Updated August 25th, 2020

FDA Reports an Increase in Breast Implant-Related Cancer Diagnoses & Deaths Since Last Year

The Food and Drug Administration (FDA) released a statement in response to reports of a small increase in cancer diagnoses and deaths associated with breast implants. It's important you know the risk.

SurvivorNet Staff

Details

Increase In Breast Implant-Related Cancer Diagnoses

In a report, the Food and Drug Administration (FDA) shared that there’s been 160 new cases of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and three more deaths, since July 2019.
In 2019, textured implants were banned worldwide due to their association with BIA-ALCL
Researchers are continuing to gather data, and urge doctors to inform people of the health risks associated with breast implants

For years, breast implants have been under fire for allegedly being linked to cancer causing some of them to be recalled. In a statement, the Food and Drug Administration (FDA) announced that there’s been a small increase in cancer diagnoses, and deaths, associated with the products.

According to the FDA, there have been 733 reports of women being diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) and breast implant illness (BII) over 2019 and 2020 combined. Among these cases, 620 were linked to Allergan implants and the rest are unknown. So far, 36 deaths have occurred, which represents three more deaths and 160 new cases since last year.

"The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks,” Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, says in the FDA’S press release.

What is BIA-ALCL?

BIA-ALCL is a type of Non-Hogdkins Lymphoma a blood cancer. Despite the increase in cases linked to breast implants, this is still a relatively rare type of cancer and women with implants should look for signs of the disease which includes pain, redness and swelling around the implant or breast area.

Dr. Andrea Pusic explains if and how breast implants can be dangerous

History of Breast Implants Being Linked To Cancer

Over 300,000 women in the U.S. get breast implants each year, and this includes breast cancer survivors who go through breast reconstruction surgery after a mastectomy. Researchers have found a link between breast implants and BIA-ALCL since 2011, but further evidence of rising cases has prompted both the FDA and doctors to take action in helping women assess the risk of a cancer diagnosis.

In 2019, data revealed that textured implants were directly linked to an increase in BIA-ALCL, which prompted the products to be recalled worldwide. Due to an increase of diagnoses, and mortality rates, the FDA has urged women to gather as much information as possible if they have, or plan to get, implants.

In order to help, the FDA has been urging doctors, physicians, and plastic surgeons to thoroughly go over the risks associated with breast cancer implants. Additionally, the agency released proposed guidelines for implant manufactures which includes a safety warning on boxes, a checklist of health risks, the impact silicone implants have on screenings, and more.

"The use of any foreign object in the human body has potential risks, Dr. Dung Nguyen, Director of Breast Reconstruction at Stanford Medicine, tells SurvivorNet. "Some are rare and are not known until years after they are in clinical use. It is our professional responsibility to inform our patients of these risks and any changes to them as our experience with the device broadens. The goal is not to cause a mass scare, but to provide evidence-based information in a relatable way so that women can make educated decisions about the use of breast implants for themselves."

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