Breast Implant Removal 'Not Recommended' For Asymptomatic Patients: FDA
- The U.S. Food and Drug Administration (FDA) recently advised that the removal of textured breast implants to prevent cancer is “not recommended” for asymptomatic patients.
- The FDA’s statement was made in response to an expert panel formed by the American Association of Plastic Surgeons (AAPS) conducting a review on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), saying the preventative removal of macro textured breast implants “can be deemed reasonable” due to a possibility of risk infection.
- Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of blood cancer called non-Hodgkins lymphoma and it is not breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant or breast area.
- NASCAR Legend Danica Patrick previously underwent breast implant removal surgery after developing breast implant illness (BII), a condition with symptoms that include fatigue, joint pain, memory and concentration problems, and more.
The FDA made it’s statement in response to an expert panel formed by the American Association of Plastic Surgeons (AAPS) conducting a review on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), which was published in the Plastic and Reconstructive Surgery several months ago.
Read MoreThe FDA adds, “Textured breast implants overall are less common in the U.S. compared to other countries. Prophylactic surgery presents a range of risks depending on individual patient risk factors including history and anatomy. Additionally, there are different types of breast implants currently marketed in the U.S. and risks vary by type of implant and patient characteristics.
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“In most cases, BIA-ALCL is found in the scar tissue and fluid around the implant. However, in some cases, it can spread throughout the body. While uncommon, a BIA-ALCL diagnosis is serious and can lead to death if not diagnosed early and promptly treated. We encourage patients and providers to report any issues related to breast implants to the FDA’s Adverse Event Reporting Program.”
Breast Implant-Associated Anaplastic Large Cell Lymphoma or BIA-ALCL, is a type of blood cancer called non-Hodgkins lymphoma and it is not breast cancer. It is rare, and symptoms include pain, redness and swelling around the implant or breast area.
The CDRH’s “Continued Commitment to Breast Implant Safety” comes three years after the FDA issued “new orders restricting sales and distribution of breast implants and approved new labeling to ensure consumers are equipped with the information they need to make informed decisions.”
Additionally, in 2022 and 2023, the FDA offered new information on breast implant safety, regarding Squamous Cell Carcinoma, various lymphomas in addition to BIA-ALCL, and different malignancies of the breast in patients with breast implants.
Danica Patrick’s Breast Implant Journey
Most people who decide to get breast implants for cosmetic or reconstructive purposes do quite well after the procedure. But sadly others, like Danica Patrick will have a different experience by developing breast implant illness. Thankfully, having her breasts implants removed has led Patrick down a path to recovery and newfound confidence.
Patrick first decided to get breast implants back in November 2014 in order to attain “an ideal body.”
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Speaking to PEOPLE in 2022 about her experience, she said in retrospect, “I think the idea of perfection in of itself is a really dangerous goal.”
Just a few years after her implants were placed, Patrick began experiencing fatigue, weight gain and hair loss.
Doctors ultimately came to the conclusion that she had breast implant illness, or BII, a diagnosis that led Patrick to undergo breast implant removal in March 2022.
“My surgery was at two-thirty in the afternoon, so home by five-ish,” Patrick said of the “insanely easy” surgery. “After that, I mean, I took a pain pill when I went to bed, and I think I took one in the morning and that was it for pain pills other than two more Tylenol.”
Since removal, Patrick has been a slow-moving recovery path.
“I think my body is again, still healing,” Patrick told PEOPLE in October 2022. “It’a been about six months since the implants have been removed. It’s about your lifestyle and mind and just really giving the body a chance to recover.”
Despite being used to moving fast, she has since made a point to slow down and give her body the rest it needs.
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“I actually think it’s more wise for me to give myself a good year or two timeline (to see where) I land after a year or two of allowing my body and my mind to really reach a place of health and balance and recovery really from how much time my body spent fighting for me,” Patrick said at the time. “And it did a really, really, really good job. Now it’s time for me to consciously and actively fight back for it with being smart and kind to myself.”
“I’m trying to be sort of careful with my workouts and doing more walking and not so much high intensity. So, lifting and walking really are the bulk of it.”
She was also happy to see her implants go for reasons beyond her breast implant illness.
“The work in loving yourself just like you are and not falling to the idea of perfection,” she said. “I actually like how I look better after… So, there you go.”
Breast Implants & Cancer
Questions surrounding whether breast implants themselves cause cancer have remained for years. Just last year, the FDA released safety communication regarding the potential risks of squamous cell carcinoma (SCC) and lymphoma, a type of cancer that starts in the lymphatic system.
SCC is among the most common types of skin cancer. According to the Centers for Disease Control and Prevention, squamous cells are “thin, flat cells that form the top layer of the epidermis.” This skin cancer type isn’t life-threatening and grows slowly, according to the American Academy of Dermatology Association.
