There has been an increase breast implant-related cancer cases, according to a new report from the FDA.
The Food and Drug Administration’s official count of implant-related cancer cases rose 15 percent in the last year as more research into the causes has come out.
Almost all of the cases reported have been in women who have textured implants as opposed to smooth ones, according to a study published by the Penn State College of Medicine in October.
Advocates for women with the disease have been pushing for the FDA to discourage getting textured implants, but the agency claims it still doesn’t have enough evidence to advise against them.
The FDA has reported an increase in the number of breast implant-related cancers known as BIA-ALCL. The diagram above shows where the lymphoma cells form in affected patients
About 450,000 women in the US get implants each year, and the chances of developing implant-related cancer range from one in 30,000 to one in less than 4,000, the FDA claims.
The cancer, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), is typically found in the scar tissue and fluid near the implant but can spread to other parts of the body.
Despite its location, BIA-ALCL is not a breast cancer but is a type of non-Hodgkin’s lymphoma, a cancer of the immune system.
The FDA began publicly reporting the number of cases from the US and other countries in 2011 when it identified a link between implants and the cancer.
In the past year the number of cases rose from 359 to 414 while the number of deaths remains at nine.
Last year the FDA stopped referring to the lymphoma as ‘rare’, clarifying that the rise in number of cases may be attributed to increased awareness of diagnosis.
When detected early, the lymphoma can usually be cured by removing the implant and the scar tissue around it. In more severe cases chemotherapy and radiation may be necessary.
Controversy over number of cases
There have been doubts about the accuracy of the FDA’s case count because it is based on voluntary data.
Another list compiled by a professional society of plastic surgeons indicates the number of cases worldwide is about 500, with 16 verified deaths, five from the US.
The FDA says that the precise risks of the cancer are difficult to determine because of a lack of patient data in the US and worldwide.
Stephanie Caccomo, a spokeswoman for the FDA, told Daily Mail Online: ‘We recognize the limits in the current medical device reporting system
‘Our surveillance of BIA-ALCL is ongoing and as such we will continue to communicate information about this lymphoma in the future.’
The main symptom of the cancer is swelling around the implant, which can occur from two to 28 years after the surgery.
The FDA has said that for women without any symptoms, there’s no reason to screen for the disease or have the implants removed.
The Penn State study found that almost all of the cases reported are in women who have textured implants as opposed to smooth ones.
Textured implants became popular in the 1990s and patients choose them because their surfaces adhere to the tissue surrounding them allowing them to stay in place in the breast pocket.
The researchers suggested that the textured coating on the implants could cause inflammation in the surrounding tissue that leads to the cancer.
Another possible reason is that the texturing traps bacteria, increasing the risk of infection that leads to the cancer.
The FDA report mentioned the increased likelihood of developing lymphoma from the textured implants, but there is not enough research or evidence to suggest that the texture is a direct cause.
In 2015 French health officials made it a requirement for all breast implants to come with health warnings after the country’s National Cancer Institute declared a: ‘clearly established link’ between the implants and BIA-ALCL.
Just a few years earlier in 2011 it was revealed that one of France’s top implant manufacturers, French firm Poly Implant Prothese (PIP), had been filling implants with industrial grade silicone intended for use in mattresses.