Phone: 01 5553777

Implant Safety Statement

Recent media coverage about medical devices

You may be aware of recent media coverage in relation to medical devices, including breast implants.

I wish to reassure all patients who have undergone implant surgery under my care that FDA-approved devices were used for their surgery. Should you have any concerns, please contact my office on 015553777 or office@fitzgeraldplasticsurgery.ie. My policy for all patients undergoing implant surgery is that I offer free-of charge follow-up appointments for all patients for the entire duration that their implants are in place, and we would be happy to schedule such an appointment for you, including moving forward a scheduled appointment if required.

As discussed prior to your operation, we know of the risk of ALCL, the rare form of blood cancer that can occur in patients with breast implants in place (and textured implants in particular). Depending on the duration since your original operation, there may be more up-to-date information now available in relation to this condition, which I will discuss with you at your scheduled follow-up appointment.

Notwithstanding the content of the statement below, it remains the case that there is no national implant registry in Ireland. As you will be aware, I maintain an anonymised database of all breast implants that I have used over time. We can easily provide you with specific information about your implants, if required.

Should you have any queries or concerns about your implants or the information currently in the media, please do not hesitate to contact us.

Éilís Fitzgerald

27/11/2018

A statement on breast implant safety

From ICOBRA (International Collaboration of Breast Registry Activities) and IAPS (The Irish Association of Plastic Surgeons)

Breast implants are amongst the most used and most highly studied implantable medical devices in the world. Important lessons were learned from historical incidents which have resulted in improvements in the international regulatory system and the widespread introduction of national breast implant registries.

The establishment of effective national breast device registries combined with international collaboration has the ability to significantly improve health outcomes for patients with implantable breast devices globally.

The published literature indicates that breast implants are thought to be safe in general but can have rare, serious side effects.  These side effects have been studied extensively, especially in the field of auto-immune diseases such as Sjogren’s syndrome and rheumatoid arthritis and a rare form of lymphatic cancer, BIA-ALCL.

Plastic and Breast surgeons around the world speak every day with women before and after breast implant surgery for breast reconstruction and augmentation and endeavour to provide patients with well balanced, up to date knowledge to ensure women deciding to undergo this surgery feel confident in their choice.

The important question is, ‘do women with breast implants develop more diseases than women without breast implants?’ The medical literature, to date indicates that the commonest problems associated with breast implants are capsular contracture, implant displacement, and implant rupture.

There is also a rare form of lymphatic cancer, Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). This disease usually presents with rapid enlargement of the breast due to fluid around the implant. It is diagnosed by studying the cells in that fluid and, generally, is eminently treatable by surgery and, where indicated, oncology.

Auto-immune diseases (such Sjögren’s syndrome, chronic fatigue and rheumatoid arthritis) have also been investigated in relation to breast implants. These symptoms have been called ASIA syndrome or breast implant illness (BII).  There is no conclusive evidence of a causal link and more research is needed to assess any potential link between Auto Immune/Inflammatory Syndrome Induced by Adjuvants (ASIA syndrome) and breast implants; one of several names for this potential Breast Implant illness.

More funding is needed to support research into BIA-ALCL and ASIA syndrome. Data collection through effective national breast device registries is an essential part of this research. The Australian Breast device Registry (ABDR) is a model for such national registries.

These registries collect anonymized information about patients with breast implants. The facilitation of international comparison of outcomes from these registries, within the international legal framework of protecting privacy, is enabled through the International Collaboration of Breast Registry Activities (ICOBRA), a collaborative network of national plastic surgery societies, breast surgery societies, regulators and researchers.

Plastic and Breast Surgeons and their associations worldwide will continue to support governments and notified bodies in their regulatory and investigatory work in this field.

Plastic and Breast Surgeons worldwide therefore conclude:

  • Breast implants are safe, but have very rare, sometimes serious, side effects.
  • Women presenting with these side effects should be taken seriously, supported and examined.
  • BIA-ALCL is rare and, usually, eminently treatable
  • Further research is necessary about the role of breast implants and auto-immune diseases and other symptoms (ASIA/BII)

We therefore advise our patients:

  • When you have questions, particularly if you are concerned about symptoms that may be related to your implants, consult your Surgeon.
  • Make sure you are completely informed from reliable sources prior to undergoing breast implant surgery, for any indication.
  • To register your implant and surgery on the national database.