Dutch Study Links Implants to Increased Breast-ALCL Risk

Breast implants are associated with an increased risk — albeit small — of anaplastic large-cell lymphoma (ALCL) in the breast, according to Dutch researchers.

The results of the study, led by Mintsje de Boer, MD, of Maastricht University Medical Centre in the Netherlands, were published in JAMA Oncology.

 The study was prompted, the team explained, by the fact that the number of women with breast implants who have been diagnosed with breast-ALCL since 2008 has increased, with several reports suggesting a link between breast implants and breast-ALCL.

The researchers, therefore, performed a case-controlled study to determine the relative and absolute risks of breast-ALCL in women with implants.

Using the population-based nationwide Dutch pathology registry, de Boer and colleagues were able to identify patients diagnosed with primary non-Hodgkin lymphoma in the breast between 1990 and 2016 and then retrieved their clinical data, including breast implant status.

Among the 43 patients with breast-ALCL (median age of 59), 32 had an ipsilateral breast implant (median age of 56) compared with only one patient among 146 women with other primary breast lymphomas, resulting in an OR of 421.8 (95% CI, 52.6-3385.2) for breast-ALCL associated with a breast implant.

The investigators also examined the connection between specific types of implants and breast-ALCL. Of the 28 patients with breast-ALCL with a known implant type, 23 (82%) had macrotextured implants, which was more than expected considering that less than half (45%) of implants sold in the Netherlands between 2010 and 2015 were macrotextured.

 When looking at the absolute risk for breast-ALCL associated with breast implants, the researchers determined that the estimated prevalence of 20- to 70-year-old women with a breast implant in 2015 was 3.3%, ranging from 2.3% for those ages 20 to 30, 4.0% for those ages 31 to 40, 4.2% for those 41 to 50, 3.6% for those 51 to 60, and 2.1% for those 61 to 70.

The cumulative risk of breast-ALCL in the general population increased with age, reaching about 0.35 per million at the age of 75. For women with implants, the cumulative risk increased from about 29 per million at age 50 to about 82 per million at age 70. De Boer and colleagues calculated that the number of women with implants needed to cause one breast-ALCL case before the age of 75 was 6,920.

“Our relative risk estimate of over 400, implying an attributable risk approaching 100%, is highly suggestive of a direct or indirect causal role of the breast implant-associated ALCL,” de Boer and colleagues wrote.

They also pointed out that their calculations concerning the absolute risk of breast-ALCL has multiple implications considering the relatively large number of women (3.3%) in the Netherlands having implants. These include the need for comprehensive counseling of women considering having breast implants for cosmetic or reconstructive surgery, alternative cosmetic/reconstruction procedures, and the establishment of a registry program for breast implants and their complications.

As for the study limitations, de Boer et al noted that retrospective data on the prevalence of breast implants were not available because of an absence of breast implant registration — which only began in the Netherlands in 2016 — and the lack of reliable and complete historical implant sales data.

“Therefore our absolute risks of breast-ALCL in implant carriers were based on extrapolated data. Even in this nationwide study, numbers were too small to allow definite conclusions on modifying factors, such as duration of implant exposure and implant types.”

In an accompanying commentary, Colleen M. McCarthy, MD, and Steven M. Horwitz, MD, both of Memorial Sloan Kettering Cancer Center in New York City, wrote that while de Boer and colleagues should be commended for their “rigorous approach” to defining the risk of breast-ALCL in patients with implants, the conclusions appear to “more confirmatory than new.”

For example, as noted in this article in MedPage Today, the FDA earlier this year affirmed a link between ALCL and breast implants, and suggested that women with implants should be regularly monitored for signs and symptoms of the disease.

De Boer et al “conclude that breast implants are associated with a strongly increased relative risk of breast-ALCL, yet the absolute risk of the disease presented here remains extremely low,” McCarthy and Horwitz wrote, pointing out that most women with implants newly diagnosed with ALCL are successfully treated with implant removal and capsulectomy alone.

“For a woman and her physician considering options for implant-based surgeries, differences in underlying beliefs and values among women will sway decision making in different directions. Thus, when considering options where there is uncertainty, it is particularly important that the process of decision-making be shared, because these decisions are highly dependent on individual patient preferences and assessment of risk.”

