Richard V. Dowden, M.D.
Certified by the American Board of Plastic Surgery
Cosmetic and Plastic Surgery, Inc.
6770 Mayfield Road, Suite 410
(Mayfield Heights)
Cleveland, Ohio 44124
(440) 449-7470
What is endoscopic checking of breast implants?
What is the difference between rupture and a leak?
What is the capsule around an implant?
Is having silicone in the body dangerous?
Does the silicone from a ruptured implant travel around the body?
What is "gel bleed"?
Can endoscopy tell "gel bleed" from a gel leak?
If the silicone is not dangerous, then why check for leaks?
Does endoscopic implant checking require actual surgery?
Why can't implant leaks somehow be found without surgery?
Is it necessary to look at the entire implant surface to diagnose a leak?
Is this operation new or experimental?
Can endoscopic implant checking damage the implant?
How accurate is endoscopy for detecting a leaking or ruptured implant?
How often am I supposed to get an M.R.I. for silicone gel implants?
What is the cost of endoscopic implant checking?
If an implant is found to be leaking or ruptured, then what is the next step?
Can leaking implants cause breast cancer?
When should a woman have her implants checked?
Do most plastic surgeons know how to do endoscopic implant checking?
Finding a Surgeon Near You.
Answers to Frequently Asked Questions about breast endoscopy:
Using a special magnifying instrument called an endoscope, it is possible to quickly and accurately determine whether a silicone gel breast implant has ruptured or has been leaking silicone. This test was developed several years ago by Dr. Dowden and his resident and colleague Dr. Shirley Anain, and it has proven to be by far the most accurate method available for diagnosis of implant leaks.
A ruptured implant is one in which the implant shell has totally disrupted, with all the silicone gel lying free within the scar tissue capsule. On the other hand, a leak occurs when there is a tiny pinhole or slit in the implant shell, which results in a thin coating of silicone gel all over the surface of the implant. The distinction between these two terms is not clearly understood except by plastic surgeons very familiar with silicone gel breast implants. One could roughly compare these two events to a tire blowout versus a puncture.
The term capsule refers to the thin strong scar-tissue layer that the body naturally builds around any foreign material. Every implanted medical device, such as implants, pacemakers, hip joints, heart valves, clips and sutures, becomes surrounded by this layer of scar tissue. In the case of an implant, the capsule helps to hold the implant in position, and protects it against injury. Sometimes though it can tighten, making the implant feel firmer than desired, or even hard. If an implant breaks or leaks, the capsule prevents the silicone from escaping. A minute quantity of molecules of silicone can pass through the capsule regardless of whether the implant is intact or has failed, termed gel bleed.
In the early 90's, a campaign against implants was launched by a group whose intent was to make it impossible for women to get implants of any type. Not long thereafter, several groups of lawyers realized that there was great financial potential in the issue, and contributed heavily to the media campaign. Part of that campaign involved trying to convince people that silicone made women sick, or somehow harmed their immune system. Through the years, study after study showed no connection between implants and illnesses, and that any health complaints that the implant women had were also present just as often in women who never had implants. But the attorneys refused to accept those reports, claiming that the scientists were biased, or mistaken. So the attorneys and the court appointed their own panel of scientific experts to do their own analysis and evaluation of the data, and finally settle the question. The attorneys assumed that their own hand-picked scientists would report that silicone was harmful. On December 1, 1998, that court's panel of experts made their final report: they could find absolutely no link between silicone breast implants and disease! Obviously, the attorneys are furious about their own panel's report.
Most people are surprised to learn that we all have man-made silicone in our bodies (most likely made by Dow Corning). It is located in our lymph glands, our immune systems and elsewhere. This silicone got into our immune system mostly from our drinking water, because silicone is used as a lubricant in the pipes, pumps and valves that carry our water supply. Also, we breathe in a silicone aerosol from hairsprays, perfumes, and even in the air around copier machines. Man-made silicone also enters our bodies in various medicines, and from hospital needles, IV's and syringes. None of this has ever been found to be dangerous. Moreover there are hundreds of implantable medical devices made of silicone, from pacemakers to artificial joints, and there is so far no evidence of this silicone being harmful.
This does not mean that it is absolutely impossible that some harmful effect could be found in the future, but so far none has. A comprehensive review can be downloaded from the
American Council on Science and Health site. An exceptionally clear and incisive review of the entire breast implant situation, including both the scientific and the legal aspects, is a book written by Dr. Marcia Angell, entitled "Science on Trial", published by W W Norton.
As long as the capsule is not torn or broken, only microscopic droplets of silicone can leave that capsule in the breast area. However, if that protective scar tissue layer gets torn, then a strong external force could squeeze the silicone out into the nearby tissues, causing troublesome lumps or ridges, which could be mistaken for a cancer, or could be painful. It is important to realize that microscopic amounts of silicone always do travel around the body even from intact implants, pacemakers, artificial joints, penile implants, catheters, shunts, retinal bands, and valves, with no known ill effects.
Every man-made medical device, such as hip joints, pacemakers, heart valves etc, gives off microscopic amounts of material into the surrounding tissues. These molecules then travel to the lymphnodes, the bloodstream, and are distributed to all parts of the body. This happens with silicone implants also. Studies have indicated that at most about one teaspoon of silicone leaves the implant this way in the first fifteen
years after insertion. It is not known at this time whether there is any significance to this occuring, according to the FDA. The silicone that "bleeds" in this manner is thought to be the very small size low-weight molecules, which do not remain on the surface of the implant in contact with the capsule.
