The Food and Drug Administration (FDA) has revealed it has received an increase in reports of breast implants linked to a deadly cancer.
Of the 660 reports, 457 individual women have been diagnosed with anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkins lymphoma, with nine reported deaths.
The number of unique cases is lower than the total number of reports, of which there has been an increase of 246 because of how the FDA’s reporting system works.
In a statement on the FDA’s website, Binita Ashar, M.D, of the FDA’s Center for Devices and Radiological Health, said: “Unfortunately, not every report provides thorough information about each case, including what type of breast implant (e.g., surface texture) the patient received, which makes it more difficult to know if any particular breast implant characteristic is associated with BIA-ALCL or if higher reports of BIA-ALCL are simply due to higher implantation rate of a particular manufacturer.
“For patients, we know the information regarding breast implants can be overwhelming, which is why we are committed to continuing our efforts to provide up-to-date publicly available resources to help understand the known benefits and risks of implants. We encourage patients to review our website and read specific device labelling, including patient labelling information, for any product they may consider implanting. Choosing to obtain a breast implant is a very personal decision that patients and their providers should make based on individual needs and with the most complete information about products.
“We are also aware that our counterparts in different countries are taking certain actions or may be reporting different information about breast implant safety than the FDA. The different devices approved in each country, availability of products, variation in market share, extent of medical device adverse event reporting, and availability of information regarding the total number of implants sold differs from country to country. This makes it difficult for the regulatory bodies of different countries to compare data and determine risk rates on a global scale.”
