- Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients who received implants for breast augmentation will need them removed within 10 years of implantation. For patients who received implants for breast reconstruction, as many as 1 in 2 will require removal 10 years after implantation.
- The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain, and infection. Check out the FDA booklet for patients: Breast Implants Complications Booklet.
- Preliminary data do not indicate that silicone gel-filled breast implants cause breast cancer, reproductive problems or connective tissue disease, such as rheumatoid arthritis. However, in order to rule out these and other rare complications, studies would need to enroll more women and be longer than those conducted thus far.
- Follow up. Women should continue to routinely follow up with their health care professionals. The FDA recommends women with silicone gel-filled breast implants undergo MRI screening for silent implant ruptures at 3 years post-implantation, and every 2 years thereafter.
- Be aware and pay attention to changes. Breast implants are not lifetime devices. Breast implants are associated with significant local complications and outcomes, including capsular contracture, reoperation, removal, and implant rupture. Some women also experience breast pain, wrinkling, asymmetry, scarring and infection. Women should notify their health care professionals if they develop any unusual symptoms.
- Stay in touch. If a woman has enrolled in a manufacturer-sponsored post-approval study, she should continue to participate. These studies are the best way to collect information about the long-term rates of complications.
It’s Happened Again (June 5, 2007)
Breast Implants -- Some History (March 3, 2008)
Silicone vs Saline Breast Implants (March 4, 2008)
Silicone Implants and Health Issues (March 5, 2008)
Saline or Silicone? (November 18, 2010)
More on Link Between Breast Implants and ALCL (April 25, 2011)
FDA: Silicone breast implants have expiration date (The Imperfect Parent)
Bummer! FDA Says Women Can't Keep Breast Implants for Life (HyperVocal (blog))
Silicone implants not a lifetime device (UPI.com)
Both are simple with no fear tactics included.
These headlines I find acceptable:
FDA stands by decision to put silicone breast implants back on market (Los Angeles Times)
FDA Says Silicone Breast Implants Are Safe For Women (SmartAboutHealth)
FDA Leaves Silicone Implants on Market Despite Risks (Wall Street Journal)
Breast Implants Basically Safe but Not Lifetime Devices, Say Experts (ABC News)
Breast implants reasonably safe (Washington Post)
Breast implants 'relatively safe' (BBC News)
FDA urges caution for silicone breast implant recipients (Boston Globe)
FDA Sees No New Safety Signals for Silicone Breast Implants (MedPage Today)
Most women with silicone breast implants need more surgery (msnbc.com)
Breast implants safe but not problem-free, FDA says (CBS News)
Silicone Breast Implants Deemed Safe in FDA Side Effects Review (Bloomberg)
Long-Term Complications Likely With Silicone Breast Implants (Medscape)