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Textured Breast Implants Shown to be Riskier than Smooth-Surface Alternatives

Health Canada seems to have made the right move in taking textured implants off the market; smooth-surface alternatives exist.


This article was first published in The Montreal Gazette.


In case you missed it, Health Canada has acted to take a specific type breast implant off the market because of a concern that textured implants might cause a rare form of cancer known as breast-implant associated anaplastic large cell lymphoma (ALCL). Initial reports date back to 2008 when Dutch researchers reported an association between breast implants and ALCL, although this analysis was only based on five cases of the disease. Subsequent research from 2015 documented 79 reported cases and 94 unreported cases in the world literature. As of 2018, the U.S. Food and Drug Administration had received 660 reports of ALCL (457 after duplicate reports were removed). While exact numbers are hard to come by because of limitations on how these cases are documented around the world, suffice it to say that the number of cases seems to be going up.

A recent paper in JAMA Oncology, by the same Dutch researchers who first published in 2008, has provided more supportive evidence. Again using health data from the Netherlands, they compared 43 patients with ALCL to controls with another type of breast lymphoma. In the ALCL patients, 74 per cent of them had breast implants, with the vast majority being textured implants. In the control group, only 0.7 per cent did.

Mathematically this results in a 400-fold increased risk, which sounds astronomically high until you consider that ALCL is a very rare cancer. The authors estimated that the risk of developing this cancer by age 50 was 29 per million, and rose to 82 per million by age 70. To put it in more concrete terms, you get one extra case of ALCL for every 6,920 breast implants.

On the absolute scale, this risk seems very small, but we should remember that breast implants are often implanted electively. In this study about two-thirds of the patients with breast implants and ALCL got their breast implants for cosmetic reasons (not after a mastectomy or breast surgery) and the largest age group was the 20 to 30 year olds. So given that a large number of women get implants for purely elective reasons, even a small cancer risk may not be acceptable.

Furthermore, the risk of ALCL seems to be tied only to textured implants and not those with a smooth surface. Therefore, an alternative still exists when breast implants are either necessary or desirable.

Therefore, the decision to take these implants off the market seems like it should be an easy one. But there is always a risk that preliminary evidence like this will turn out to be wrong. The Dutch paper was a case-control type study, which has a history of overstating risks. A famous 1981 paper using this type of design found a link between coffee and pancreatic cancer that was later refuted. We’ve also been down this road before with silicone breast implants that were taken off the market in 1992 over health concerns, only to be re-instated in 2006. Analyses in 2000 and 2016 failed to show any signal for harm. Finally, no one seems to have come up with a convincing explanation as to how and why textured implants would cause a rare type of lymphoma. There is some suggestion that the textured surface allows the development of a biofilm that is triggering the white blood cells, but this is still speculative.

Despite these caveats, Health Canada was probably right to act as they did, because textured breast implants are not medically necessary and smooth surface alternatives already exist. It is true that the risks, if real, appear to be very small. But if you forgo the implants all together, the risk is zero.


@DrLabos

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