At 10 years, approximately 30% of McGhan implants have been changed, for all reasons, according to the FDA. 70%, therefore, have not and, unless there are problems, the advice is to not exchange.
However, complications, such as rupture, may rise over time, through fabric wear and tear. Silent rupture can be picked up on scans, and the cohesive gel is not causing the same problems that pre-1990 “liquid” gels did. BIA-ALCL is being recognised more frequently, and the Australians are forthright in their condemnation of coarse textured implants, such as with McGhan. BIA-ALCL presents as sudden swelling of the breasts, and is probably initiated by an inflammatory separation of the capsule from the implant itself. It is curable by en bloc removal of the implant, provided that no malignant nodules are present, in which case oncotherapy is required. The incidence is probably nearer 1 in 30,000, rather than the inflated Australian suggestion of 1 in 1000 to 1 in 3,000.
The advice is to be aware but, if the implants are not causing problems and you are being screened, then leave alone. The risks of problems from secondary surgery are higher than leaving alone.
Professor J D Frame FRCS FRCS(Plast)
President UK Association of Aesthetic Plastic Surgeons (UKAAPS)
Professor of Aesthetic Plastic Surgery, Anglia Ruskin University, Chelmsford & Cambridge
Consultant Aesthetic Plastic & Reconstructive Surgeon
From: David Ward <firstname.lastname@example.org>
Date: 20 December 2018 at 09:11:02 GMT
To: James D Frame
Subject: BAPRAS Statement: Allergan Textured Breast Implants
The CE certificate for textured breast implants and tissue expanders manufactured by Allergan (Microcell ® and Biocell ®) expired on 16 December 2018.
The MHRA has advised that Allergan has stopped selling these implants and expanders, and intends to withdraw all remaining supply in European markets.
BAPRAS advises that any of these implants manufactured from 17 December 2018 onwards must not be used.
Implants manufactured before 17 December 2018 remain CE marked and therefore could be used. However, before doing so, you should consider if it is wise to use an implant or expander that is no longer being manufactured and is being withdrawn, You must discuss the issue with any patient in whom you are considering using one of these textured expanders or implants, and should give them the choice of using another implant or postponing their surgery.
Smooth implants and expanders manufactured by Allergan still have a CE mark.
The MHRA advises that patients who have already Allergan breast implants or expanders do not need to have them removed or replaced.
BAPRAS continues to work with the MHRA about this issue, and the Association’s advice will be updated if further information becomes available.
Tel: 0207 831 5161