Thursday, June 23, 2011

FDA Updates Safety Data for Silicone Breast Implants

Yesterday, the FDA published this press release:  FDA provides updated safety data on silicone gel-filled breast implants

In November 2006, the FDA approved silicone gel-filled breast implants for breast augmentation in women over age 22 and for breast reconstruction in all women. 

This latest report includes preliminary safety data from post-approval studies conducted by each of the two breast implant manufacturers (Allergan and Mentor), a summary and analysis of adverse events received over the years by the FDA, and a comprehensive review and analysis of recent scientific publications that discuss the safety and effectiveness of silicone gel-filled breast implants.

Based on the report, women should know:

  • 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.

 

At this time, the FDA is recommending that health care professionals and women who have silicone gel-filled breast implants do the following:

  • 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.

 

Related Posts: 

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)

………………………………

Okay, now I want to rant just a bit about some of the headlines I found on this story.  All of these headlines were under the Google news/health section this morning.  I am not fond of misleading or sensationalized headlines, especially when it comes to health news.  This topic is serious to all women who have implants and they don’t deserve to be misled or inappropriately scared.

I did not read each of the following articles.  I am only commenting on my “gut” reaction to their titles.

 

Examples of headlines I find appalling:

Celebs who should worry about FDA's breast implant alarm (PHOTOS) (International Business Times)

Hollywood celebrities will not keep breast implants for life (Daily Gossip)

FDA: Silicone breast implants have expiration date (The Imperfect Parent) 

Bummer! FDA Says Women Can't Keep Breast Implants for Life (HyperVocal (blog))

Women who are celebrities are no different when it comes to implants than other women.  No implant has a specific expiration date.  Implants are man-made and wear out over time.  A small percentage fail in the first few years, about 20% fail by 10 years, the other 80% last more than 10 years.

The FDA did not say “women can’t keep breast implants for life.”  The FDA did make it clear that no implant currently on the market has a life expectancy equal to the normal life expectancy for a woman.

 

These headlines I applaud:

FDA: Silicone Implants 'Mostly Safe' and None Last Forever (33 KDAF-TV)

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)

No comments: