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Should Foam-Covered Breast Implants Return to US?

Posted on Sep 28, 2012 Breast Implants

Breast implants have undergone many technological and design changes since they were first introduced in 1961. Initially, they had Dacron patches on the back that were intended to anchor the breast implant to the chest wall by allowing the body’s tissue to grow into the Dacron. These first breast implants had high rates of complication, and the Dacron was quickly ditched. In 1970, though, another innovation that was introduced: the so-called “furry” implant coated with polyurethane foam. These were designed to alleviate the risk of capsular contracture. They worked well. Polyurethane-coated breast implants have a very low risk of capsular contracture. This type of breast implant remained in use in the US until 1991 and an estimated 110,000 women received them.


Then in 1991 they were withdrawn from the US market because when polyurethane degrades, it can release 2,4- and 2,6-toluene-diisocyanate diamines (TDA), which have been shown to cause cancer in test animals. However, they have remained in use in many parts of the world, and they have even been re-approved in many countries where they were temporarily banned (Australia, for example, approved them in 2008). When polyurethane-coated breast implants were banned, there was a general concern that breast implants might be linked to breast cancer. This was initially linked with silicone breast implants, which were also banned the following year. Since silicone breast implants were re-approved for cosmetic breast augmentation in 2006, is it possibly time for polyurethane-coated implants to return?


The main benefit that polyurethane-coated implants offer is a significant decrease in the risk of capsular contracture. Capsular contracture affects 10-20% of silicone breast implant recipients in the first 8-10 years, according to the FDA’s recently-released data. However, the capsular contracture rates for polyurethane-coated silicone breast implants is much lower, 6.3% for breast reconstruction patients in a 2011 study published in the European Journal of Plastic Surgery, and only 0.4% for breast augmentation patients in a 2012 study published in the journal Aesthetic Plastic Surgery. The main fear about polyurethane-coated breast implants is the risk of breast cancer. However, no studies have documented polyurethane-related cancer in women with this type of breast implants. Studies looking for TDA in the system of women with this type of breast implant have found only tiny amounts. Based on the cancer potency for TDA, the estimate that the lifetime cancer risk for a pair of polyurethane-coated breast implants would be one in 1.1 million, according to an article in the Aesthetic Surgery Journal, published in 2006. One established disadvantage of polyurethane-coated breast implants is the appearance of a significant rash about two weeks after surgery. This rash looks terrible–the entire breasts can become red and itchy, but it passes with no further effect.


With the approval of Sientra breast implants earlier this year, the FDA is obviously open to the possibility of new breast implants on the US market. However, they may be reluctant to approve a breast implant that releases a known carcinogen. And even if the FDA would be open to releasing them, would anyone be willing to market them, with the precedent of the huge product liability lawsuit that followed the silicone breast implant ban? It’s hard to know. If you are considering breast augmentation, please contact Dr. David A. Bottger in Philadelphia today for a consultation about your options.