need to know more about the safety and whether doctors now recommend getting silicone breast implants
Silicone Breast Implants Safe?
Doctor Answers 80
Silicone breast implants are SAFE! A detailed history.
Breast implants were developed and utilized for more than a decade before the FDA began regulating medical devices in 1976; the safe and effective use of silicone in these and other medical products such as pacemaker insulation, lubrication for insulin needles, chemotherapy tubing, and artificial joints was well-established before the FDA could evaluate all of them. Because silicone breast implants and many other silicone medical devices were already in use prior to 1976, the ongoing use of these products was “grandfathered” by the FDA without formal evaluation and approval. None of these other silicone medical devices has been made unavailable to patients, but lack of formal FDA evaluation and approval of breast implants came into public awareness in the early 1990s.
The lay media has been responsible for spreading a great deal of information and misinformation regarding breast enlargement in the past two decades. Many women remember tabloid and TV talk shows' focus on the supposed problems claimed to be associated with silicone gel implants. Despite a lack of scientific data supporting these concerns, in 1992 the FDA restricted the use of silicone gel breast implants in women requesting elective breast augmentation.
At no point have silicone gel implants ever been “taken off the market,” but until November 2006 their use required enrollment in the FDA study that allowed only eligible patients and plastic surgeons access to them under strict guidelines. Since the FDA restrictions in 1992, numerous peer-reviewed scientific studies (over 30 in the past decade) have continued to show NO cause-and-effect relationship between silicone gel breast implants and autoimmune-type illnesses (such as rheumatoid arthritis, lupus, scleroderma, or so-called "human adjuvant" diseases). Since 1992, silicone gel implants have been used by plastic surgeons (including myself) involved in FDA-approved studies for patients undergoing breast reconstruction, breast augmentation revision (in certain patients), breast lift, and for those patients with congenital breast deformities.
After exhaustive review of the past nearly four decades of use, the FDA approved the use of saline-filled implants in May 2000.
Late in 2003, the FDA reviewed all of the available scientific data about silicone gel implants, including very detailed information from implant patients over the past decade, and heard testimony from patients, physicians, and researchers. The expert physician advisory panel to the FDA voted to recommend that the FDA approve the use of silicone breast implants for primary elective breast augmentation. However, the FDA deferred its decision, requesting “additional information” before granting approval.
In spring 2005, the FDA again revisited the request by both of the existing implant manufacturers for approval of general use of silicone gel implants; the expert physician advisory panel recommended approval for Mentor Corporation’s gel implants. Late in 2005, Both Mentor and INAMED® (now Allergan) received letters of “[gel implant] product approvable” from the FDA.
On November 17, 2006 the FDA approved the use of silicone gel implants from both companies in patients over the age of 22, with certain restrictions, including involvement in the FDA study that has been ongoing for the past several years.
Opponents of silicone gel implants continue to claim that they cause autoimmune illness or are unsafe, but peer-reviewed scientific studies by many researchers and institutions have shown them to be safe and effective for their intended use. The controversy about silicone gel implants has made them one of the most intensely studied products in the entire medical marketplace.
As part of the 2006 FDA re-approval of silicone gel implant use, each company has an informed consent booklet that you will be asked to read (and sign). The FDA has made a controversial recommendation that patients with silicone gel implants undergo a MRI (magnetic resonance imaging, a non-X-ray study similar to a CAT scan) every two to three years to evaluate their implants (for leakage or rupture). Studies have shown that MRI evaluation of silicone implants has 79% effectiveness in detecting implant rupture or “leak.” Thus, if you have no identifiable problem or concern with your implants and choose to follow this recommendation, you will require an unnecessary re-operation (for entirely normal non-ruptured) implants 21% of the time! The FDA makes this recommendation because physician examination has been shown to be unreliable in detecting silicone implant rupture. Yet, since present silicone implants are cohesive and cannot “leak,” this is a nonsensical recommendation, in my opinion.
If you are not having any kind of problem or concern with your implants, it is ridiculous to perform a costly (may not be covered by your insurance) and often-inaccurate test that would require an operation (erroneously) over 20% of the time. Rather, I believe that if you have any issue at all with your implants (size, shape, position, firmness, or concern about possible rupture), return to your surgeon for evaluation. He or she can then do whatever corrective surgery is needed, where they will be able to examine, and replace if necessary, the implants under direct vision. Your surgeon can offer better than 79% accuracy with direct implant examination!
Since 2006, over 99% of my patients choose the newest cohesive silicone gel implants! Best wishes! Dr. Tholen
Silicone Breast Implants Manufactured in America Are Safe
Thank you for your question.
