Ten years ago, I made a decision to follow up my mastectomies with silicone breast implants. I was making my decision “back in the day” when insurance companies would pay for several opinions and more than one consultation. I remember meeting with my plastic surgeon THREE times regarding my implant choice. I went with silicone - bad choice. They had to be removed in less than a year when I began to develop many strange symptoms (one of which was hair loss). After two years of wearing prostheses, I re-integrated breast implants into my body and life with a pair of saline implants. We have peacefully co-inhabited my body ever since until - wham - last week’s news…
Call it Lymphoma, call it Anaplastic Large Cell Lymphoma (ALCL), call it breast cancer or whatever, if it’s in the kingdom of Cancer, and I raised my risk by making the already difficult decision to surgically reduce my risk, this is, on the surface, shattering news.
But wait. Never fear - the FDA is here - to protect. The FDA is encouraging nurses to assure their patients that FDA-approved breast implants are safe and effective “when used as labeled.” Now let’s not get into those pesky reality details, like WHO the FDA is most effective at protecting (Allergen and Johnson & Johnson, Inc vs. you and me).
So the FDA reportedly reviewed 13 years of data published in the scientific literature, confirming 34 unique cases of ALCL in women with breast implants through-out the world. Stop there.
Are we to assume that in all countries where breast implants are common, they actually report ALCL in the scientific literature? Maybe they do, but I am doubtful. Just as I doubt that my doctor reported the symptoms I had following my silicone implants (even though I requested that he report them to the company). In some countries, like Colombia or Venezuela, breast implants are both very affordable and very common, I’m talking even among 16-year-olds. Are they tracking ALCL rates in all those recipients, and is it published in scientific literature that the FDA can access? I’m doubtin’ it. Nonetheless, contact with the world’s regulatory agencies leads the FDA to estimate 60 such cases worldwide. Not such a frightening number, to be sure.
On the other hand, a risk factor is just a… well, risk factor. The American Cancer Society reassures us, “Having a risk factor, or even several, does not mean that you will get the disease.” I guess that’s why they focus on “the cure” and not “the causes”.
The FDA is drawing attention to the potential breast implant-ALCL connection because in those documented cases, ALCL seems to have developed in the scar tissue that resulted from the implant procedure.
I wonder if the FDA has ever heard of “capsular contracture“. My sisters and I know it well. And our implants were “used as labeled”. According to breastimplants4you, we are among the 5 percent of women who get implants and who develop capsular contracture. This is when excessive scar tissue forms around the breast implant, causing the implant to harden as the naturally-forming scar tissue around the breast implant tightens and squeezes it. Every patient is expected to have some scar tissue around the implant - too much of it crowds and squeezes the actual implant. Symptoms of capsular contracture include pain, swelling, and increasing firmness of the implants.
The FDA lists the following symptoms as those associated with increased risk of ALCL following breast implant surgery - pain, lumps and swelling. If that sounds familiar, it’s because you just read about these same symptoms in my above paragraph about capsular contracture. The FDA states that “most of these cases have occurred in patients undergoing implant revision operations for late-onset, persistent sernoma. “ Someone here seems to be underestimating the prevalence of this condition, or at least the symptoms. Could it possibly be breastimpants4you, whose most likely objective is to reassure potential customers? Or is it the FDA, who estimates a total of 60 breast implant-related cases of ALCL worldwide, or an estimated 1 in 83,333 who get breast implants?
I’m not one to panic over the latest speculative medical news. But I’m also not one to completely trust the FDA to protect my health. This is one of many unraveling medical stories I’ll be following. How are you reading this news? Have you or anyone you know experienced capsular contracture following your breast implants?
Susan Beausang
President, 4women.com