SILICONE BREAST IMPLANTS AND PREGNANCY

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(Date of issue: May 2017, Version: 1.1)

This is a UKTIS monograph for use by health care professionals. For case-specific advice please contact UKTIS on 0344 892 0909. To report an exposure please download and complete a pregnancy reporting form. Please encourage all women to complete an online reporting form.

A corresponding patient information leaflet on silicone breast implants and pregnancy is available at www.medicinesinpregnancy.org.

Summary

Silicone breast implants are used in cosmetic breast augmentation and breast reconstruction.  They consist of an elastomer silicone shell filled with viscous silicone gel.

Silicone implants have a limited lifespan and 4-6% rupture in situ, resulting in leakage of the gel filler.  Silicone gel may also leak from intact implants by diffusion.  Case reports have suggested a link between silicone breast implants and an increased risk of systemic illness, including rheumatological and auto-immune disease, but meta-analysis of the available data does not support an association.

Similarly, case reports and small cohort studies have described infants with immune pathologies born to and/or breastfed by mothers with silicone breast implants.  However, larger studies have generally not provided evidence of increased rates of adverse pregnancy outcomes and childhood illness in offspring of women with breast implants.  Further studies are required to accurately define the risk, if any, to babies born to and/or breastfed by women with silicone implants.

In 2011/2012, it was discovered that silicone breast implants made by the French company Poly Implant Prothèse (PIP) contained industrial silicone rather than medical-grade fillers and have subsequently been shown to be more prone to rupture and leakage than other types of implant.  No data currently exist specifically regarding the safety during pregnancy of PIP implants.

Exposure to silicone breast implants, including PIP implants, at any stage in pregnancy would not usually be regarded as medical grounds for termination of pregnancy or any additional fetal monitoring.  However, other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome.  Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.  Discussion with UKTIS is recommended.     

This document is regularly reviewed and updated. Only use full UKTIS monographs downloaded directly from TOXBASE.org to be sure you are using the most up-to-date version. The summaries of these monographs are openly available on UKTIS.org.

This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to health care professionals at www.toxbase.org.

If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.

If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.

Disclaimer: Every effort has been made to ensure that this monograph was accurate and up-to-date at the time of writing, however it cannot cover every eventuality and the information providers cannot be held responsible for any adverse outcomes of the measures recommended. The final decision regarding which treatment is used for an individual patient remains the clinical responsibility of the prescriber. This material may be freely reproduced for education and not for profit purposes within the UK National Health Service, however no linking to this website or reproduction by or for commercial organisations is permitted without the express written permission of this service. This document is regularly reviewed and updated. Only use UKTIS monographs downloaded directly from TOXBASE.org or UKTIS.org to ensure you are using the most up-to-date version.