Everything you need to know about breast implant illness
What’s the Problem?
Earlier in March, the Food and Drug Administration issued a statement explaining that many implants or insertable devices–from pacemakers to breast implants–may trigger allergic reactions or lead to sickness for some people. This happens, the FDA report explains, because with any foreign substance entering the body, it can have adverse reactions in some bodies, despite various testing done beforehand. This week, March 25th and 26th, the FDA held a meeting with a General and Plastic Surgery Devices Panel at the FDA’s Headquarters in Silver Spring, Maryland to discuss the risks of breast implants. According the their website, they discussed the following:
(1) Breast implant associated anaplastic large cell lymphoma (BIA-ALCL); (2) systemic symptoms reported in patients receiving breast implants; (3) the use of registries for breast implant surveillance; (4) magnetic resonance imaging screening for silent rupture of silicone gel filled breast implants; (5) the use of surgical mesh in breast procedures such as breast reconstruction and mastopexy; (6) the use of real-world data and patient perspectives in regulatory decision making, and (7) best practices for informed consent discussions between patients and clinicians.
What is Breast Implant Illness?
Breast implant illness is a series of symptoms that women who have implants suffer from. While the FDA insists there is not enough evidence proving these varying symptoms are caused by the implants, various support groups and even some national studies have shown data that supports the existence and severity of breast implant illness.
According to the American Society of Plastic Surgeons, in 2017 alone there were 300,378 breast augmentation surgeries. By 2019, millions of women have breast implants. There are two kinds of implants: a silicone sac filled with sterile salt water or filled with silicone gel. While the gel tends to feel more natural, there is higher risk for rupture which can be damaging to the body.
Though many women love their implants, those suffering from breast implant illness experience:
* Breast pain or irritation
* Rash or itchiness
* Panic Attacks
* Memory Loss or a “foggy head”
And in the most severe cases, it can be tied to
* Autoimmune diseases
* Connective tissue symptoms
The Studies so Far:
1. In January 2019, The Annals of Surgery published a study the University of Texas MD Anderson Cancer Center ran a study with 99,993 patients over seven years. The results found that compared to normative data, silicone implants are associated with Sjogren’s Syndrome, scleroderma, rheumatoid arthritis, stillbirth, and melanoma. The study concludes that more research needs to be done with both silicone gel and saline-filled implants to further evidence of implant-related illnesses.
2. In this study from 2005, Katzin et al. found that in 74% of patients with implants, silicone had traveled to the lymph nodes. This sample size was much smaller than the above study, with only 96 patients with implants and 12 control without. This migration is cause for concern and questioning what effects silicone has on the body.
3. Older studies supported by the FDA have since been found too small, short, or biased to be useful. Often patients dropped out and results remained inconclusive. The New York Times reported that many of these earlier studies were funded by implant companies or plastic surgery associations, and therefore cannot be considered reliable.
These figures show that there is a need for more information and an overall increase in longitudinal studies surrounding the issues of breast implants. Much of the details and personal experiences of people suffering from this illness can be found through articles, informal blogs or Facebook groups instead of through those responsible.
Dr. Diana Zuckerman, president of the National Center for Health Research stated, “Many women have reported that their debilitating autoimmune symptoms decreased or disappeared after their breast implants were removed, but scientific data is needed to establish the rate of recovery.” This means that for many women, having the implants removed helped rid them of nearly all of their symptoms.
For women with Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), treatment will involve surgery to remove the implants and any infected tissue and possibly even chemotherapy and radiation.
More information on your treatment options for BIA-ALCL can be found here. Be sure to speak with your doctor if you notice any of the above symptoms. Oftentimes breast implant issues can go unnoticed or undocumented because patients don’t think a rash or stiffness of the breasts is serious or that it will go away on its own. Always keep your doctor updated with any changes you find so he or she can run necessary tests to make sure you’re healthy.
Breast Implant Illness remains a mysterious and complicated disease. As the data suggests, there will be more research surrounding the illness that will hopefully give more concluding answers. If you or someone you know is experiencing symptoms of breast implant illness, the best option is to talk to your doctor or surgeon about your symptoms and decide together what treatment option is best for you.