Clinical Trials for Silicone Implants

Currently, two major medical device companies, Allergan and Mentor Corporation, manufacture silicone gel-filled breast implants. Both have been conducting long-term clinical trials in answer to the FDA's call to prove that silicone gel-filled implants are affirmatively safe and effective.

The FDA's decision to approve silicone gel implants was based on a thorough review of each company's clinical (core) and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. In addition, the FDA conducted inspections of each company's manufacturing facilities to determine that they comply with FDA's Good Manufacturing Practices. Some of the complications reported in the core studies included hardening of the area around the implant, breast pain, change in nipple sensation, implant rupture and the need for additional surgery. However, the majority of women in these studies reported being satisfied with their implants.

The silicone gel-filled breast implants were FDA-approved yet with a number of conditions, including requiring Allergan and Mentor Corporation to: conduct a large post-approval study; continue its core study through 10 years; conduct a focus group study of the patient labeling; continue laboratory studies to further characterize types of device failure; and track each implant in the event, for example, that health professionals and patients need to be notified of updated product information.

The post-approval studies will continue to gather information about the safety and effectiveness of the implants.  Information will be collected about rates of local complications, rates of connective tissue disease and its signs and symptoms, rates of neurological disease and its signs and symptoms, potential effects on offspring of women with breast implants, potential effects on reproduction and lactation, rates of cancer, rates of suicide, potential interference of breast implants with mammography, and MRI compliance and rupture rates. The post-approval studies will be closely monitored by the FDA.

Allergan                                                                                                                      

Allergan is conducting several clinical trials on silicone-filled breast implants.  Two studies which are closed to patient accrual are the following:

• the core gel clinical study of the company’s INAMED^® Silicone-Filled Breast Implants.  Over 10 years, 940 patients will be followed. 
• the core clinical study of the company’s INAMED^® Style 410 Cohesive Silicone Gel-Filled Breast Implants.  Over 10 years, 940 patients will be followed. 

To inquire about Allergan’s breast implant options, visit www.breastimplantstoday.com.

Mentor Corporation                                                                                                    

Mentor Corporation is conducting two clinical trials: (1) the core gel clinical study of Mentor’s Round Silicone Gel-Filled Mammary Implants. Over 10 years, 1,000 patients will be followed; (2) the Contour Profile Gel Clinical Study. Over 10 years, 950 patients will be followed.These trials are closed to accrual.

To inquire about Mentor Corporation’s breast implant options, visit www.mentor4me.com.