Maria Caulfield, Member of Parliament for Lewes and Minister for Women’s Health, recently released an update to all Members of Parliament on progress to increase transparency of the risks associated with breast implants, in light of substandard Poly Implant Prothèse (PIP) breast implants.
The Department for Health and Social Care reviewed information available to patients about breast implants and augmentation surgery including information relating to Breast Implant Associated Anaplastic Large Cell Lymphoma.
A large amount of information is available online, however the government is going further than this and will strengthen the transparency and accessibility of information for patients. The provision of essential information in both a digital and written format could improve patients’ understanding of potential risks. The Minister therefore requested that the Medicines and Healthcare products Regulatory Agency (MHRA) amend their guidance pages on Breast Implant Associated Anaplastic Large Cell Lymphoma, which was completed in April 2023.
The amendment recommends that prospective patients are given information relating to the risks posed by breast implants by their surgeon in writing prior to the patient providing informed consent for the surgery. Alternatively, patients are provided with a link to the Tri-Association Breast Augmentation Information sheets from the Association of Breast Surgery.
In addition, as part of the MHRA’s update to the medical device regulations to improve patient safety, the MHRA intends to introduce a requirement for clinicians to provide patients with an implant card and information regarding any warnings, precautions, or measures to be taken by the patient or healthcare professional. This will strengthen transparency and support patients in understanding their implants. The MHRA anticipate that this requirement will take effect in 2025.
Commenting, Maria Caulfield MP said:
“It is extremely important that women are made aware of the risks with breast implants, including the risk of non-Hodgkin’s lymphoma growing in response to the implant. I hope that these changes will go some way to ensuring women can make an informed decision”