"At that time, the FDA knew of so few cases of this disease that it was not possible to determine what factors increased the risk," said the agency.
Now, the information has been more substantial, and as of 1 February this year, a total of 359 medical reports of breast implant, including nine deaths linked with ALCL, have been received.
In a recent statement, the FDA said, "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.”
Surface of implant is more important than its contentALCL takes about an average of 10 years to develop after the first implant, and usually grows in the capsule of scar tissue around the implant, according to researchers of World Health Organisation (WHO). Symptoms include lumps, pain, swelling and fluid build-up. Though malignant, it is slow-growing, and with early detection, it is treatable.
"Most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation," the FDA explained.
The authority added that doctors should consider the possibility of lymphoma in women who start having breast problems a long time after the implant.
Most of the cancer cases occurred in people who had textured surfaces on their implants, rather than smooth surfaces. Of the 231 reports received, 203 had textured surfaces while 28 had smooth implants.
According to the FDA, breast implants approved in the US can be filled with either saline or with silicone gel. They come in different sizes and shapes and have either smooth or textured surfaces (shells).
The reason for the difference in risk related to the surfaces is still being investigated. The body reacts differently to textured surfaces and smooth implants, according to Dr Alex Wong, a plastic surgeon and researcher at the University of California’s Keck School of Medicine. In textured implants, tissue grows into microscopic grooves for the implant to stay in place.
“We’re still trying to find out why the surface matters,” said Wong, adding that in some cases the cancer was associated with a certain bacterial infection.
FDA’s breast-implant website lends support to women on risks and precautionsIn light of the associated risks with implants, the FDA has a breast-implant website that provides information on the risks involved, and support to help women make informed decisions. It encourages women to do some research before having breast implants.
“People who already have breast implants should monitor their implants for any changes and get routine screenings such as mammograms or MRIs as recommended by their doctors,” the FDA advised.
Ultimately, breast augmentation is here to stay, and according to the American Society of Plastic Surgeons, 290,467 procedures were performed in 2016.
Although about 10 to 11 million women in the world have breast implants, the American Society of Plastic Surgeons and the Plastic Surgeon Foundation reported that less than 10 patients each year are diagnosed with breast implant-associated ALCL, with one study estimating an incidence of one in 300,000.
The two bodies are currently compiling a list of implant patients who developed ALCL. On the group’s website, it said, "The research will also focus on identifying potential risk factors and criteria detection and management of this disease.”
“It’s important to remember that breast implants are not lifetime devices,” said Dr Jeffrey Shuren, director of the FDA’s Centre for Devices and Radiological Health.
“Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential.” MIMS
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