Breast implants will not last a lifetime. Either because of rupture or other complications, you will likely need to have the implants removed. You are likely to need additional doctor visits and reoperations because of one or more complications over the course of your life. You are likely to have the implants removed, with or [...]
The risks of breast implants
Some of the risks of breast implants include: reoperations (additional surgeries), with or without removal of the device capsular contracture (hardening of the area around the implant) breast pain changes in nipple and breast sensation rupture with deflation for saline-filled implants rupture with or without symptoms for silicone gel-filled implants migration of silicone gel for [...]
How can I participate in a breast implants clinical study?
Information about participation in a clinical study can be obtained from the companies conducting the study. See the company contact information at http://www.fda.gov/cdrh/breastimplants/addsources.html. Source: U.S. Deparment of Health and Human Services
Several ongoing clinical studies of saline and silicone gel-filled breast implants
There are several ongoing clinical studies (i.e., investigational device exemption (IDE) applications) of saline and silicone gel-filled breast implants. These studies include those for the more cohesive silicone gel-filled breast implants manufactured by Mentor and Allergan (formerly Inamed), as well as studies conducted by other manufacturers. These devices are still in research and have not [...]
The age minimum is different for augmentation for saline-filled and silicone gel-filled breast implants?
FDA approved saline-filled breast implants for augmentation in women ages 18 and older. FDA approved silicone gel-filled implants for women ages 22 and older. The age restrictions are different because the risks are different for the two products. For example, silicone gel-filled implants will require frequent MRI monitoring to detect silent rupture (a rupture that [...]
Age limits to get breast implants
Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older. Mentor and Allergan silicone gel-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any [...]
How are breast implants used?
Breast implants are used for: primary augmentation (to increase breast size for cosmetic reasons) revision-augmentation ( revision surgery to correct or improve the result of an original breast augmentation surgery) primary reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a [...]
What types of breast implants are approved by FDA?
FDA has approved four breast implants for marketing in the U.S.: In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age. In November 2006, Allergan and Mentor received approval [...]
What are breast implants?
Breast implants are medical devices that are implanted either under breast tissue or under the chest muscle for breast augmentation or reconstruction. There are two major types: saline-filled and silicone gel-filled. Saline-filled breast implants are silicone shells that are either prefilled or filled with saline during surgery, and some of these allow for adjustments of [...]
