Breast Implant Informed Consent: Michigan, We Need Your Support!
This week marks the two year anniversary of over 80 warriors from all over the country traveling to DC to testify before the Food and Drug Administration with their personal breast implant illness experiences. These BII warriors called for labeling changes during a March 2019 FDA General and Plastic Surgery Devices Advisory Panel. These changes were to ensure that patients that were considering implants in the future would be fully informed of the potential dangers associated with them. This resulted in the FDA recommending that implant manufacturers use a boxed warning- the FDA’s strictest caution- to clearly show the risks of implants.
These passionate advocates were the women that led me to realize that the new and improved, “safe” breast implants placed during one of my many surgeries in my cancer treatment, were not so safe after all. I will be forever grateful for their voices!
Sadly, I am not alone when I say that my breast implants literally almost killed me.
Last year over 300,000 women had breast implants placed. When I think about how many of those women actually received true informed consent, and the manufacturer information on their breast implants, it makes me shudder. Many are still not being given this critical information freely. Many have reported not even being given the breast implant manufacturer information and Black Box Warning that comes with the implants. Most patients have reported that they were warned only of possible capsular contracture, or infection.
The Black Box Warning is the strictest labeling requirement that the FDA can mandate. It highlights serious and sometimes life-threatening adverse reactions within the labeling of the product or drug. It doesn’t matter if a patient wants implants for personal reasons, or if they are choosing to reconstruct, and were given the option of breast implants. Patients deserve accurate information about a device being implanted in their body. PERIOD. Every day, there are more women experiencing problems, ruptures, and leaks with their breast implants. Many are plagued with breast and chest muscle pain, infections, and capsular contracture. The scary fact is that many women do not realize that it is their breast implants causing, or contributing to their numerous illnesses. Or, they do not experience any noticeable symptoms yet. They are not aware of, and unfortunately many of their specialists have not had experience dealing with BII, or BIA-ALCL. (Breast Implant-Associated Anaplastic Large Cell Lymphoma)
BII, also known as Breast Implant Illness, is an autoimmune condition caused by any type of breast implant. Saline and silicone, as both of them have a silicone shell, and are foreign objects to the body. The textured and smooth types can both cause BII. This can result in severe brain fog, fatigue, headaches, rashes, and muscle and/or joint pain. Those symptoms are just the beginning for most patients. Many of us have had chronic blood pressure problems, either dangerously high, or dangerously low. Hair falling out, cognitive dysfunction, over stimulation to lights, sounds, and smells, the feeling of dying every day, unusual chemical body odor, severe night sweats and hot flashes, vertigo and balance issues, severe tinnitus, and a daily hung over feeling/morning sickness are all very common autoimmune and inflammatory responses to having breast implants. Many BII patients have up to a dozen or more specialists before they realize that their body is having some sort of inflammatory response to their implants.
Textured implants, particularly the Natrelle Biocell product line filled with either saline or silicone, have been linked to BIA-ALCL. As of January 2020, this cancer had been diagnosed in at least 733 patients. This cancer has killed over 36 patients, per the FDA. Multiple articles have noted that the main symptom of BIA-ALCL, which is swelling, doesn’t even occur until up to 7 to 8 years after implant placement. Without true informed consent, this can easily get blamed on weight gain and other factors, and be easily overlooked. Breast Implant Associated Anaplastic Large Cell Lymphoma can be easily treated, but it can also be fatal. Most BIA-ALCL cases have been with Allergan textured implants, but there is no evidence proving that all implants do not cause this cancer.
I did not beat multiple breast cancers, and survive chemo just to get put down by “safe” breast implants, and all of the chronic health conditions that they can cause. Not informing patients of life altering and threatening health problems caused by a device goes against the oath of “do no harm.” I know surgeons want their patients to be well informed. All patients deserve to be informed PRIOR to making a decision that could impact the rest of their life, and the lives around them. All plastic surgeons, like all doctors, should want the best case scenario for their patients, even if it means that a patient may not be a good candidate for a complex surgical procedure, let alone carry around a foreign body in their body.
Anyone thinking about utilizing these short term medical devices would receive true informed consent before their decision. This would include but is not limited to: A) Requiring licensed physicians to provide a patient with the following information either written, or electronically: 1) a description of the risks of breast implants and a description of the surgical procedures used in breast implant surgery; 2) manufacturer patient information materials on the implants to be used in the surgery, including FDA warning requirements; 3) an informed consent checklist for physicians to review with the patient prior to surgery that must include information on breast implant associated ALCL, breast implant illness and the NBIR; and 4) information on how a patient can report adverse effects associated with breast implants through the FDA MedWatch Program. B) Stipulates that, in addition to the breast implant surgery information requirements, a physician must obtain written informed consent from the patient before performing the surgery. There are also other provisions included. The checklist includes information on longevity of breast implant devices, many of the contraindications to breast implant surgery, disclosure of the heavy metals in breast implants, risks of rupture and leakage, Breast Implant Associated Anaplastic Large Cell Lymphoma and its treatment, symptoms of breast implant illness, risks of other systemic disease, capsular contracture, the interference of breast implants in MRIs and breast exams, interference of breast feeding, and the possible associated health complications in children that are breast fed by a mother with implants, loss of sensation, cosmetic complications, and information needed to report any adverse reactions or complications.
▪️Not everyone has these complications or reactions, but we ALL deserve to know the truth about what harm breast implants may cause prior to deciding to go through with this major surgery.
▪️Getting implants removed correctly is a very precise surgery and can be extremely complicated, not to mention expensive and often not covered by insurance. It can also be very hard for patients to find a skilled surgeon with explant/En Bloc procedure experience, which involves leaving the capsule tissue on the breast implant and cutting around it without disrupting the capsule or implant. This is done to remove all surrounding inflammatory tissue from the capsule. This also helps prevent any dangerous contamination that may lead to further illness, or the spread of silicone, bacteria, and mold throughout the patients chest cavity and body.
▪️Michigan, we need your support! Please take a few minutes of your time to contact your local state representative and tell them that you want them to support the informed consent for breast implants bill when it’s presented by Representative Julie Calley. Our representatives work hard for us, but they need to hear from their constituents!
▪️Please share your story, your wife’s story, your daughter, friend or mother’s story. Share my story. Just call and make a positive impact. These conditions impact the entire family. Please let your local state representative know that you support informed consent for breast implants, and would like their full support of our Informed Consent Bill for Breast Implants that will be presented in the near future.
▪️Below you will find the link for the information to contact your local state representative. Just put in your address and zip code to find your local state representative, and their contact information.
▪️Please write letters, send emails, and make multiple phone calls of support. You can do all of this more than once. We need calls, and support from all over the state! Raising our voices together can make a huge impact. Thank you in advance for your support.
▪️It doesn’t matter if patients choose to have an augmentation or reconstruction after cancer, they all deserve true informed consent. Each and every one of those 300,000 patients. This bill would be the first step in ensuring better informed decisions for our future. For our daughters, and future generations.
Thank you so much for your time.
Wishing you all the best in health.