France Bans Breast Implants Amid Cancer Suspicions
As of Thursday, specific types of breast implants – namely those with a textured or polyurethane coating – are no longer allowed in France. The ban of these implants are due to concerns that they have the potential to cause a type of cancer called anaplastic large cell lymphoma (BIA-ALCL). In finalizing the ban, France has become the first country ever to do so. According to Eyewitness News, the National Agency for Medicines and Health Products (ANSM) called the ban a “precautionary measure” which was taken due to the “rare but serious danger” caused by the implants.
It is estimated that approximately 70 000 French women currently have the banned implants, but it is not recommended that they have “explant” surgery to have them removed. Out of an estimated 500 000 women who have undergone breast augmentation that includes different types of breast implants, 59 cases of ALCL have been reported. As of yet, three women have died from cancer. However, the ANSM said in a statement that they had not identified “any immediate risk to the health of women carrying the implants concerned.” As reported by Euronews, after the ANSM consulted with experts, they came to the conclusion that the more “textured and rough” the implants, the greater the risk of developing the disease.
In addition, earlier this year, the most popular breast implants from the pharmaceutical company, Allergan, was withdrawn from the market in Europe, while December 2018 saw ANSM in France ordering the company to cease manufacturing and selling its Microcell and Miocell implants. Both of these types of breast implants are textured. With this week’s ban in France, Allergan’s Biocell implants will also be removed. In addition to Allergan, five more implant manufacturers will be affected by this ban, including Arion, Sebbin, Nagor, Eurosilicone, and Polytech.
What is BIA-ALCL?
It is not breast cancer. When presenting with breast implants, this cancer of the immune system (Hodgkin’s lymphoma) is typically found inside a capsule of fibrous scar tissue instead of inside the surrounding breast tissue. Research indicates that they are found more frequently in textured breast implants than smooth implants. As of yet, the type of filling does not seem to have an influence on this. It develops when white blood cells, known as T-cells, become abnormal in nature. They are typically present in the lymph nodes but have been known to affect other areas of the body. Click here to find out the reports from Harvard Health on this cancer relating to breast implants.
In the US, the FDA classifies this disease as a “known risk of breast implants.”
In addition, the agency communicated on this issue as early as 2011. According to Binita Ashar, MD, general surgeon and the director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health, the FDA was the first public agency to warn the public about the risks for women with breast implants to develop this disease. In a press announcement that was released in February this year, results from an updated analysis of BIA-ALCL indicate that in the US, 457 women have been affected by this cancer, with the first documented case reported in 1997. 9 related deaths have been recorded.
The guidelines of the National Comprehensive Cancer Center (NCCN) that covers the diagnosis and treatment of BIA-ALCL state that the majority of women with this disease present with “a large spontaneous perioprosthetic fluid collection occuring at least 1 year and on average 7-10 years following cosmetic or reconstructive implantation following cosmetic or reconstructive implantation with a textured surface implant.”
Going forward on this issue
The same guidelines have indicated that early diagnosis and treatment of the disease is usually associated with “excellent prognosis”. Metastasis has, however, been reported. In addition, the importance of initial ultrasound evaluation of women presenting with signs and symptoms of BIA-ALCL has been emphasized, and the NCCN recommends fine-needle aspiration as the method of fluid sampling.
“We hope that this information prompts providers and patients to have important and informed conversations about breast implants and the risk of BIA-ALCL. “At the same time, we remain committed to working in partnership with all stakeholders to continue to study, understand, and provide updates about this important public health issue,”. Dr Ashar wrote.
When it comes to patients, the FDA recommends that each person take the responsibility to educate themselves before agreeing to surgery. “Before getting breast implants,” the agency said in a statement, “make sure to talk to your health care provider about the benefits and risks of both textured-surface and smooth-surface implants. Additional information is available on the FDA’s Breast Implants website.
Want to know more?
After their arrival on the cosmetic-surgery market in the 1960s, both silicone and saline breast implants quickly became the most popular plastic surgery procedures for women. According to the American Society of Plastic Surgeons, breast augmentation is still the number one surgical procedure for women. It ranks above liposuction, nose reshaping, eyelid surgery and a tummy tuck. The problem, explains Dr. Diana Zuckerman, Ph.D., and President of the National Centre for Health Research in the United States, is that surgeons who administer breast implants often minimize the risks associated with this procedure. Consequently, the majority of women don’t realize that a few years after the procedure, they may need to have their implants removed. Additionally, they are unaware that removal costs at least as much as implantation.
Now, about 50 years after breast implants were first introduced globally, un-tracked numbers of women are complaining of a recognizable pattern of health problems, which they attribute to their implants. Those suffering from these symptoms generally refer to the condition as Breast Implant Illness or BII (although non-medical, this term is widely used). Various social media groups and organizations have been formed by these women, most notably Healing Breast Implant Illness and The Implant Truth Survivors.
Implants Can Cause An Autoimmune Reaction
Symptoms of this condition – which Dr. Zuckerman explains, is a pattern of health problems likely caused by an autoimmune reaction to the implant – include mental confusion, joint pain, hair loss, dry eyes, chronic fatigue, and persistent flu-like symptoms. “In some cases,” she says, “silicone gel is leaking into their bodies and causing the autoimmune reaction. When the gel leaks into organs such as the lungs and liver, it can’t be removed surgically.” Click on the link to find out more about this condition and why it is gaining recognition.