It has been discovered that the silicone of "gel bleed" does not remain on the surface of the implant that is in contact with the scar tissue capsule, but apparently continues on through the capsule, leaving the surface of a non-leaking implant clean and free of endoscopically-visible silicone. If silicone gel is endoscopically visible on the external capsular surface of an implant, that is not "gel bleed", and that represents an abnormality, most likely a small hole in the implant. (Many plastic surgeons who have not had the opportunity to study the behavior of silicone gel do not understand this point.)
Normally, there is a double protection against silicone being squeezed out of the breast area, first the implant shell itself, and second the scar tissue capsule. Either one of these alone is sufficient to prevent anything more than microscopic amounts of silicone from leaving the implant area. But if the implant shell is ruptured or leaking, then one of these barriers is gone and only the capsule remains. If a severe injury were to break the scar tissue, then silicone would be squeezed into the surrounding tissues, causing lumps or ridges. For this reason, the FDA recommends that a failed implant should be removed.
Yes. It is outpatient surgery, but only requires local anesthesia. Dr Dowden takes about ten minutes to check each implant. A single stitch is all that is needed to close the tiny incision. The patient does not stay overnight, and can resume activities the next day.
Doctors have been searching for many years for reliable, accurate ways to check implants without surgery. Doctors cannot tell by examination that a gel implant is not leaking. There are several tests that are very helpful, but none are as accurate as endoscopic checking for leaking implants. Completely ruptured implants are often detectable with mammograms, ultrasound, or magnetic resonance MRI, but very small leaks of silicone do not reliably show up on any of these studies. The most promising for the future may be MRI, but sufficient accuracy for MRI seems years away. That is why Dr. Dowden and Dr. Anain developed implant endoscopy.
No, it is not necessary to look at the entire implant surface to diagnose a leak. This is due to the behavior of silicone, which very rapidly coats the entire outer surface of the implant with a thin layer of silicone gel from even a tiny leak point. Under the high magnification of the endoscope (a factor of 100) the very thin layer of silicone gel is easily detectable. Therefore, a view of any point on the implant surface in contact with the capsule will indicate whether there has been a leak anywhere on the implant. (Some plastic surgeons have not acquired an understanding of this principle of silicone gel behavior.)
Neither new nor experimental, its development was started in 1987. It has proven over the years to be by far the most accurate way to determine whether implants have ruptured or have tiny leaks of silicone gel. The technique requires specialized training and special instruments in order to perform correctly, and a number of plastic surgeons across the country have been trained to do this procedure.
No. The development of the technique, accurate as well as safe for implants, took several years of laboratory testing. In this technique, the endoscopic instruments never touch the implant. In both clinical and laboratory settings, the endoscopic technique has not damaged any implants, and is not expected to, if it is done by a properly trained plastic surgeon using the technique as it was developed and taught by Dr Dowden and Dr. Shirley Anain.
Because the endoscope is looking directly at the implant, and because it has such high magnification, it has so far been completely accurate when performed using the technique as Dr Dowden and Dr Anain teach it.
The FDA advises an M.R.I. be done every 2 years. These cost about $1500 and are at the patients own expense. Here is the wording in the silicone gel implant brochure giving the instructions to the surgeon on warning the patient:
You should advise your patient that she will need to have regular MRI's over her lifetime to screen for silent rupture, even if she is having no problems. The first MRI should be performed at 3 years postoperatively, then every 2 years thereafter. Such diagnostic procedures will add to the cost of having silicone breast implants and patients should be told that these costs may exceed the cost of their initial surgery over their lifetime.
The cost of endoscopic detection of breast implant leaks is about $1500, everything included.
The surgery is prepaid, but various financing options are available. Because the endoscopic method is much less expensive than the older surgical methods of evaluating implants,
(and less expensive than MRI, which is not as accurate), most of the health
insurance companies have generally considered at least a portion of the costs coverable.
That depends entirely upon what the patient wants to have done. The various alternatives are always discussed between the patient and Dr Dowden in advance. Some women prefer to procede directly with removal and replacement of the implant with a new one (either switching to a saline-filled implant or having a new silicone-gel implant placed), while other women prefer to first get the diagnosis and then to decide thereafter how to procede.
There has never been any evidence of a breast cancer having been caused by a breast implant, either silicone or saline-filled. In fact, recent studies have shown that breast cancer is less frequent in patients with implants than in patients without implants. This does not mean that women with breast implants can disregard the need to self-examine or get mammograms done.
A woman who has had a severe injury to the breast implant area, or who has noted a significant change in the feel or consistency of the breast, will need to consult with a plastic surgeon for evaluation, and will probably need to have the implants checked endoscopically. If a mammogram, ultrasound, or magnetic MRI has a suspicious appearance, the implants should be checked. Dr Dowden is advising that women should have their silicone-gel filled implants checked between ten and fifteen years after being inserted.
No, only a few plastic surgeons around the world have been trained to perform the technique of endoscopic implant inspection. Most plastic surgeons do not have training or experience in the procedure, and in fact some plastic surgeons have not had reason to acquire an understanding of the principles of silicone gel behavior upon which the test is based.
If you are interested in breast implant inspection and want to find a board-certified Plastic Surgeon in your area who is qualified to do it, call the referral service of the American Society of Plastic and Reconstructive
Surgeons at (800)-635-0635, or check http://www.plasticsurgery.org. Alternatively, one can ask the local plastic surgery society, or the plastic surgery department of the nearest medical school.
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Note that while the information given by Dr. Dowden during a consultation is completely current and up-to-date, the information of this website is only as current as the date of last update, and therefore may become out-of-date.
Cosmetic and Plastic Surgery
6770 Mayfield Road, Suite 410
(Mayfield Heights) Cleveland, Ohio 44124
(440) 449-7470
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Last Update: 6:45 PM on 06/01/2008
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