Sonia Pressman Fuentes on Breast Implant Ruptures and Leaks
Sonia Pressman Fuentes, co-founder of NOW and civil rights lawyer, has given us the benefit of her expertise about laws affecting women's employment several times. Now she brings to your attention an issue that we or our friends may be contending with: breast implant leakage or rupture. Time to get informed! LH
Millions of women in the U.S. have breast implants, which they secured after mastectomies or for cosmetic reasons. Many of them do not know (1) that they need periodic MRIs to determine if their silicone gel-filled implants are leaking or have ruptured; (2) how to find a facility that has the equipment for performing such MRIs; and (3) what to do if the MRI reveals their implant is leaking or has ruptured.
I had no problems with the silicone gel-filled breast implant in my right breast during the fifteen years after my 1990 mastectomy and simultaneous implant at a major hospital in Washington, D.C., other than its hardening. During those fifteen years, none of the doctors I saw in Washington, D.C. (the surgeon who performed the mastectomy, the plastic surgeon who did the implant, my oncologist, or my internist) ever suggested that (a) I have a test to determine whether the implant had ruptured or was leaking, and (b) if a rupture or leak were found, I consider having the implant removed and replaced.
In the spring of 2005, while I was at my Sarasota, FL, winter residence, I began to notice that my right breast appeared to be growing smaller. Shortly thereafter, I saw an article on CNN.com stating that silicone gel-filled implants had limited life spans and could leak or rupture and advising women to have periodic MRIs to check on their implants.
When I returned to my Potomac, MD, residence in late spring, I researched this matter on the websites of the FDA and the National Research Center for Women & Families (NRC), visited my oncologist and plastic surgeon, and discussed this matter with the surgeon who performed my mastectomy.
I learned from my research that studies by Dr. Lori Brown and her colleagues at FDA indicated that most women with silicone gel-filled breast implants would have at least one broken implant within ten years.
The FDA's website at that time stated:
"Breast implants do not last a lifetime. Some breast implants rupture/deflate in the first few months after being implanted and some deflate after several years. Others may take 10 or more years to rupture/deflate . . . .
"As a last note, FDA does not consider mammograms an adequate means of detecting implant rupture/deflation for silicone gel-filled breast implants. As described in the Local Complications & Reoperations (Rupture/Deflation of Silicone Gel-Filled Breast Implants) section above, FDA believes that MRI is currently the best method for detecting implant rupture for silicone gel-filled breast implants."
When I mentioned these facts to my doctors, they either expressed ignorance of this information, suggested I have a mammogram before an MRI to check on the condition of the implant, or said that even if the implant were found to be leaking or had ruptured, removal and replacement were not necessarily required as such leaks and ruptures were not harmful and that the decisions as to whether to remove and replace a leaking or ruptured implant were up to me.
On the issue of whether silicone gel-filled breast implants that are leaking or ruptured should be removed, NRC's website then stated as follows:
"Can broken implants make me sick?
"According to the FDA's research, women with leaking silicone implants are more likely to report fibromyalgia (a painful disorder) or several other painful and debilitating diseases. . . .
"What do I do if my implant breaks?
"Most experts agree that it is important to remove a ruptured implant as soon as possible, especially if it contains silicone gel . . . .
"It is important to have ruptured silicone gel implants removed as soon as possible. The longer the silicone is allowed to remain in the body, the more time it has to migrate to other parts of your body, like lungs or lymph nodes, where it can't be removed. Unfortunately, nobody knows for sure what will happen as a result of silicone in the body because no one has conducted any research on the subject."
(The National Research Center has an excellent July 2009 article, entitled "What You Need To Know About Breast Implants" by Dr. Diana Zuckerman, president of the Center; Elizabeth Nagelin-Anderson; and Elizabeth Santore on its website at http://www.center4research.org/2010/04/what-you-need-to-know-about-breast-implants/. This subject is also discussed on websites called breastimplantinfo.org at http://www.breastimplantinfo.org/what_know/if_implant_breaks.html and the Stop Cancer Prevention and Treatment Fund at http://www.stopcancerfund.org/posts/511.)
I was able to get a prescription for an MRI from one of my doctors and then I had to find a facility qualified to perform such an MRI.
In my research, I learned that Dr. Michael S. Middleton, a diagnostic radiologist in San Diego, California, was an expert on using MRIs to detect the leaking and rupture of silicone breast implants. Dr. Middleton suggested I find a facility that:
a) had a 1.5 tesla scanner,
b) had and used a "breast coil,"
c) imaged each breast independently (one at a time),
d) for each breast, performed T2-weighted imaging with water suppression, and then with silicone suppression*, and,
e) for each sequence, obtained images at high enough resolution: minimum: 20 cm FOV, 256 x 256 matrix, 4 mm slice thickness.
