One-Third of PIP Silicone Breast Implants May Rupture: Study

Recent research suggests that as many as one-in-three silicone breast implants made by Poly Implant Prothése (PIP) may rupture, if they have not ruptured already. 

In a study published last month in the Journal of Plastic, Reconstructive and Aesthetic Surgery, researchers looked at data on 453 patients who received PIP breast implants, in the wake of the company’s March 2010 silicon breast implant recall.

Researchers found that there was a breast implant rupture rate of 15.9% to 33.8%, and in many cases the women were unaware of the ruptures until they underwent ultrasound scans.

The study also highlighted a major problem with measuring the health risk and impact of breast implants: getting women to participate in the study. Of the 453 women they identified, 180 could not be contacted and 47 declined to participate. Many had also had their implants removed or replaced before the study took place.

Manufacturers have previously reported that they have problems keeping women enrolled in silicone breast implant studies, which the FDA indicates it needs to be able to accurately assess the risks and side effects of the products.

A number of serious complications have already been linked to silicone breast implants, including implant rupture, wrinkling, asymmetrical appearance, scarring, pain and infection.

The FDA has called on manufacturers, including Johnson & Johnson and Allergan, to find ways to improve participation by women in post-marketing silicone breast implant studies so that there will be better data on the long-term effects of the implants.

The FDA has issued several warnings to consumers regarding silicone breast implant side effects. In January 2011, the FDA also warned that both silicone and saline breast implants may be linked to a form of cancer known as anaplastic large cell lymphoma (ALCL). While it can form in the breasts, it is not considered breast cancer. No cases of ALCL were diagnosed among participants in the latest study.

Women who are considering receiving silicone gel-filled breast implants have been advised by federal health regulators that they should be aware that the implants are not lifetime devices and that the longer they have them, the more likely they are to suffer complications.