My name is Robyn Towt. I am a breast cancer survivor. I was diagnosed in 2017 and I had a double mastectomy and reconstruction with Mentor Silicone breast Implants. I did not have chemotherapy or radiation treatment, nor did I take hormone therapy drugs, I only did surgery. I was feeling just fine until the implants were put into my body, they made me horribly ill. I’ve had three cancers in my life of 46 years and having breast implants were worse than all three cancers put together. I suffered the entire time that I had them in with the following symptoms:
headaches/migraines, heart palpitations, difficulty breathing, difficulty swallowing, skin rashes, hair loss, joint pain, extreme fatigue, physical therapy 3 times a week, anxiety, choking feeling, chest pain, burning pain, red eyes, chronic inflammation, dizzy/lightheaded, insomnia
I went back to my surgeon 4 times and she said it wasn’t from my implants, and that my implants are safe. I also wasn’t given the patient information brochure prior to getting my implants. ALL of the health issues that I was experiencing are outlined in that booklet. If I had that booklet, I would have been able to determine the cause of my failing health much sooner.
Another breast cancer lady shared with me how her implants made her sick, leaving her bedridden and unable to work. Her story resonated with me and sounded remarkably similar to mine. So I removed them after just 4 months and every single symptom has resolved. I then became a member and administrator of the FB group Breast Implant Illness and Healing by Nicole.
Over 75,000 women in our group have had a similar experience. In a recent survey of over 2,300 women, 83% said they were not given the patient information brochure, 83% said they did not feel they understood all the risks at the time, and 97% said they weren’t given enough time to make an informed decision. This is not acceptable.
I work closely with the AZ Society of plastic surgeons. The four board members of that society told me that they don’t give the booklet to every patient because they only get a couple of booklets in each shipment of breast implants. I also contacted
a mentor rep who confirmed that only a few booklets are given with each shipment, but the surgeons can request more and they will be provided. Part of the premarket approval agreement between the breast implant manufacturers and the FDA in 2006 was that EVERY single patient was to get that patient information booklet.
None of this information is new. The FDA has been hearing all of this…FOR DECADES. These same stories of sick women pleading for help. Women are not being properly informed and breast implant manufacturers are not being held accountable. Something needs to be done to remedy this situation. It is very difficult to be optimistic about solving this problem when the SYSTEM has COMPLETELY FAILED us for DECADES.
SOMETHING needs to change, this is a global women’s health crisis.
In March 2019, the FDA released that the implant manufacturers have clearly violated the conditions of their PMA. I implore the FDA to revoke the premarket approval that was given to the breast implant manufacturers in 2006. There should be consequences for these violations, otherwise the safety studies will never be completed and women will continue to suffer.
In the meantime, in order to protect women and give them proper information to make an informed medical decision, I am suggesting implementing the following…for FULLY INFORMED CONSENT.
- Mandatory Patient Information booklet
- Mandatory Patient/Doctor Checklist (see attached)
- Mandatory Chemical Ingredient list
- Black box Warning Statement including ALCL and autoimmune
- Mandatory testing explant patients for ALCL at implant manufacturers expense
- Continuing education for surgeons on how to properly remove implants
- NBIR to include explant patients retrospectively, following and monitoring symptoms pre and post explant.
- Health Care Provider Letter to physicians, clinicians and surgeons stating that breast implants cause autoimmune diseases
- IMMEDIATE BAN AND RECALL of all textured breast implants
- Funding for awareness of Breast Implant Illness and ALCL
For the breast implant manufacturers I suggest…
- Compensation and reimbursement for explants of theTHOUSANDS of women who have suffered autoimmune and health issues and CANCER from implants that were deemed “safe”. The manufacturers need to be held accountable.
Robyn testified before the FDA Advisory Committee on breast implants in March 2019.