Many years of development and FDA approved studies have produced a modern cohesive Silicone Gel Implant with a non bleeding shell which are safe and FDA approved.
The problems with older Silicone Gel Implants such as silicone bleed and gel migration after rupture have been corrected with the new implants.
However the same safety guidelines and controls have not been imposed on manufacturers in other countries- eg. the recent disastrous problems with the PIP Breast Implants in Europe.
Buy American and only see a Plastic Surgeon Certified by The American Board of Plastic Surgery.
Are silicone breast implants safe?
These are the main points to remember in regards to Silicone breast implants:
- Based on numerous scientific studies, silicone breast implants have been shown to be safe and effective.
- Even if the breast implant shell is ruptured, they don't leak and travel through the body.
- Using MRI, we can detect any leakage and remove the implant without difficulty.
Hope this is helpful.
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Breast Implants and Augmentation Safety
Silicone gel breast implants were first developed in 1961. Because of some concerns in the 1980s about a correlation of silicone gel with some medical problems, silicone implants were removed from the market in 1993. This was done, unfortunately, before significant studies were performed to prove or disprove any of the allocations against silicone.
These studies were subsequently performed, however, and in these major studies, no significant correlation has been found between silicone breast implants and the connective tissue disorders that were of concern years ago. For this reason, silicone gel breast implants were returned for public use with an endorsement by the Food and Drug Administration in 2006.
Silicone gel breast implants have the advantage of a smoother, more natural feel than their saline filled counterparts. Like the saline breast implants, the outer coating of the silicone breast implants are made of a silicone shell. These implants come pre-filled, and therefore must be placed into the appropriate pocket behind the breast through a slightly larger incision. Once in place, however, silicone implants are thought to show less rippling and have a more natural overall feel to them.
Silicone breast implants are often recommended for women who have very little breast tissue preoperatively, when they will be easily felt through the overlying skin and small amount of breast tissue.
Like any device in medicine or, in fact, life for that matter, breast implants can fail after a period of time. This may be in the form of a rupture of the outer shell of the implant, causing the saline or silicone to leak out. With saline breast implants, the saline is absorbed by your body without a problem, and your affected breast becomes “deflated” or smaller again. With silicone gel implants, however, your body does not absorb the leaking silicone in the same way, and therefore there may not be any outward signs of any problem.
Because of this, the FDA has recommended that patients who have silicone breast implants are checked with magnetic resonance imaging (MRI) periodically to make sure that there are no problems with their implants. In the case of rupture of either a saline or silicone breast implant, replacement is indicated and can be easily performed by your plastic surgeon.
Silicone implants are safe
I have no hesitation in recommending silicone implants. We have so many studies and years of experience in the use of these implants, that we know they are safe from a medical point of view. The majority of my patients desiring breast augmentation are currently asking for silicone gel implants. The rate of leakage is acceptably low so far, and with regular monitoring with an MRI, you can know the status of your implants. The softness and natural feel of gel implants is better than saline for most women which is why they choose them.
The FDA says silicone implants are safe and effective
The issue of the safety of silicone breast implants was settled in 2006 when the US FDA pronounced that after 14 years of research they had concluded that silicone does not cause any dieases and does not have side effects. Now, nearly six years later more women are choosing to have silicone impants than saline implants. Natioanlly this figure is 60% and in my own practice it is closer to 100%.
The only people with detectable high silicone levels in their body are long term insulin dependant diabetics. They have been giving themselves shots with syringes that are lubricated with silicone. After decades of shots there is enough silicone that went down the the syringe and into their bodies with the insulin that it can be measured. But guess what? None of these diabetics have any diseases or side effects from the silicone that has accumulated over the years.
The latest implants have hgihly cohesive gel inside them. it is much more like jello, and when they are cut open nothing spills out or runs out. So in the unlikely event that the outer shell breaks open what is inside can't be absorbed into the breast or the body.
So the best way to figure out if you should get saline or silicone is to feel both of them side by side and decide which one is softer. if you are still freaked out about the word silicone and couldn't sleep at night because you think there is something toxic in your body you should choose a saline implant. But if you like the softness of the silicone and you can trust your surgeon that the FDA says it is safe and effective then it can be the right implant for you.
Silicone Implants Are Considered a Safe Choice for Breast Augmentation
No medical device has been studied more than silicone implants.
After review of years of many hundreds of intensive laboratory and clinical studies, the Academy of Medicine concluded there was no evidence that women were becoming ill from silicone gel implants.
The FDA agreed with this conclusion and approved the use of silicone gel-filled implants for cosmetic breast augmentation.
