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FDA Confirms Association Between Breast Implants and Lymphoma
Chaffin Luhana LLP
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As of September 30, 2018, the FDA had received 660 medical device reports of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), including nine deaths. Though not a form of breast cancer, BIA-ALCL is a cancer of the immune system that starts in the scar tissue and fluid near the implants and has the potential to spread to other parts of the body.

The FDA warned about a possible association between breast implants and this type of lymphoma back in 2011. Since that time additional reports and scientific studies have provided further evidence of the link between the two. One of the main findings is that the risk of BIA-ALCL seems to be higher in individuals who receive textured breast implants than smooth breast implants.

Studies Confirm Link Between Breast Implants and ALCL

In January 2011, the FDA reported a “possible” association between ALCL and breast implants. The disease itself is extremely rare, but the FDA believed at that time that women with breast implants could have a slightly elevated risk of developing it.

Since then, a number of published studies have confirmed a link between implants and ALCL. In a 2017 analysis, researchers reviewed 80 cases of women who had received breast implants and then developed ALCL. The average age was 52 years, and the average time between implantation and lymphoma was 11 years.

Forty-one percent of the women had silicone breast implants, 42.19 percent were saline, and 15.8 percent were unknown. The coverage was texturized in 21.3 percent, and unknown in 78 percent. Patients who developed LCL received treatment which could include removing the breast implant and prescribing chemotherapy. Three of the women died.

In a 2017 study from Australia, researchers confirmed an association between breast implants and ALCL. They analyzed sales data from three leading breast implant manufacturers dating back to 1999. They found 55 cases of BIA-ALCL diagnosed in Australia and New Zealand between 2007 and 2016. The mean age of the women was 47.1 years and the mean time of implant exposure was 7.46 years.

In this study, all of the women had textured implants. Four of them died. The researchers compared types of implants and found that the risk of developing BIA-ALCL is 14.11 times higher with Biocell textured implants and 10.84 times higher with polyurethane (Silimed) textured implants compared to Siltex textured implants.

Textured Implants More Risky

Textured breast implants have a bumpy, rather than a smooth, surface, which scientists believe may produce chronic irritation that triggers an immune system reaction. Plastic surgeons started using the textured variety initially because they were less likely to slip or move around within the breast pocket. Textured implants were also supposed to reduce the risk of contracture.

As of February 2017, the FDA had received notice of 359 cases of BIA-ALCL associated with patients with breast implants, 203 occurred in women with textured implants, while only 28 occurred in those with smooth implants. Bacteria may also be involved in the development of ALCL, as some studies have found traces of bacterial biofilm on the implants, particularly on the textured ones. These bacteria are associated with an increased immune response that could explain why a patient with textured implants may develop ALCL.

The FDA recommends that healthcare providers give patients with implants routine care and support, and watch for symptoms like fluid collection around the implant, pain, lumps, swelling, and breast asymmetry. Surgeons have also been reminded to go over all the risks with patients before implantation.

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