have textured implants, there is currently no evidence to suggest that removing the implants eliminates the risk of BIA-ALCL. The FDA, American Society of Plastic Surgeons, and the American College of Surgeons do not recommend removing textured breast implants to prevent BIA-ALCL. However, if a patient has symptoms of BIA-ALCL, treatment involves removal of the implant and the capsule surrounding the implant. Some patients have also required chemotherapy and/or radiation therapy.

Where do I begin?

A consultation with a plastic surgeon is the first step in learning how breast reconstruction can restore your appearance. This will include a discussion of your goals and expectations. Evaluation of your anatomy and personal medical details will determine your options for treatment. The expected outcomes of breast reconstruction and any potential risks or complications will be reviewed. The success of your procedure, its safety, and your overall satisfaction requires full disclosure of your health history, including medications, your use of vitamins, herbal supplements, alcohol, tobacco, and drugs. The plastic surgeon will answer your questions, and together you will develop a treatment plan.

To read more about what things to consider before getting a breast implant, please visit the FDA website for additional information.