Silicone breast implants: Are they safe?

Dr. Judith Reichman TODAY contributor • Profile • E-mail

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.

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