Breast Implant Safety & FDA Guidance

Age Guidelines

Silicone gel implants are FDA-approved for breast augmentation in patients 22 years and older. Saline implants are approved for augmentation in patients 18 years and older.

Both are approved for breast reconstruction at any age where medically appropriate.

Implants Are Not Lifetime Devices

Breast implants are long-lasting but are not permanent devices. Most patients will require additional surgery at some point.

Common reasons for further surgery include implant rupture, capsular contracture, changes in breast shape or skin elasticity, implant malposition, or simply a wish to change size or type. Long-term follow-up is recommended for every patient with implants.

Screening and Imaging

Silicone implants can rupture without symptoms — a silent rupture. Because of this, the FDA recommends routine imaging even in patients with no concerns.

Current guidance recommends a first ultrasound or MRI at 5–6 years after placement, then every 2–3 years thereafter. Where ultrasound findings are unclear, MRI is recommended.

Patients with saline implants do not require routine imaging surveillance, as rupture is immediately apparent through visible deflation.

BIA-ALCL

Breast implant-associated anaplastic large cell lymphoma is a rare cancer of the immune system — not breast cancer — associated primarily with textured-surface implants. It is treatable, and in most cases cured by removal of the implant and surrounding capsule.

Report any new swelling, fluid collection, or mass developing around an implant, particularly years after surgery.

Breast Implant Illness

Some patients report systemic symptoms — fatigue, joint pain, cognitive difficulty, rash — that they attribute to their implants. This is described as breast implant illness. It is not currently a formally recognized diagnosis, and research is ongoing.

Dr. Low’s position is straightforward: your symptoms are real, and you do not need a formal diagnosis to justify having implants removed. Many patients report improvement following explantation. This will be discussed with you seriously and without dismissal.

Making an Informed Decision

Every implant patient should understand: the type and manufacturer of their implants, the imaging schedule recommended for them, the signs that warrant assessment, and the reality that further surgery is likely at some point. Dr. Low provides implant documentation to every patient — keep it.