Implant Safety

The following three extracts outline the position of the British Department of Health and United States Food and Drug Administration (FDA) on silicone gel breast implants. A summary of their findings can be found below:

Silicone Gel Breast Implants – The Report from the Independent Review Group UK  (1998)

The Independent Review Group was established in response to concerns expressed by women in relation to silicone breast implants. It reviewed the evidence relating to the possible health risks associated with silicone gel breast implants. If you are contemplating surgery with breast implants you can obtain this information from the MHRA Website. Its findings were as follows:

  • No evidence of abnormal immune response to silicone from breast implants
  • No evidence for any link between silicone gel breast implants and any established connective tissue disease
  • Good evidence lacking for the existence of atypical connective tissue disease such as silicone poisoning.
  • The overall biological response to silicone is consistent with conventional forms of response to foreign materials

Breast Implants – Information for women considering breast implants (2011)

This is the latest document about breast implants from the UK Dept of Health (Medicines and Healthcare Products regulatory Agency).  This publication is for all women considering having breast implants. It summarises the issues associated with breast implant surgery and provides a detailed list of potential complications that can occur. If you are contemplating surgery with breast implants you can obtain this information from the MHRA Website.

US Food and Drug Administration (FDA) Update on the Safety of Silicone Gel-Filled Breast Implants (2011)

A detailed report by the US FDA assessing safety of silicone gel filled implants. This provides a detailed analysis of the complications associated with silicone gel implant placement. It specifically looks at the safety of Allergan and Mentor implants, the only 2 silicone gel implant makes with a licence for use in the USA until 2012. If you are contemplating surgery with breast implants you can obtain this information from the FDA Website.

Its conclusion was as follows:

Based on the totality of evidence, the FDA believes that silicone gel-filled breast implants have a reasonable assurance of safety and effectiveness when used as labelled. Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make informed decisions about their use. Manufacturers and physicians should continue to provide balanced and up-to-date information to women considering breast implants to help inform their decisions.

For the latest advice on Poly Implant Prothese (PIP) implants, please see the final report from the Expert Review Group by following the links on The Department of Health Website.

If you have any further questions on implant safety, these can be discussed during a consultation.