Silicone gel implants were taken off the market in 1992 amidst fears that they could be linked to cancer, autoimmune and connective tissue disorders (such as lupus).
But since the FDA approved their use again in 2006 many women and their surgeons have opted to use them rather than the implants filled with saline (salt water).
But are they safe? Why were they taken off the market for more than a decade and and then allowed back? Are there special rules and recommendations for their use? How long will implants last? Dr. Judith Reichman answers your questions.
What are the differences between types of implants?
There are two types of implants that have been approved as “medical devices” by the FDA:
Saline filled implants: These consist of an outer silicone shell (smooth or textured) which is either pre-filled with saline fluid or filled with saline during the actual surgery. Those that are approved come from one of two companies: Mentor and Allergan (previously known as Inamed). They were given “official” FDA approval as medical devices in May, 2000.
Silicone-gel filled implants: Made of a similar silicone based shell but pre-filled with silicone gel. The same two companies, Mentor and Allergan make them. They were approved in November, 2006.
Are there other implants available?
Yes, but they are currently not FDA approved and if a patient and surgeon decide to use them, the patient has to enroll in a clinical trail. The most talked about new type of implant is the Gummy Bear gel implants. These contain a more cohesive silicone and hence are firmer than other types of silicone implants. They are more likely to retain their original shape, but don’t feel as natural and soft.
Are there any age restrictions on breast augmentation and do they differ between saline and silicone?
Yes, saline implants should not be used for augmentation in women who are under the age of 18. The silicone implants are restricted to women at or over the age of 22. (Both are, however, allowed for breast reconstruction at any age.) The age restrictions are based on the fact that breast tissue may still be developing and changing for several years after puberty and there is a concern that augmentation will be performed before full growth has occurred. The later allowable date for silicone may have to do with the FDA’s concern about long term follow up.
Why did the FDA first rescind then give back approval for breast implants?
Implants were first introduced in 1962 and since then over 250 types have been created. The FDA only began regulating medical devices in 1976. In the 1980’s allegations that silicone gel implants could be linked to cancer, autoimmune and connective tissue disorders (such as lupus) were brought to the public’s, implant makers' and lawyers' attention. Numerous lawsuits were filed and millions of dollars were paid to settle the resultant lawsuits. The FDA requested more stringent safety data. It just wasn’t available (the way it should have been) and hence the FDA banned the general use of gel implants for augmentation, with the exception of women who required breast reconstruction subsequent to breast cancer and mastectomy. However, law suits don’t define science. The FDA revised this ban in 1993 and allowed gel breast implants to be used in controlled clinical studies for which appropriate data would be supplied. And finally 14 years after the first ban, in 2006, “core studies” by the Mentor company in which 1007 women were followed for 3 years (with MRI results 1 and 2 years after implantation) and similar studies by Allergan (601 women were followed for 4 years) were deemed sufficient; the FDA gave a qualified approval for silicone gel implant stating that women who opted to use them should be advised that:
- The implants will not last forever.
- If the implants are removed the breasts will not return to their original shape and there is a chance they will manifest dimpling, wrinkling and sagging. (In other words you may have to have reduction surgery or have new implants inserted to make them look okay.)
- When the implants are replaced there is a higher risk of complications compared to the first time.
- Mammograms are more difficult to read and may require additional views and specialized facilities for analysis.
They also required that the two companies provide on-going, follow-up of the initial women who participated in the core studies for 10 years and also provide a separate 10 year post-approval study on approximately 40,000 silicone implant patients and a control group of women with saline implants.
And finally, they recommended that the best way to screen for rupture or leaks was to undergo MRI exams starting 3 years after implantation and every 2 years thereafter.
Are the complications different for saline and silicone gel implants? And if so why would women (or surgeons) prefer the silicone type?
The silicone gel implant feels more natural than that made with saline and is associated with less dimpling of the skin. Sometimes wave-like ripples occur on the surface of the augmented breast, especially with a shift of position. Many surgeons feel this occurs more frequently with saline implants. There may also be a lower rate of capsular contraction (scarring and hardening around the implant) with gel-filled implants as compared to those filled with saline. In general, no matter what the implant is filled with, a less than perfect appearance also depends on where the implant is placed:
Submuscular placement (under the chest wall muscles): This surgical placement takes more time, may be more difficult and may initially be more painful. However it feels more natural (it’s covered up by the breast tissue). “Under the muscle implants” are also less likely to undergo capsular contracture or hardening and their placement allows for easier imaging of the breast tissue during mammogram screening.
