Textured Breast Implants Linked to Rare Form of Cancer
Allergan has been asked by the Food and Drug Administration (FDA) to recall its textured breast implants, according to a report from late July 2019. The request for a recall comes after the FDA learned that there is an increased risk for a certain form of rare cancer associated with these breast implants. The FDA said that it has seen a significant increase in cases of anaplastic large cell lymphoma associated with breast implants. This cancer affects the immune system.
In a press release, the Principal Deputy Commissioner of the FDA, Amy Abernethy, said the following:
“Overall incidence of this type of cancer is low, but Allergan’s textured implants appeared to be directly linked to significant patient harm, including death. Based on new data, our team concluded that action is necessary at this time to protect the public health.”
In response to the request by the FDA, Allergan agreed to take its Biocell textured breast implants off the market. Allergan is headquartered in Dublin, Ireland. Hearings were held by the FDA in March, but had not decided to issue a recall for the breast implants. There have been more than 24 countries to recall the implants already, including Australia, Canada and France.
Cases Identified by the FDA
There have been 573 cases of large cell lymphoma identified so far, including 116 that have occurred since February 2019. According to the FDA, 481 of the cases can be attributed to the Allergan textured breast implants.
The FDA went on to say that 33 women have died from large cell lymphoma. In 13 deaths where a manufacturer of breast plants was identified, Allergan appeared in 12 of the cases when the woman was diagnosed with cancer.
Despite the recall request from the FDA, the agency does not recommend women with Allergan textured breast implants have them removed if they are not experiencing any symptoms. Doing so could lead to unnecessary risks.
FDA data shows that 5 percent of all breast implants sold in the United States are textured breast implants.
What is Being Recalled?
Allergan has announced that it will recall the following breast implants:
- Biocell saline filled textured implants
- Biocell silicone filled textured implants
- Biocell saline and silicone filled tissue expanders
Allergan said that these products will no longer be manufactured and will not be sold anymore. The company also said that doctors should stop using these products immediately and return unused product to the company.
Symptoms to Monitor
A plastic surgeon from Texas, Dr. Elisabeth Potter, cares for women who are diagnosed with cancer after receiving textured breast implants. Dr. Potter said that any woman who has textured breast implants needs to consult with their doctor and monitor for the following symptoms:
- Anything out of the ordinary
Potter said the following about the recall: “It was influenced by folks speaking up when the FDA didn’t act quickly enough. The power is now back in a woman’s hands, and the FDA is backing her up.
Potter, along with other medical professionals, believe that the FDA will issue more voluntary recalls of textured breast implants from other companies in the near future.
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