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The FDA’s safety communication indicated it received ten medical device reports about squamous cell carcinoma. A medical device reporting is a method the FDA uses to collect and analyze data about a marketed device scientifically. The federal agency says it also received 12 reports about varying types of lymphomas related to breast implants.
“The report states that the FDA is aware of 19 cases of SCC in the capsule around the breast implant from published literature,” noting the information includes the FDA’s review of medical literature and reports. “There have been reports in the literature of deaths from progression of the disease. While the FDA continues to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence, and risk factors remain unknown.”
Are Breast Implants Dangerous?
The warning follows previous reports of SCC and various lymphomas (cancer of the immune system) related to breast implants. The various lymphomas noted differ from those previously described by the FDA as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
The FDA pinpointed textured implant manufacturer Allergan to remove some of its textured breast implants and tissue expanders from the market amid its report.
“Based on the currently available information, including data submitted in 2019, our analysis demonstrates that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S.,” an FDA spokesperson wrote to SurvivorNet in an email. A complete list of recalled styles can be found via the FDA’s website.
Doctors Weigh In On Breast Implant Concerns
In an earlier interview with SurvivorNet, Dr. Sarah Cate, the lead physician for the Special Surveillance Breast Program at Mount Sinai Beth Israel, and Dr. Jordan Jacobs, a plastic and reconstructive surgeon, discussed breast implant concerns for survivors of breast cancer, following the release of an FDA safety communication. The FDA received 10 medical device reports (MDRs) about squamous cell carcinoma and 12 reports about various lymphomas connected to breast implants.
Doctors Cate and Jacobs tell SurvivorNet, regarding the FDA safety communication, “personally don’t think there is cause for alarm.”
The doctors believe the data shared by the FDA does not conclusively tie breast cancer to implants. Although, the pair does say, “the fact that the cancers were found in the implant capsules is certainly concerning and requires further investigation.”
Dr. Cate and Dr. Jacobs note how the FDA has required the placement of warnings on breast implant packaging. Additionally, there is newly an implant checklist that patients must sign and review before undergoing implant surgery. The doctors noted how ALCL, a rare form of non-Hodgkin lymphoma, has been associated with implants for years.
The doctors affirmed that textured implants, those linked to ALCL, are not used at Mount Sinai. The doctors also note that implants require monitoring, and that if there are an adverse conditions spotted after the implants, they should be reported to the FDA.
Dr. Cate and Dr. Jacobs tell SurvivorNet, “Patients who have implants placed for either cosmetic or reconstructive purposes should have yearly follow-ups with their surgeons.” They add that “there are recommendations from the FDA for routine (every 2-3 years) MRIs to evaluate the integrity of the implant and the surrounding capsule.”
It’s important to note that most women who get breast implants do not get the textured kind that’s linked to cancer. The more popular option is “smooth” implants, which are usually filled with either silicone or saline. Unlike textured implants, smooth ones have not been linked to cancer. However, smooth implants have previously had potential complications reported in the past, such as joint pain, muscle aches, confusion, chronic fatigue, and autoimmune diseases.
“The use of any foreign object in the human body has potential risks,” Dr. Dung Nguyen, Director of Breast Reconstruction at Stanford Medicine, told SurvivorNet in an earlier interview.
“Some are rare and are not known until years after they are in clinical use. It is our professional responsibility to inform our patients of these risks and any changes to them as our experience with the device broadens. The goal is not to cause a mass scare, but to provide evidence-based information in a relatable way so that women can make educated decisions about the use of breast implants for themselves.”
It’s important to note that the medical community has a consensus that women between 45 and 54 have annual mammograms. However, an independent panel of experts called the U.S. Preventive Services Task Force (USPSTF) says that women should start getting mammograms every other year at the age of 40, suggesting that this lowered the age for breast cancer screening could save 19% more lives. For women aged 55 and older, the American Cancer Society recommends getting a mammogram every other year. However, women in this age group who want added reassurance can still get annual mammograms.
When Should You Be Concerned About Your Implants?
Moreover, there are signs of cancer that Dr. Cate and Dr. Jacobs want people with breast implants to keep an eye out for. If anyone with implants present the following symptoms, they should contact their physician:
- Breast swelling
- Pain
- Redness
- Tightening
- A change in the shape of their breasts
If you do find yourself in a situation where an evaluation of your implants is needed, you will undergo a physical exam and imaging studies “to evaluate the implant shell integrity, determine if there is fluid around the implant and visualize the implant capsule.” Most breast radiologists can perform sampling fluid, as well, so that the fluid can be examined to see if there are any abnormal cells present.
“Surgical management includes removal of the implant and the surrounding capsule, which is sent to pathology to rule out atypical cells and/or cancer,” Dr. Cate and Dr. Jacobs added.
Contributing: SurvivorNet Staff
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