The following is a synopsis of the article “Silicone Implant Illness: Science Versus Myth, written by Rohrich, Kaplan and Dayan, and published in Plastic and Reconstructive Surgery this year. (Plast Reconstr Surg. 2019;144(1):98-109.) This is the best article I have ever read that addresses this issue so comprehensively and without bias.
Breast implant illness has been a controversial topic for several decades. I wish to review the current base of knowledge and opinion regarding the safety of silicone breast implants. The reason that silicone gel breast implants are currently available is that scientific evidence strongly supports the safety of these devices. It is the patient’s decision to obtain, keep, or remove breast implants. Should you decide to have your breast implants removed, then you will be best served by consulting with a board-certified plastic surgeon with expertise in breast surgery. Breast implants are the most thoroughly studied medical devices in history, and the desire and need to continue this research continues to this day. Research continues to look for any connection to cancer and autoimmune disorders, to make certain that breast implants are safe. Patient education and awareness are also extremely important to make certain that correct information is disseminated.
There is a lot of information on the internet concerning an entity called “breast implant illness” or “silicone implant illness.” There are numerous reports of women who have a vague constellation of symptoms that seem to get better when they had their implants removed. Unfortunately, this type of evidence is not conclusive proof of this disorder, or any other disorder.
Properly conducted research and clinical studies follow strict methodology to make certain that the conclusions drawn from the data presented are correct to a high level of probability. There are no such studies that prove that breast implant illness is a real entity. There are also no studies that prove that it is not a real disease, either. The mere reporting by individuals that state that their symptoms were relieved by removal of breast implants unfortunately is not adequate proof that breast implant illness is real.
I am not presenting this information to defend silicone implants. Rather, I am trying to provide the most up to date scientific evidence to educate my patients and website visitors. You can draw your own conclusions from the material that follows.
Silicone breast implants are used in nearly 300,000 breast augmentation and 100,000 breast reconstruction operations annually in the United States. Silicone gel–filled implants were first approved by the U.S. Food and Drug Administration in 1962. Since that time, few medical devices have been studied as closely for their safety and associated adverse outcomes. Despite multiple generations of implant shells and gel fillers, the basic components remain as originally designed.[2,3]
Silicone breast implants are used in 300,000 breast augmentations and 100,000 breast reconstructions every year in this country. The very first breast implants were approved by the FDA (Food and Drug Administration) in 1962. There have been substantial improvements in silicone technology and the resulting breast implants since the first ones were created. There are no medical devices subjected to as much scientific study as breast implants.
During the 1980’s and early 1990’s, concern grew as to the safety of breast implants, eventually culminating in a moratorium on silicone breast implants. The FDA opened the door towards re-approval of these devices but required properly controlled scientific studies to document the safety of these implants AND post approval studies to monitor these devices carefully to fully ensure breast implant safety. In 2006, silicone breast implants were approved once again.
Numerous scientific studies have been published with none showing any evidence that patients with silicone implants have an increased risk of developing cancer or any kind. A very large study examining long-term safety of women with Natrelle round silicone gel–filled breast implants was conducted by multiple investigators at many difference medical centers was published in 2017. The study population of 55,279 women showed no excess risk for any cancer diagnoses including brain, cervical/vulvar, lung, or breast cancer.
Anaplastic Large Cell Lymphoma
Several reports in the medical and scientific literature have suggested a possible connection between textured breast implants and a rare type of non-Hodgkin’s lymphoma called anaplastic large cell lymphoma (ALCL). A textured implant is a type of breast implant that can be filled with either saline or silicone, and has a roughened surface externally which has been created for the purpose of keeping the implant from shifting within the breast, as well as to reduce the risk of capsule contracture (a benign condition of the breast where the normal scar tissue capsule that forms around all breast implants suddenly becomes thick and tightens around the implant, making the breast feel hard). A 2018 FDA update reported 414 such cases of ALCL in the U.S. The risk of developing ALCL is thought to vary somewhere between 1 in 3800 to 1 in 30,000 women with textured implants. Although some deaths have occurred due to ALCL, it is felt that many of these were early in the study of this illness where the disease process was not yet understood, or, in the case where women did not seek medical attention early and the disease progressed unchecked. ALCL is NOT breast cancer, but rather is a malignancy that forms in the scar tissue capsule that forms around all breast implants. Note that there are no reported cases of ALCL in women who have only had smooth surface breast implants.
Connective Tissue Disease
Numerous studies seeking to determine whether or not there is an association between silicone breast implants and connective tissue disease have failed to prove a connection between the two.
There has been no study to show an association between silicone breast implants and suicide nor depression.
There have been numerous case reports that patients with silicone breast implants who had subsequently developed various neurologic symptoms or disorders. This is not evidence enough to demonstrate an association between silicone implants and these disorders. These conditions included multiple sclerosis, “multiple sclerosis type syndrome,” both motor and peripheral neuropathies, and “atypical neurologic disease syndrome.” There has been no studies to date which show a connection between silicone implants and these neurologic disorders.
Early case reports of isolated adverse health outcomes in children born to mothers with silicone breast implants were published in the 1990’s. Such conditions included difficulty swallowing, irritability, nonspecific rashes, and fatigue, among other symptoms. Subsequent studies have failed to demonstrate any relationship between silicone breast implants and these disorders.
Few medical devices have undergone the degree of scrutiny and scientific investigation to ensure safety that silicone breast implants have. Currently, there is overwhelming evidence supporting the safety of silicone breast implants. It is up to the patient to decide if they want to keep, remove or replace their textured breast implants with a smooth device. If a patient chooses to have her breast implants removed, it is important to find a board-certified plastic surgeon with expertise in breast surgery. If a patient chooses to have implants removed, she should consider having the entire capsule removed, unless the posterior capsule is adherent to the chest wall, which may increase the risk of a collapsed lung. In cases of ALCL or ruptured implants with thick calcified capsule, a total capsulectomy is recommended.
Studies should continue to collect and analyze data from silicone gel implant patients. However, the current state reveals that there are numerous scientifically sound studies in the medical literature that do not demonstrate any connection between silicone breast implants and “breast implant illness.”
The reader might feel that I am biased and presenting only information that absolves silicone gel filled implants from any connection to any disease process. However, I also have some “skin” in this game. My own daughter has textured silicone gel implants and she and I are both comfortable with this fact and see no reason to remove or exchange them at this time. She will undergo the recommended breast surveillance that all women with silicone breast implants undergo and knows to report to her doctor any changes in her breasts including unexplained swelling, a mass or other early sign of ALCL.
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Sections - BII - ALCL
Chapters – Breast Augmentation Guide
- Intro to Breast Augmentation
- Five key decisions you need to make
- One-Day Recovery Breast Augmentation
- Anesthesia – General, Sedation or Local?
- Will I need a breast lift (Mastopexy)?
- What else should I know about breast augmentation?
- Important Things to Consider When You Decide to Move Forward With Breast Augmentation
- Revision of breast augmentation
- ALCL and Breast Implant Illness
- Motiva Breast Implant Clinical Trial