The federal agency issued the guidelines after it received reports from 359 women claiming a link between their implants and their diagnosis of ALCL, a rare form of non-Hodgkin’s lymphoma. Non-Hodgkin lymphoma (NHL) is a group of blood cancers that includes all types of lymphoma except Hodgkin’s lymphomas. As of February 1, 2017, nine of those women had died.
Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
Silicone gel-filled breast implants are approved for breast augmentation in women aged 22 or older and for breast reconstruction in women of any age.
A breast implant is a prosthesis used to change the size, shape, and contour of a woman’s breast, for reconstructive plastic surgery, post-mastectomy breast reconstruction, congenital defects, among others.
The ‘mailonline’ reports that the FDA update marks something of a triumph for US medical researchers, six years after the World Health Organisation (WHO) first warned of the potential link. Last year, French regulators became the first to acknowledge the ‘clearly established link,’ ordering manufacturers to prove the safety of their products or take them off the shelf.
The UK Medicines and Healthcare Products Regulatory Agency was still analysing the French and American reports and was yet to acknowledge the ‘clearly established link.’
“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,” the FDA said yesterday.
“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,” it said. 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).