Because of their natural feel, silicone gel-filled implants have again become the most popular choice for women having breast augmentation.
As with any important medical decision, discuss your options with a doctor you trust to help you make the best choice for you.
Silicone Breast Implant Safety
Best place to start is your particular definition of "safe".
1) Anesthesia/Procedure : Breast Augmentation, one of the most popular aesthetic plasctic surgery procedures performed by Board Certified Plastic Surgeons on female pateints desireing breast enhancement, is a tremedously SAFE procedure as long as it is performed in a certified Hospital or out-patient surgery center.
2) Implant composition : You know the answer to this. The previous surgeons on this thread as well as the internet information you probably already have, demonstrate the evidence governing the FDA recommedations on Silicone breast prostheses and there placement. My spin to patients on this information, is this, all surgically implanted prostheses (artificial knee/ hip joints, heart valves, BREAST IMPLANTS) are foreign bodies that the body, over time, will form scar tissue around and the device itself will go on to eventually fail (rupture).
3) Disease : Breast cancer is the big issue here. Many reports have been written, but all in all, evidence does suggest that breast implants do not cause breast cancer nor do they case systemic diseases like rheumatoid arthritis, lupus, etc. Actually, there is also outcomes evidence that patients with breast impants have a lower incidence of breast cancer.
Therefore, I hope this helps answer a couple of variations of the "safety" question.
I really suggest that you speak with a Board Certified Plastic Surgeon in your area (www.plasticsurgery.org). They will be able to address the above issues as well as answer all your great questions!
Silicone implants safe, if you trust FDA
There are two types of breast implants available: saline and silicone. Saline implants are made of a salt-water solution whereas silicone implants are made of a silicon gel. The latter have come under much scrutiny in the U.S. during the early '80s.
The Food and Drug Administration removed silicone implants from the market after numerous women were complaining of odd symptoms. During that period they could only be used for reconstructive purposes. The problem developed from the lack of studies done on the implants in the first place. Therefore a team of doctors and government agencies such as FDA began doing research into improving the implants.
I personally took part in this research and after numerous government hearings the implants were re-approved by the FDA over two years ago. Some restrictions still remain, for instance the patient must be at least 22 years old (whereas with saline, women as young as 18 years old can get implants).
Also it is recommended, that the implants should be examined by MRI studies every five to 10 years to check for leaking. To avoid problems with breaking or leaking, the shells of silicone implants have been made thicker than original ones. Also, now the gel is more like a gummy-bear-type of product tather than pure liquid, which should prevent the silicone from leaking into the body.
Since this re-approval, silicone has come back in favor. Eighty percent of breast implants used in my practice today are silicone. Silicone implants have a softer, more natural feel and look. However, about 20% of my patients still want the piece of mind of just having salt-water in their implants. Saline still has a 98 percent satisfaction rate.
Silicone Breast Implants Cohesive Gel Implant Information
The silicone gel breast implants that we use today are filled with cohesive gel material, which is in a solid rather than liquid state. It's still a silicone gel product, and it still feels soft and breast-like, but it does not ooze out of the implant if the outer shell fails. If you cut a cohesive silicone gel implant in half, you end up with two halves of a solid implant, rather than a sticky, gooey mess. The outer shell material and design has also been improved, making the implants more durable and failure rates lower. The FDA took all of this into account, and gave cohesive gel implants a 'green light' for cosmetic breast augmentation in 2006.
Because the gel is in a solid state, cohesive gel implants feel somewhat firmer than liquid gel implants - but only a little firmer. I think that this is actually a positive change, as in my experience liquid gel implants simulate a soft, more mature breast (which is more fatty and less fibrous, typical of the natural breast at age 40 and over), while cohesive implants simulate a firmer, more youthful breast (which is more fibrous and less fatty, typical of natural breasts at age 20-30). Many of my patients who are moms in their forties relate that the cohesive silicone gel breast implants make their breasts feel more like they did before they were pregnant, which is an enhancement that they enjoy a great deal.
In the time since the moratorium was lifted, gel implants have gone from being used in my practice on rare occasion to being used in almost all the breast augmentations I perform. Patient satisfaction has been excellent and I have been very pleased with the performance of the new ‘cohesive’ gel material.
One distinct advantage of gel implants is the fact that in almost all cases the edges and anterior surface of the implant are not palpable, and it is thus very difficult to detect by touch or feel that an implant is present. In many cases it is actually impossible to detect the implant at all. This makes gel implants a very attractive option for women who are quite slender and have a small natural breast volume, as saline implants are usually very easily detected by touch or feel in these patients.
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.