January 04, 2018
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Breast implants increase risk for anaplastic large cell lymphoma

Women with breast implants had increased risk for developing breast anaplastic large cell lymphoma, according to results of a population-based study.

The relative risk for anaplastic large cell lymphoma in the breast among women with breast implants reached 421.8 per million, whereas the absolute risk appeared lower at 29 per million at age 50 years and 82 per million at age 70 years.

Increased awareness of the potentially serious complications of breast implants is needed, according to the researchers.

“Our results emphasize the need for increased awareness among the public, medical professionals and regulatory bodies, promotion of alternative cosmetic procedures and alertness to signs and symptoms of breast-anaplastic large cell lymphoma in women with implants,” Mintsje de Boer, MD, PhD candidate from the department of plastic, reconstructive and hand surgery at Maastricht University Medical Center in the Netherlands, and colleagues wrote.

Previous research has shown associations between silicone breast implants and adverse events, including cancer and autoimmune diseases. However, risk for anaplastic large cell lymphoma in the breast in relation to breast implants was largely undiscussed in these studies.

In 2008, researchers first reported an increased risk for this rare lymphoma type based on five cases. By 2015, the number of reported unique cases had increased to 173 and, by February 2017, the FDA had received 359 international medical device reports, which included nine deaths.

To define the absolute and relative risks for breast anaplastic large cell lymphoma, researchers used the Nationwide Network and Registry of Histo- and Cytopathology in the Netherlands to identify 782 women diagnosed with non-Hodgkin lymphoma in the breast between 1990 and 2016.

Among these patients, 47 had primary breast-anaplastic large cell lymphoma. Researchers administered questionnaires to treating physicians of patients with anaplastic large cell lymphoma and 190 controls to confirm whether the breast was the primary site of involvement, results of lymphoma treatment and breast implant history.

Responses confirmed breast as the primary site for 43 patients (median age, 59 years). Final analysis included these patients and 146 controls (median age, 61 years).

Thirty-two patients (median age, 56 years) with anaplastic large cell lymphoma had an ipsilateral breast implant. The other 11 patients with anaplastic large cell lymphoma did not previously receive implants.

Among the controls, one patient had a breast implant for cosmetic indication in the lymphoma-affected breast, and another patient had a breast implant for reconstructive purposes in the contralateral breast, which was not lymphoma affected.

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The OR for breast-anaplastic large cell lymphoma associated with a breast implant was 421.8 (95% CI, 52.6-3,385.2). The OR increased by 10% when adjusted for age and calendar year.

In 2015, the prevalence of breast implants among women aged 20 to 70 years was 3.3%, ranging from 2.3% between age 20 and 30 years, 4% between 31 and 40 years, 4.2% between 41 and 50 years, 3.6% between 51 and 60 years and 2.1% between 61 and 70 years.

Absolute risk for breast-anaplastic large cell lymphoma was one per 35,000 at 50 years; one per 12,000 at 70 years; and one per 7,000 at 75 years.

Cumulative risk for breast-anaplastic large cell lymphoma in the general population increased with age and reached 0.35 per million at 75 years.

A total of 6,920 women with implants were needed to cause one case of breast-anaplastic large cell lymphoma case before age 75 years.

A majority (n = 23) of the implants among patients with anaplastic large cell lymphoma were macrotextured, which was more than expected by researchers. Sales data indicated 49,193 of 109,449 total implants sold between 2010 and 2015 were macrotextured implants (P < .001).

Risk-benefit evaluations on breast implants are regularly needed, and will be the responsibility of regulatory and governmental bodies, according to the researchers.

“Collaboration between international research groups, registries and governmental organizations to pool multidisciplinary data on breast implant-associated anaplastic large cell lymphoma cases and breast implant prevalence are essential to support these efforts,” the researchers wrote.

Steven M. Horwitz

Systematically collected data are essential to continue to evaluate the risks and nature of breast implant anaplastic large cell lymphoma, according to Colleen M. McCarthy, MD, reconstructive surgeon in the department of surgery at Memorial Sloan Kettering Cancer Center, and Steven M. Horwitz, MD, medical oncologist in the department of medicine at Memorial Sloan Kettering Cancer Center.

“The relative scarcity of knowledge and experience with breast-anaplastic large cell lymphoma worldwide creates a unique need for all stakeholders to participate and cooperate,” McCarthy and Horwitz wrote in a related editorial. “It is only with this type of cooperation that questions may turn into answers.” – by Melinda Stevens

Disclosures: The study authors and McCarthy report no relevant financial disclosures. Horwitz reports a consultant role with and research funding from Seattle Genetics.