Subglandular placement (directly under the breast tissue and above the chest muscles): The surgery may be shorter, less painful and it’s easier to “redo” if future surgery is needed. The implants and their edge or rim are, however, more easily felt and seen when placed right under the breast tissue. There is also a greater likelihood of capsular contraction. Finally, it’s harder to image the breast tissue during mammogram.
The two types of implants also come in textured or smooth shells. Some studies in the past suggested that a rough shell surface was less likely to cause severe capsular contraction but recent studies by Mentor don’t show this. Surgeons may prefer a smooth capsule implant because it can be more easily “slid into” the pocket and requires a smaller incision
All augmentation surgery can have complications which include bleeding, infection, pain and a change or lack of sensitivity of the nipples. There may be problems with future breast feeding especially if the initial incision was done around the areola (the pigmented area surrounding the nipple). The most frequent cause of re-operation or removal of implants is capsular contraction (the outer capsule scars making the implant hard, contracted and painful). The cosmetic result of any breast implant may not always be stellar—the implants may not be symmetrical, and may shift with time. As the body ages, breast tissue changes, more fat can accumulate, gravity takes over and sagging may occur, especially if the implants are large; the implants may just not look right.
A major difference between a saline implant and that made of silicone gel is the “obviousness” of an implant rupture or leak and subsequent leakage problems. If a saline implant ruptures, the fluid (which is harmless) will be absorbed by the surrounding tissue, the implant collapses and the remaining capsule can be felt as a lump in the breast. So of course, the breast will lose its shape and volume. This is certainly noticeable! But if a gel implant leaks or ruptures it may not be detectable. (The implant will not deflate.) If silicone gel implants rupture or leak, the silicone can remain within the capsule (intracapsular rupture) or it may leak out to the surrounding tissue (extracapsular) or in rare instances it can move beyond the breast (migrated gel). There are some reports of the gel migrating to the armpits, lymph nodes and even further down the arm or even to the abdomen. This can lead to nerve damage, formation of lumps and breakdown of overlying tissue and skin. There is also concern that this could cause or increase the development of connective tissue diseases, arthritis or fibromyalgia. The overall studies that examined the cause and effect of silicone gel implants with the incidence of these diseases did not prove a direct correlation, however most of the studies did not differentiate between women with intact and ruptured implants. So in the case of a rupture, the consensus is “remove and if so desired, replace!”. In some cases this can be a long and complicated surgery.
How often does rupture occur?
There is an epidemiologic disagreement on rupture rates of past silicone gel implants. Some studies have shown a general wear and tear with a “bleed” of minute amounts of gel in nearly half of the “older implants” inserted during the '60’s, '70’s and early '80’s. The shells used at that time were less durable and the silicone gel was oilier and was polymerized differently at that time. As a result, short fragments of silicone could migrate through the shell. All this has changed and rupture rates are now felt to be negligible in “primary” (first time) augmentation. The most recent data that was presented to the FDA showed the following:
Mentor rupture rates based on MRI after 3 years
0.5% for augmentation
7.7% for revision (re-do) augmentation
0.9% for primary reconstruction after mastectomy
Allergan rupture rates based on MRI and non MRI findings after 4 years
2.7% for augmentation
4% for revision augmentation
0% for primary reconstruction
Bottom line, if a woman is desirous of cosmetic breast augmentation what is your advice?
Take time and do your homework before you get the surgery. Interview reputable plastic surgeons who are certified specialists in plastic surgery. There are a number or professional organizations that list their members:
The American Society of Plastic Surgeons
The American Society of Aesthetic Plastic Surgeons
American Academy of Cosmetic Surgery
In order to qualify to use the silicone gel implants the surgeon has to have specific training and be tested by the company whose implants are being used. Find out how many augmentation procedures the surgeon performs a year, for how many years and if she or he has special certification for use of gel implants. Also inquire as to complication and re-operation rates and whether the surgery will be performed in a “proper” surgery center or hospital. Make sure you go over all the recommendations that have been instituted by the FDA and that you are comfortable with the follow-up. And know that this might not be your one and only breast surgery.
Dr. Reichman’s Bottom Line: If you still feel that your appearance and self sense of body attractiveness will benefit from augmentation, then go for it!
Dr. Judith Reichman, the TODAY show's medical contributor on women's health, has practiced obstetrics and gynecology for more than 20 years. You will find many answers to your questions in her latest book, "Slow Your Clock Down: The Complete Guide to a Healthy, Younger You," which is now available in paperback. It is published by William Morrow, a division of .
PLEASE NOTE: The information in this column should not be construed as providing specific medical advice, but rather to offer readers information to better understand their lives and health. It is not intended to provide an alternative to professional treatment or to replace the services of a physician.