Many complaints and lawsuits were made against manufacturers of silicone gel breast implants during the 1980’s after women experienced implant ruptures.
Though the product was reintroduced to the market in 2006 (after a fourteen-year FDA ban), these implants still aren’t without their risks.
FDA ban
Silicone implant ruptures created safety concerns that led the FDA to ban silicone gel breast implants from the general market in 1992, leaving only saline implants and autologous tissue reconstruction as options for women who had a mastectomy.
A mastectomy is a surgery that removes an entire breast to eliminate or prevent breast cancer. Silicone gel implants became an option for these women again in 2006, after FDA studies concluded that silicone gel implant ruptures were not connected to greater conditions, such as cancer, lupus or rheumatoid arthritis.
Today’s risks
Breast reconstruction surgery can happen directly following the mastectomy or any time after the mastectomy incisions have healed and breast cancer treatment is finished. However, surgery and its results may have complications, such as:
- Implant rupture
- Implant deflation
- Incision infection
- Changes in breast sensation, including loss of sensation or pain
- Bleeding
- Scaring or wrinkling
- Capsular contracture (unnatural shape or texture)
- Asymmetric breasts
A 2000 Institute of Medicine report found that some studies indicated 77 percent of women experiencing breast implant ruptures. However, other studies found only .3% of implanted women experiencing a rupture.
Ruptures in silicone breast implants are especially high risk, because they can only be detected by MRI. These ruptures can be caused by a fall or puncture, but they may also be caused by surgical error.
If you are experiencing an issue with a breast implant, it may very well be due to the negligence of a manufacturer or medical professional. Contact an attorney to discuss the legal options you may be able to pursue.