Free Breast Augmentation Consent Form Template

Informed Consent for Breast Augmentation with Implants

Patient Informed Consent Documentation

Patient and Surgical Information

Nature and Purpose of the Procedure

Breast augmentation is a surgical procedure performed under general anesthesia or intravenous sedation to increase breast volume, improve breast shape and symmetry, or restore breast volume lost following pregnancy, breastfeeding, or weight loss. The surgeon makes an incision at the chosen site (inframammary fold, periareolar border, or transaxillary approach) and creates a tissue pocket either in the submuscular plane (beneath the pectoralis major muscle), the subglandular plane (between the breast gland and chest muscle), or a combination dual-plane. A silicone gel or saline-filled implant of the planned size is inserted into the pocket and centered behind the nipple-areola complex. The incision is closed in layers with absorbable sutures. The procedure typically takes 1 to 2 hours and is performed as a day-surgery case. It is important to understand that breast implants are not lifetime devices and future surgical procedures will very likely be required over the patient's lifetime.

FDA Warning: Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

The U.S. Food and Drug Administration (FDA) has confirmed an association between breast implants, particularly textured-surface implants, and a rare type of T-cell lymphoma called Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIA-ALCL is not breast cancer; it develops in the fluid and scar capsule surrounding the implant, most commonly presenting as delayed peri-implant seroma (fluid accumulation) or a palpable mass years after implantation. The estimated lifetime risk ranges from approximately 1 in 2,207 to 1 in 86,029 depending on implant type and texture. When detected early and treated by complete capsulectomy with implant removal, BIA-ALCL is usually curable. Patients should report any new persistent swelling, pain, or mass around a breast implant promptly. Macro-textured and certain microtextured implants carry the highest documented risk; smooth-surface implants have a substantially lower but non-zero documented risk.

FDA Recommended Screening Schedule (Silicone Gel Implants)

The FDA recommends that patients with silicone gel-filled breast implants undergo their first breast MRI 5 to 6 years after implantation to screen for silent (asymptomatic) implant rupture, and then every 2 to 3 years thereafter. MRI is the most sensitive imaging modality for detecting intracapsular silicone gel rupture, which may not be detected by physical examination or ultrasound alone.

Material Risks and Potential Complications

Alternatives to Implant-Based Augmentation

Expected Benefits

The intended benefit of breast augmentation is an increase in breast volume and enhancement of breast shape and symmetry consistent with the surgical plan. Most patients report improved body image and self-confidence following the procedure. In reconstructive contexts (post-mastectomy, developmental hypoplasia), the procedure aims to restore anatomical form and symmetry. The procedure does not correct ptosis (sagging) without an accompanying breast lift.

Preoperative and Postoperative Photography Consent

Standard clinical photography will be taken before and after your procedure for medical record documentation. These photographs are protected health information and will not be shared publicly without your separate written authorization. A separate media release form is required if you consent to use of your photographs for educational or publication purposes.

Smoking Cessation and Health Optimization Requirement

Smoking and nicotine use substantially increase the risk of wound healing complications, implant infection, and capsular contracture. You are required to cease all smoking, vaping, and nicotine product use for a minimum of 6 weeks before and 6 weeks after surgery. Failure to comply may result in procedure cancellation and forfeiture of surgical fees. You must also disclose all medications, supplements, and herbal products, as certain agents (e.g., aspirin, fish oil, vitamin E, St. John's Wort) increase bleeding risk and must be stopped as instructed.

Right to Refuse or Withdraw Consent

You have the right to refuse this procedure or withdraw your consent at any time before the procedure begins without penalty or adverse effect on your medical care.

Questions and Understanding Confirmation

I confirm that I have received and reviewed the FDA Patient Decision Checklist for breast implants. I understand that breast implants are not lifetime devices, that future surgery will likely be required, and that I have been informed of BIA-ALCL and the MRI surveillance schedule for silicone gel implants. All my questions have been answered to my satisfaction. I am at least 18 years of age (or 22 years for silicone gel implants per FDA guidance). I believe I am making an informed and voluntary decision.

Language Access and Interpreter Services

If English is not your primary language or if you require assistance communicating, a qualified interpreter is available at no cost. Please notify your care team before signing this document.

Copy of Consent Acknowledgment

I acknowledge that I have been offered a signed copy of this informed consent form and the FDA Patient Decision Checklist for my own records.

Patient Authorization

I confirm that I am at least 18 years of age (or 22 years for silicone gel implants per FDA guidance). I have reviewed the FDA patient labeling for breast implants provided to me. I understand that breast implants are not lifetime devices and that I will likely require additional surgery in the future. I have been informed of BIA-ALCL and the recommended MRI surveillance schedule. I consent to proceed with breast augmentation with the implant specifications documented above.

Signatures and Verification