In the UK, breast implants are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) rather than the US Food and Drug Administration (FDA).
However, there is still a great deal of confusion around whether or not breast implants in the UK need to be FDA approved.
The FDA is a US government agency that is responsible for protecting public health by regulating medical devices, including breast implants.
The MHRA, on the other hand, is the UK’s regulatory body for medical devices and is responsible for ensuring that all medical devices, including breast implants, meet certain safety and quality standards before they can be marketed and sold in the UK.
While the MHRA does not require breast implants to be FDA approved, it does require them to meet the same safety and quality standards as medical devices that are approved by the FDA. This means that breast implants sold in the UK must be tested for safety and effectiveness, and must meet strict manufacturing and labelling requirements.
However, there are a wider range of implants available in the UK compared with the US and not all of the implants that we use in the UK have been approved by the FDA.
It is important to note that there have been concerns in the past about the safety of certain types of breast implants, including those filled with silicone gel. In 2019, the FDA issued a recall of certain textured breast implants due to their link to a rare form of cancer called breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). While this recall did not affect all breast implants, it highlights the importance of ensuring that all medical devices, including breast implants, are rigorously tested and regulated for safety.
In conclusion, breast implants in the UK do not need to be FDA approved, but they must meet the same safety and quality standards as medical devices that are approved by the FDA.