The TGA has no plans to ban or restrict textured breast implants despite increasing evidence linking them to anaplastic large cell lymphoma (BIA-ALCL).
In a recent update the regulator said it had begun a scientific review of the surface topography of breast implants marketed in Australia after receiving 78 confirmed reports of BIA-ALCL in Australian patients, including four deaths.
The regulator said its laboratories would analyse more than 150 breast implant samples and match the findings with known cases of BIA-ALCL “to better estimate the risks associated for each type of implant”.
However the TGA will not yet decided to follow the lead of regulatory authorities in in France and Canada, where selected textured implants have been taken off market after reports showed this type of implant was associated with ALCL.
“Based on the outcomes of the testing and statistical analysis, we anticipate that a decision on whether regulatory action will be undertaken relating to specific implants will be made in mid-June,” the TGA said.
It is thought the textured surface of implants could encourage the growth of a bacterial biofilm, which in turn stimulates T-cells that promote lymphoma. The TGA has previously said the evidence suggests the risk of BIA-ALCL might be reduced by using smooth rather than textured implants.
The regulator noted the ALCL was rare given that there are more than 15,000 procedures a year and textured implants are used in more than 80% of reconstructive implants.
“Smooth implants are an alternative but they may require a higher rate of replacement reoperation due to greater rates of contracture of these implant,” it said.
Current advice to minimise the risk of ALCL includes stringent infection control measures including antibiotic prophylaxis, pocket irrigation, and avoiding the use of drainage tubes as potential entry sites for bacteria. Screening or prophylactic removal of implants in asymptomatic patients is not recommended.
Meanwhile, a review of the epidemiology of BIA-ALCL in Australia and New Zealand conducted by surgeons and haematologists has confirmed that the highest risk is with [textured] Grade 4 Surface Breast Implants.
The review, co-authored by haematologist Professor Miles Prince, notes that the majority of cases have been detected early-stage (1A, effusion-limited) disease, which is indolent and curable through surgery alone.
“The importance of early detection and treatment cannot be more strongly emphasised. Three of the four patients that presented with advanced disease experienced a delay in diagnosis, which may have contributed to the risk of spread,” it states.
The authors of the Australian Joint BIA-ALCL Task Force review suggest that routine surveillance programs of all women with breast implants should also be considered.
“The risk for grade 3 and 4 surface implants needs to be clearly articulated. It is no longer valid to quote overall risk for all breast implants,” they write in Plastic and Reconstructive Surgery.
‘[Our] data show that BIA-ALCL is essentially a disease associated with grade 3 and 4 breast implant surfaces. The higher level of risk for these implants has also been independently confirmed by other series.