If your saline-filled breast implant ruptures, you or your doctor will be able to tell. When saline-filled breast implants rupture, they deflate and the saline solution leaks into your body immediately or over a period of days. You will notice that your implant loses its original size or shape. If your silicone gel-filled breast implant [...]
Posts from ‘May, 2009’
Breast implants rupture
We do not know all of the causes of breast implant rupture. We do know that breast implants can rupture from: damage during implantation or during other surgical procedures folding or wrinkling of the implant shell trauma or other excessive force to the chest compression of the breast during mammography. Source: http://www.fda.gov/
How long do breast implants last?
Breast implants do not last forever. If you decide to get breast implants, you will likely need additional surgeries on your breasts over your lifetime due to rupture, other complications (for example, capsular contracture, breast pain), or unacceptable cosmetic outcomes (for example, asymmetry, unsatisfactory style/size, wrinkling/rippling). Source: http://www.fda.gov/
Breast Implants Reoperation
it is likely that you will need to have one or more reoperations over the course of your life because of local complications from breast implants. Reasons for reoperations could include any of the potential local complications bulleted above, such as capsular contracture, wrinkling, asymmetry, rupture/deflation, implant malposition, etc. The type of surgical procedure(s) performed [...]
Potential local breast implant complications
You may need non-surgical treatments or reoperations (including removal of your implant) to treat any of these local complications. Potential local complications include, but are not limited to: . Asymmetry . Inflammation/irritation . Breast pain . Malposition/displacement . Breast tissue atrophy . Necrosis . Calcification/calcium deposits . Nipple/breast sensation changes . Capsular contracture . Palpability/visibility [...]
Key points to consider whether you are undergoing breast augmentation, reconstruction, or revision
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 [...]