Q: Back in 2018 my then surgeon put in an implant I did not agree to that has been banned, and was banned before I had it placed, and as a result, is causing constant fear and anxiety, does the surgery have a duty of care to correct this with a different surgeon? I was not made aware of the type of implant, I did not agree to it. The surgeon chose the implant type and size. I hate the fact this Implant is in me and I hate the size. I always have and I always will. What are my options now?
September 2, 2024
Answer: Previously banned implants thanks for this interesting question. I am sorry to hear that this has happened and I understand the distress this might be causing you. I believe there are 3 different brands of implants that have been officially withdrawn from use in UK in relatively recent times for reasons of safety concerns about manufacture / design. this means that the MHRA (uk's healthcare medicines and devices regulator) removes its approval (CE certificate). 2010 - 'PIP' implants 2015 (25th September) - silimed implants 2018 (16th December) - allergan textured implants I agree that in UK, an implant shouldn't be used after the date which MHRA has withdrawn certificate and it would be reasonable to seek to have this remedied if your facts are correct. In terms of having the implant removed or exchanged you would need to bring this to the attention of the clinic / surgeon who treated you previously if you want them to remedy the situation by, for example, reoperating or by refunding. These withdrawals are difficult because they cause a lot of anxiety. The reality is that there are risks with all types of implants and those that have been withdrawn are simply considered to be rather less safe than the ones that haven't when statistics and data are analysed and therefore they have been withdrawn....but this doesn't mean that a bad or dangerous outcome awaits everybody who has one of the banned implants......far from it...the vast majority will still expect to have no problems. The advice about all of these implants, so far as I am aware, is that the risk of problems remains low and the odds are strongly in favour of there being no adverse health effects from these implants on a case-by-case basis - so it is not thought to be obligatory to remove/replace unless there are signs or symptoms (e.g swelling, tightening, firmness, pain), not least because there can be some risks from exchanging implants..... and all types of implants (not just the banned ones) have the potential to need removal (capsule formation, change of breast shape with time, pain, rupture). If your breasts feel soft and you are happy with appearance my advice is to accept this but, if you become aware of any symptoms or changes you should seek early advice and often NHS breast clinic will be the best and quickest access for assessment and likely a scan. best wishes Oliver Harley Plastic Surgeon
Helpful
September 2, 2024
Answer: Previously banned implants thanks for this interesting question. I am sorry to hear that this has happened and I understand the distress this might be causing you. I believe there are 3 different brands of implants that have been officially withdrawn from use in UK in relatively recent times for reasons of safety concerns about manufacture / design. this means that the MHRA (uk's healthcare medicines and devices regulator) removes its approval (CE certificate). 2010 - 'PIP' implants 2015 (25th September) - silimed implants 2018 (16th December) - allergan textured implants I agree that in UK, an implant shouldn't be used after the date which MHRA has withdrawn certificate and it would be reasonable to seek to have this remedied if your facts are correct. In terms of having the implant removed or exchanged you would need to bring this to the attention of the clinic / surgeon who treated you previously if you want them to remedy the situation by, for example, reoperating or by refunding. These withdrawals are difficult because they cause a lot of anxiety. The reality is that there are risks with all types of implants and those that have been withdrawn are simply considered to be rather less safe than the ones that haven't when statistics and data are analysed and therefore they have been withdrawn....but this doesn't mean that a bad or dangerous outcome awaits everybody who has one of the banned implants......far from it...the vast majority will still expect to have no problems. The advice about all of these implants, so far as I am aware, is that the risk of problems remains low and the odds are strongly in favour of there being no adverse health effects from these implants on a case-by-case basis - so it is not thought to be obligatory to remove/replace unless there are signs or symptoms (e.g swelling, tightening, firmness, pain), not least because there can be some risks from exchanging implants..... and all types of implants (not just the banned ones) have the potential to need removal (capsule formation, change of breast shape with time, pain, rupture). If your breasts feel soft and you are happy with appearance my advice is to accept this but, if you become aware of any symptoms or changes you should seek early advice and often NHS breast clinic will be the best and quickest access for assessment and likely a scan. best wishes Oliver Harley Plastic Surgeon
Helpful