Recently, the FDA (Food and Drug Administration) approved a new breast implant made from silicone gel. However, the FDA says that they have only approved the implant on the proviso that the firm Mentor Worldwide monitors the female users of it, and investigates its’ effects over the long term. On Friday, the agency granted approval to Mentor Memory Shape Breast Implants to begin using its new silicone gel implant in procedures involving females over 22 years of age, and to repair breast tissue in females of all ages.
This sanctioning means that there are now five gel-filled silicone breast implants on the market in the US, which have been approved by the FDA. In addition to Mentor, there are two other firms that supply these breast augmentation implants, Sientra and Allergan. These kinds of announcements are always likely to be controversial, but the FDA remains steadfast, claiming that women have a “reasonable expectation” of safety.
The Rationale Behind the Approval
In a recent statement, representatives from the FDA said that their new approval is justified by six years worth of data acquired from 955 women. Purportedly, this data shows that these implants will be effective and safe. Mentor Memory Shape breast implants display similar kinds of problems to those that have been discovered in previously sanctioned breast implants. These problems include a tightening of the region round the breasts, the requirement for eventual implant removal or re-operation, wrinkling and uneven appearance. Also, the FDA has reported that, in some Memory Shape implants, cracks were noticed in the gel.
Views From the Experts
The FDA Center for Radiological Health and Devices director, points out that breast implants aren’t meant to be devices that last for a whole lifetime. Indeed, women should make sure they fully comprehend the risks related to breast implants, prior to undergoing reconstructive plastic surgery or breast augmentation. Further, women need to acknowledge that long term medical supervision is vital.
Conditions of the Approval
The FDA sanctioned these new implants on the understanding that Mentor Memory Shape carries on following the 955 females, in the main study, for a decade. Also, the firm has to spend half a decade following 350 extra subjects, who have been implanted with a particular type of Memory Shape device. Furthermore, the firm has to carry out another decade long study of 2, 500 females, who have purchased Memory Shape devices. This is to assess the risks of long-term complications.
Moreover, the firm has to carry out 5 case control tests on 10, 750 females, to examine possible links between breast implants made with silicone and five rare diseases. These diseases are: neurological disease, rare connective tissue disease, lymphoma, cervical cancer and brain cancer. Also, Mentor Memory Shape, based in Santa Barbara, California, are required to analyze female perceptions of the packaging used for the implants. According to the FDA, the firm has to evaluate all the Memory Shape products that are returned by customers as well.