FDA Update on Silicone Gel Breast Implants

Dr. William Maisel, Chief Scientist and Deputy Director of the Agency’s Device Division, has declared silicone gel breast implants safe and effective after a two day meeting to review all the data since silicone gel breast implants were FDA approved in 2006.  Dr. Maisel said that he knew silicone gel implants were safe before going into this meeting, but stated that this meeting was a review of all new information that has been generated in the last 5 years since the approval in 2006.  These post approval studies have been ongoing since then by both Mentor and Allergan Natrelle, and the focus of these studies was to determine durability and the potential for rare complications.

Adjunct studies conducted between 1992 and 2006 produced evidence that silicone gel implants were safe and effective, but like saline implants, had frequent local problems associated with them, including capsular contracture, implant malposition, rupture, and the need for revision surgery.  During this period it was determined that there was no evidence of a cause and effect relationship between silicone gel implants and connective tissue diseases, breast cancer, or other systemic illnesses.  However, the FDA wanted to continue obtaining long term data on implant durability and to continue surveillance on the possibility of rare complications through post approval studies.

These post approval studies involved questionnaires for patients, doctor’s examination, and MRI follow up on a regular basis.  The data obtained from these studies so far confirmed that silicone gel implants are safe and effective as previously stated.  However, the follow up rate on these patients was less than anticipated, due to poor compliance with doctor appointments and obtaining an MRI, a costly and time consuming test.  Based on the evidence however, the FDA is satisfied with data so far and, along with the American Society of Plastic Surgery will continue to urge patients and doctors to enroll in these studies.  Previous recommendations to have frequent and early MRI examinations will be modified to ‘regular’ exams whose timing will be up to the patient and doctor.

If you have any additional questions on Silicone Gel Breast Implants feel free to contact our Beverly Hills Plastic Surgery office.