My name is Meredith Kilmer from Raleigh, North Carolina, and I thank you for your attention.
I had Mentor saline textured implants for 11 years. I am a patient and a caretaker.
I implanted in 2001 and explanted in 2012.
I never received a booklet or was told that they would need to be replaced.
I was told they were safe, FDA approved, and would outlive me in my grave.
I suffered debilitating neurological and systemic symptoms, fibromyalgia, brain fog, fatigue, joint pain, skin rashes.
However, I have come to tell you about my children.
I have four kids, two born before breast implants and two children conceived while I had breast implants.
My children born before breast implants have never had pneumonia, chronic bronchitis, allergies, or morning stiffness.
My younger children struggle with the same atypical health problems that I had. When my daughter [Name] was born, her first antibiotic and antifungal was given at just 3 weeks of age. She was chronically ill, had numerous pneumonias, and skin rashes.
[Name of daughter #2] is much more symptomatic. By age 3, she had 13 antibiotics with multiple antifungals, steroids, esophageal issues, and is chronically not well. Her quality of life is a struggle. She has fibromyalgia symptoms, chronic neck and fascia stiffness, skin rashes, and she’s exhausted most of every day.
Both girls have bone and joint pain, and their pediatricians state that breast implant illness and its symptoms are not recognized in the medical journals of health disorders.
The out-of-pocket healthcare cost for myself and my daughters are substantial, and my children are not the only kids with these symptoms whose mother had breast implants.
In light of this FDA review, I reached out to women who had had children while implanted, and within the first 24 hours I received 207 written responses from mothers totaling 285 symptomatic children just like my girls.
Like me, many of these mothers have non-symptomatic healthy children born before breast implants.
FDA, I urge you to consider the five following points to ensure the health and safety of women and their children.
We need an alert system to pediatricians and a registry run by pediatricians gathering information on symptomatic children born from mothers with breast implants.
The FDA should require an updated study on the amount of cyclic siloxanes and other chemicals found in the breast milk of lactating moms and the breast implant chemicals that are affecting our babies.
It is imperative we have a study to determine the safety of breast implant chemicals and its heavy metals crossing through the placental wall and passed through breast milk.
We must have better informed consent to replace the lengthy technical manufacturers’ brochures so the patients can determine the risks are low enough to implant or not.
And we need the medical community and pediatricians to recognize that breast implants can be harmful not only to the mothers but to their precious children in utero.
Thank you.
(Applause.)
[Open public comment given by breast implant recipient Meredith Kilmer, at the General and Plastic Surgery Devices Panel, FDA White Oak Campus, Building #31, Great Room, on March 25, 2019. The title of this article does not constitute part of the speaker’s presentation to the FDA Panel, and any hyperlinks within the text or text appearing in brackets were added for clarity or ease of use by editors.]