Article- Silicone Breast Implants are Safe, But Not Forever

Aug 13, 2011 by

Once again another article with good news and bad news. The good new from this article posted by the ASAPS is that the FDA has evaluated studies regarding silicone breast implants and determined they do not cause cancer, reproductive problems and a number of other issues. The good news from the article:

The best news from the FDA is, “Studies to date do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems, or connective tissue disease, such as rheumatoid arthritis.” But the FDA also states that no study has been large enough or long enough to completely rule out these and other rare complications. 

The biggest worry about silicone implants has been their association with a rare type of breast lymphoma. But now, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Heath, calls this possibility “profoundly small.”

And, here is the bad news that once again leaves the Furry Brazilian disappointed, upset and frustrated:

If you’re considering breast enhancement, bone up on the new FDA information about silicone breast implants. For women in their 20s and 30s, when most women get breast implants, and for other women as well, this is what you need to know: breast implants are not lifetime devices. Like your car or vacuum cleaner, your silicone breast implants will not last forever; they may need removal or replacement within a decade. It’s not like they’re designed for extinction, it’s just that they’re placed in a living organism, you, and subject to the whims of nature.

Of those who choose silicone implants for cosmetic purposes, 20 to 40 percent will have problems leading to removal or remodeling. Of those who get implants following mastectomy, chances of needing implant removal are even greater; 40 to 70 percent of breast cancer patients need implant removal or revision. For both groups, this is the maintenance plan: the FDA recommends that you get an MRI every two years to screen for “silent ruptures” in your implants. Unlike saline implants, which deflate when they tear, silicone implants do not deflate, so imaging is necessary to ensure that your implants are intact.

Capsular contracture, which is shrinkage of the space containing the implant, is the most frequent problem leading to reoperation. Other implant problems are rupture, wrinkling, asymmetry, scarring, pain and infection. This is not an appetizing list, but at least these problems are “local,” not systemic, and can be dealt with surgically. 

So, here I sit, evaluating studies and reports that show Polyurethane breast implants have a lower rate of capsular contracture, wrinkling, rotation and malposition, but they are not approved in the USA. But wait, they are approved in over 35 other countries, so they must be safe.

The numbers listed in the article- removal of 20-40% due to problems- are not acceptable.

Remember- for years (over 20?) silicone breast implants were not approved in the USA but were used all over the world- and used safely with high patient satisfaction rates. Now the FDA is saying silicone breast implants are safe- what the rest of the world has known for years. Should we be looking to the FDA for safety guidance for Polyurethane implants? Or looking to what many other countries in the world say?

The FDA continues to say  capsular contracture is the leading cause for reoperation following breast implant surgery and that implants are not for life; yet the FDA, unlike the 35 other countries, is not studying or approving the implant with the lowest documented rate of capsular contracture: polyurethane foam covered silicone gel breast implants.

The entire article:



Leave a Reply

Your email address will not be published. Required fields are marked *