The US FDA has issued a warning over some cancers that have been identified in the scar tissue that develops around breast implants.
- The US FDA has issued a warning about squamous cell carcinoma and different lymphomas developing in the capsule around breast implants
- It is not recommended to remove breast implants. However, it is necessary to monitor the implants and speak with your health care provider if there are any concerns or abnormal changes
Time Between Breast Implants and Cancer Diagnosis
The safety communication also stated that it is still premature to determine the risk factors for squamous cell carcinoma and other types of lymphomas linked to breast implantation. There have been incidents involving people with smooth and textured breast implants and those with saline- or silicone-gel-filled or textured implants. Five patients had squamous cell carcinoma of the breast implant capsule in a 2018 literature study. The median time between breast augmentation and cancer diagnosis was 23 years.Which Cancer is Linked with Breast Implants?
Squamous cell carcinoma can result from chronic inflammation, emphasized Nigel Mercer (UK Medicines and Healthcare products Regulatory Agency, London, UK). Mercer said, “Marjolin ulcers occur around long-standing regions of inflammation and leg ulcers. It is not uncommon to hear of something similar occurring surrounding a breast implant.” He continued, “One would expect other lymphomas occasionally to emerge from an implant. However, BIA-ALCL is the only lymphoma recognized by WHO as cancer related to breast implants.”“With BIA-ALCL, a textured implant is considered causative for the disease. We are unaware of any cases involving purely smooth implants,” commented Mark Clemens (University of Texas MD Anderson Cancer Center, Houston, TX, USA). Identifying the exact mechanism behind cancers related to breast implants is a difficult task. “BIA-ALCL appears to be linked with the allergic pathway going astray. Beyond that, we do not know what causes it. We do not have a good human model to study these implants- you cannot test them for the length of time a human being lives for,” explained Mercer.
BIA-ALCL is a T-cell lymphoma. The focus of the recent FDA notification is B-cell lymphomas linked to breast implants. According to Clemens, “We have seen the Epstein-Barr virus in all the known cases of B-cell lymphomas. Thus, there is a viral mediator contributing to the pathogenesis.”
Statistics of Breast Cancer
1130 cases of BIA-ALCL had been reported globally as of April 1, 2022, including 59 fatalities, according to the FDA. However, considering the gaps in global data, particularly when it comes to statistics on breast implants, these numbers are likely certainly underestimated.From the few published cases, it would be impossible to determine the global prevalence of either squamous cell carcinoma or the numerous lymphomas linked to breast implants. Approximately five million to 35 million women have had breast implants worldwide. Every year, almost 400000 women in the USA undergo breast augmentation surgery alone, either for aesthetic reasons or following a mastectomy.
Squamous cell carcinoma and the different lymphomas of the capsule cannot be detected by mammography, nor are there any screening tests for them. Considering the reported malignancies, the FDA is not advising people with no signs of disease to have their implants removed or to change their regular care and follow-up.
“Taking out a breast implant is a major undertaking,” agreed Mercer. He noted that if the scar tissue is left behind, the risk of BIA-ALCL remains. But removing the capsule is a complex task, especially if it is firmly attached to the ribs. The primary purpose of the FDA communication was to alert patients and caregivers to the existence of the cancers, rather than to recommend any course of action. “It is very important that women who either have implants, or are considering them, have this information, but they should also be aware that these cancers are incredibly rare,” Clemens added.
Source-Medindia