I called two facilities in the Washington, D.C., area that did not have this equipment but then I found one that did and scheduled an MRI for June 1.
Subsequently, I had the MRI, which showed that my implant had indeed ruptured.
Thereafter, I consulted several experts for recommendations on a surgeon to remove and replace the implant. All highly recommended Dr. Lu-Jean Feng of Cleveland, Ohio. At the end of August 2005, I flew to Cleveland to consult Dr. Feng, who recommended that I have an ultrasound given by a doctor in Cleveland who specialized in such ultrasounds. That ultrasound confirmed the diagnosis that the implant had ruptured. On September 1, in the Lu-Jean Feng Clinic, Dr. Feng removed the ruptured implant and replaced it with a saline implant.
That was five years ago and so far, so good.
With regard to the rupture of a silicone gel-filled breast implant, it is a different story. It is likely that neither the woman nor her doctor will know. This is known as a silent rupture. The FDA recommends an MRI at three years after implantation and then every two years thereafter to screen for such ruptures. (http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/breastimplants/ucm063719.htm)
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*By e-mail of May 13, 2009, Dr. Middleton wrote me: "For saline rupture, in particular, it is very rare that MRI is needed to tell whether deflation has occurred. It is usually an all-or-none event - either it is deflated or it is not, and that would probably be evident without an MRI."
Copyright 2011 by Sonia Pressman Fuentes
I had mold growing in my implants. I have the moldy implants to prove it, but I had complained for years of breast pain. I was sent for mammograms for years. I had strange illnesses. All my mammo written reports said normal, until one ruptured 3 days prior to a scheduled mammo after i complained of the pain and engorgement again. At the mammo the tech says "yep, it ruptured, but we saw that leak 2 yrs ago". WHAT???? I said, and went to get my mammos films to view and I can see the mold growing in the right implant for years. Had that tech not said that to me, I still would not know what was making me so sick and baffleing 16-18 different doctors. Do you know of any attorneys that would help me? the ones I have spoken too make this so hard that can not see the simpleness of radiologist and that medical center failed me. Please help if you can~!~ Anne 850-543-0390.
Dear Melissa:
I'm a lawyer, not a doctor, but if your aunt has had pain, she needs to see a doctor or doctors and find out what is causing it. I never had pain with either of my breast implants so far. She could have a problem caused by the leaking of silicone into her system, lupus (I don't know if that causes pain but it has been alleged to be related to breast implants), or some other medical problem.
Pain has nothing to do with normal aging.
Best,
Sonia
My aunt had this problem and, similarly to Sonia, got the real run-around from her doctors for a while. But finally (thanks to the internet again) she convinced them to check and she did have a leak. They took it out and replaced it but she still has a lot of pain. I am not sure if its just normal aging in her case, but she hoped for a lot bigger effect than she got from the removal.
Sonia, it is really great that you were willing to tell us your personal experience with this issue. It makes your recommendations very persuasive. I hope all the readers take it to heart!
cheers,
Laura
Thanks for the update, Sonia. This is exactly the sort of question people ask scientists, hoping for an informed answer. Now I'll be able to give a good answer, thanks to you. FBP
I am delighted to see Diana Zuckerman's approbation. That is high praise indeed. She is Diana Zuckerman, Ph.D.
President
National Research Center for Women & Families
Cancer Prevention and Treatment Fund
1001 Connnecticut Ave., NW, Suite 1100
Washington, DC 20036
202 223-4000
www.center4research.org
www.stopcancerfund.org
Diana is "the" person who steered me in the right direction when I thought my implant might have ruptured.
Sonia, Thanks for this excellent article. Every week, our Center hears from women whose silicone gel implants have been leaking for years, but they either didn't realize it or their plastic surgeons told them it didn't matter. Many of them suffer from pain or other symptoms that they thought were from aging. But when their leaking implants are removed -- if the leaking silicone is also carefully removed -- many feel better than they have in years. You might be interested in an article I published in Reproductive Health Matters last year on informed consent regarding breast implants: http://www.breastimplantinfo.org/news/implants-informed-consent.html
Yes, and the idea that most people with implants will have a problem with them within 10 years means there's a ticking time bomb out there; women do need to get informed about this issue. Tell your friends!
cheers,
Laura
Wow, I had no idea that you could have leakage or rupture and not know it. Time to check with the doctors!
