FDA Approves Natrelle “Gummy Bear” Silicone Breast Implant

Breast implants are used for a variety of reasons, from the purely cosmetic or aesthetic purposes of enhancing one’s appearance through breast augmentation to reducing the appearance of scar tissue and reconstructing breasts after major surgery. While implants offer some of the best cosmetics based alternatives, traditional breast implants have been associated with complications, including tightening of the skin and hardening of the tissue around the prosthetic, the need to undergo further surgery in order to better situate the implant or to remove it entirely, an uneven or rough appearance, and the possibility of infection or leakage of the implant’s contents.

Breast Implants are not Permanent

Health care professionals have advised that breast implants are not meant to be permanent. Those considering this procedure should consider more than just the cosmetics side of the equation, evaluating the risks and benefits associated with breast implants. One of the most important points to consider is that this procedure requires continued monitoring in order to treat any areas of concern as soon as possible so as to avoid more serious consequences.

Innovative Treatments

With this in mind, the Food and Drug Administration, or FDA, has recently given the go ahead to a new breast implant called the Natrelle 410 Anatomically Shaped Highly Cohesive Silicone Gel Filled Breast Implant. This decision was based on the review of nearly a decade’s worth of data from some 940 women who tried the new implant. Based on these data, the FDA has decided that Allergan Inc.’s new implant is reasonably safe. As with all breast implants, there are some possible complications to be aware of. In addition to the typical concerns related to any other breast prosthetics mentioned above, the data on Natrelle indicates that the implant may also exhibit gel fissures, small cracks that may form in the silicone gel filling.

Conditional Approval

As a result, approval is conditional upon Allergan Inc. following a set of guidelines stipulated by the U.S. Food and Drug Administration. The first requires that Allergan follow the progress of 3, 500 implant recipients over the next five years in order to ensure all possible complications are reported.

The company is also responsible for taking on a decade long research project following over 2, 000 women in order to identify long-term complications associated with the Natrelle implant. Of particular concern in terms of longer term consequences of using this silicone gel filled implant are the possibility of implant rupture, as well as some illnesses that may or may not be associated with the use of implants, like certain types of cancer, namely lung and breast cancer, and rheumatoid arthritis. The final stipulation requires that Allergan perform five controlled case studies regarding any possible link between the use of Natrelle implants and five different rare illnesses, like lymphoma and brain cancer.

Breast Augmentation – Long Term Side Effects

In addition to the FDA call for the Natrelle manufacturer to carry out long-term studies of the potential dangers associated with their latest product, potential consumers have also been notified that long-term care is essential. Women interested in using Natrelle or other implants for cosmetic or reconstructive purposes should consult with their doctors before making their decision.