Patient Safety Advisory – Breast Implant Removal and Capsulectomy

Patients with breast implats may choose to have them removed at some point. Whether undertaken for medical reasons or personal choice, breast implant removal requires careful planning, skilled surgical execution, and thorough postoperative care to prevent further complications and ensure patient well-being.

Why are people making this decision?

Patients with breast implants may experience health issues. This condition is commonly referred to as Silicone Incompatibility Syndrome (SIS), Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA), and Breast Implant Illness (BII). The US Food and Drug Administration (FDA) now requires all implant packages to include a warning about the possibility of systemic symptoms such as joint pain, muscle aches, confusion, chronic fatigue, and autoimmune diseases.

Patients may request that both the implant and the surrounding capsule to be removed together, which is known as “en bloc” removal. This is because toxins from the implant, like heavy metals, silicone, bacteria, or fungus, could be present in the capsule.

What we know for certain

  • Patients have reported symptoms they associate with breast implants regardless of the type of implant (saline or gel-filled, smooth or textured), and the symptoms have been reported with implants from all manufacturers.
  • Over 100 different symptoms have been reported, and there is no specific pattern.
  • Some patients experience an improvement in their symptoms after implant removal.

Terminology is Important

There has been a joint statement from various organisations in the field of aesthetic plastic surgery regarding breast implant removal and capsulectomy. The statement emphasises the importance of using evidence-based medicine and not making unsupported claims. The use of the term “en bloc” is appropriate for the removal of a tumor along with surrounding tissue, but it should not be used to describe routine capsulectomy. Additionally, the term “Breast Implant Illness” suggests a direct causation that has not been definitively proven, so a more precise term would be “Systemic Symptoms Associated with Breast Implants (SSBI).”

The statement also mentions a study funded by the Aesthetic Surgery Education and Research Foundation (ASERF) that compared women with self-described BII to control groups. The study found that the BII group had more symptoms at the beginning, experienced rapid symptom improvement after implant removal, and there were no significant differences in biospecimens between the groups.

Moving Forward with Breast Implant Removal

Plastic surgeons are advised to keep up with scientific knowledge, avoid making unsupported claims about en bloc capsulectomy, and not promote themselves as “explant experts” without sufficient training or evidence. Patients should undergo a medical evaluation to rule out other potential causes of their symptoms before considering implant removal. They should be informed about the risks and benefits of different removal options, as partial capsulectomy or no capsulectomy may also lead to symptom improvement. Ongoing research is needed, and recommendations may change as more data becomes available.

As always, Dr Turner would like to remind all patients, whether they have visited our clinic or not, to always seek advice from a board-certified Specialist Plastic Surgeon before making a decision about Breast Implant Removal and Capsulectomy. Patients are reminded that breast implants are not lifelong devices and require regular check-ups with their surgeon. The integrity of the implants should be evaluated periodically, and persistent symptoms should be evaluated for other medical conditions before considering implant removal surgery.