FDA Update on Rare Breast Implant-Associated Type of Lymphoma

The US Food and Drug Administration (FDA) has provided an update on breast implant–associated anaplastic large cell lymphoma.

In January 2011, the agency identified a possible associationbetween breast implants and the development of anaplastic large cell lymphoma (ALCL).

 Since then, “we have strengthened our understanding of this condition and concur with the World Health Organization designation of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as a rare T-cell lymphoma that can develop following breast implants,” the FDA said in a statement March 21.

Over 350 Cases, 9 Deaths

The FDA notes that most data suggest that BIA-ALCL occurs more often after implantation of breast implants with textured surfaces rather than those with smooth surfaces.

As of February 1, 2017, the FDA has received a total of 359 medical device reports (MDRs) of BIA-ALCL, including 9 deaths. Of the 231 reports that included information on the implant surface, 203 concerned textured implants and 28, smooth implants.

Of the 312 reports that included information on implant fill types, 186 described implants filled with silicone gel and 126, implants filled with saline.

“It is important to note that details on breast implant surface and fill type are limited. While the MDR system is a valuable source of information, it may contain incomplete, inaccurate, untimely, unverified, or biased data,” the FDA says.

 During the last 6 years, a “significant body” of literature has been published on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of the disease, the agency notes.  “All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants.”

Most cases of BIA-ALCL are treated by removal of the implant and the capsule surrounding the implant, and some cases have been treated by chemotherapy and radiation. However, because BIA-ALCL has “generally only been identified in patients with late onset of symptoms such as pain, lumps, swelling, or asymmetry, prophylactic breast implant removal in patients without symptoms or other abnormality is not recommended,” the FDA said.

The exact number of cases of BIA-ALCL worldwide is unknown.

The FDA is continuing to collect and evaluate information about BIA-ALCL. For now, the agency recommends that clinicians who have patients with breast implants take the following action:

  • Be aware that most confirmed cases of BIA-ALCL have occurred in women with textured breast implants. Provide the manufacturer’s labeling as well as any other educational materials to your patients before surgery and discuss with them the benefits and risks of the different types of implants.
  • Consider the possibility of BIA-ALCL in a patient with late-onset, persistent peri-implant seroma. In some cases, patients presented with capsular contracture or masses adjacent to the breast implant. A patient with suspected BIA-ALCL should be referred to an appropriate specialist for evaluation. When testing for BIA-ALCL, collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytologic evaluation of seroma fluid with Wright-Giemsa–stained smears and cell block immunohistochemistry testing for cluster of differentiation and anaplastic lymphoma kinase markers.
  • Develop an individualized treatment plan in coordination with the patient’s multidisciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation  or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
  • Report all confirmed cases of ALCL in women with breast implants to the FDA’s MedWatch system.


Deaths From Rare Cancer Linked to Breast Implants

CNN reports that nine deaths have been attributed to breast implants. In each case, a rare form of breast cancer, anaplastic large cell lymphoma (ALCL) was responsible. The FDA responded that this cluster was no cause for alarm as breast implants are linked to only a slightly increased risk of cancer.

Breast cancer is one of the most feared diagnoses a woman can receive. One in 8 women will develop invasive breast cancer in her lifetime. Genetics play a role in breast cancer but there are steps you can take to reduce your risk.

In the largest review of research into lifestyle and breast cancer, the American Institute of Cancer Research estimated that about 40 percent of U.S. breast cancer cases could be prevented by lifestyle choices. I believe this number understates the positive impact of lifestyle modifications.

One of the easiest to implement changes is to improve your diet. Refrain from consuming sugar, especially fructose, and consume only nourishing and whole foods. Processed foods are to be avoided and I recommend limiting protein intake and increasing healthy fat consumption. Obviously, you will want to optimize your gut flora and make sure GMO foods don’t sneak their way onto your menu.

Iodine may also be a crucial player in cancer prevention. Iodine is an essential trace element required for the synthesis of hormones, and the lack of it can also cause or contribute to the development of a number of health problems, including breast cancer. There is evidence that mega doses of iodine are counterproductive.

No matter what health challenges you face, I always recommend optimizing your vitamin D levels. There are hundreds of studies showing the importance of vitamin D. According to Carole Baggerly, founder of GrassrootsHealth, as much as 90 percent of ordinary breast cancer may in fact be related to vitamin D deficiency.