Published on September 17, 2020
Are Breast Implants Harmful?
The U.S. Food and Drug Administration (FDA) has published new data on the harmful side effects associated with breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a type of non-Hodgkin lymphoma, and breast implant illness (BII), a collection of symptoms, such as chest pain, chills, fatigue and memory loss that some women report after receiving implants.
There were 160 cases of BIA-ALCL and three deaths from July 7, 2019, to January 5, 2020. That brings the total cases to 733 and 36 deaths; 620 cases are tied to Allergan implants.
“The FDA has been diligently monitoring adverse events associated with breast implants for decades and has been working to better understand the quality of life and satisfaction a breast reconstruction patient may experience in order to refine our evaluation of breast implant benefits and risks,” Dr. Binita Ashar, director of the Office of Surgical and Infection Control Devices in the Center for Devices and Radiological Health, said in an FDA press release announcing the update.
While the overall incidence of BIA-ALCL is low, it can be fatal if not diagnosed and treated early, according to the FDA. In most cases, it is found in the scar tissue and fluid near the implant. However, it can spread throughout the body. Treatment options include surgery to remove the implant and the surrounding scar tissue or radiation and chemotherapy.
Allergan Breast Implant Recall
In late July 2019, Allergan launched a global recall of its textured breast implants — including in its Biocell and Natrelle product lines of saline- and silicone-filled implants and tissue expanders — after the FDA saw a spike in BIA-ALCL cases.
In terms of BII, reports totaled nearly 2,500 from November 2018 to October 2019, an increase of 1,080 reports from January 2008 to October 2018, the FDA said. The agency attributed the increase in part to a growing awareness of BII driven by the press, social media, and the FDA’s General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.
“While the FDA doesn't have definitive evidence demonstrating breast implants cause these symptoms, the current evidence supports that some patients experience systemic symptoms that may resolve when their breast implants are removed,” the FDA said.
What Are the Symptoms of Breast Implant Illness?
According to the FDA, the top 10 most common symptoms reported by patients with breast implants include:
- fatigue (49%)
- brain fog (25%)
- joint pain (25%)
- anxiety (24%)
- hair loss (21%)
- depression (19%)
- rash (18%)
- autoimmune diseases (18%)
- inflammation (18%)
- weight problems (18%)
Breast Cancer Patients Opting to Go Flat
The awareness of BIA-ALCL and BII may be a contributing factor to the increasing number of breast cancer patients who are opting to go flat — about 25 percent.
“There’s a growing percentage of patients who just say, ‘Why do I need to do anything?’” said Dr. Deanna J. Attai, a breast surgeon at UCLA and a past president of the American Society of Breast Surgeons, in a previous interview with Patient Power. "'Why can’t I just have my breasts removed because they need to be due to the cancer or an inherited mutation?' What I hear from women is ‘I’m not defined by my breasts.'"
FDA Guidelines and Recommendations
In October 2019, the FDA issued a draft guidance of labeling recommendations for implant manufacturers including a boxed warning, a patient decision checklist, materials/device descriptions, including types and quantities of chemicals and heavy metals found in or released by breast implants, and silicone gel-filled breast implant rupture screening recommendations.
When final, the recommendations will supplement or, in some cases, replace recommendations in the FDA's Saline, Silicone Gel, and Alternative Breast Implants guidance, issued November 17, 2006. The FDA has also released a video on seven things patients should know about breast implants, including risks, complications and information about BIA-ALCL and systemic symptoms.
Patients are encouraged to report any adverse events related to breast implants to the agency’s Adverse Event Reporting Program.
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- FDA Updates Analysis of Medical Device Reports of Breast Implant Illness and Breast Implant-Associated Lymphoma
- Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
- Saline, Silicone Gel, and Alternative Breast Implants
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