A Ban Lift On Silicone Breast Implants Opens Your Options Even More

Is Silicone a Safe Option for Breast Implants?

For decades, the use of silicone breast implants was hotly contested in the medical community.

Doctors, patients and lawmakers could not agree whether their use in cosmetic surgery was a safe investment.

Now the argument is finding a definitive end and this might be good news if you are considering breast augmentation!

On November 17, 2006, the FDA lifted a 14-year ban against the use of silicone breast implants in cosmetic surgery. Then in January of 2007, they released an official statement giving the okay for two major medical companies to begin manufacturing once more.

Before these announcements, hundreds-of-thousands of lawsuits were filed on behalf of women whose implants had ruptured. They claimed that the silicone-gel had entered their body and was responsible for medical ailments including cancer, lupus and other autoimmune disorders.

Years Of Intense Research Help Make Decision

After carefully monitoring the progress of over 40,000 women for 10 years, comparing clinical and pre-clinical studies, investing in research from independent firms, and talking with multiple advisory panels, the FDA now believes there is no evidence that silicone implants are a health risk to anyone.

The Institute of Medicine released their own findings which support the FDA ruling.

Why were they Initially Taken Off the Market?

One of the major reasons that silicone implants were removed from the market was the fear that they created autoimmune disorders in women.

An autoimmune disorder is a condition that occurs when the immune system mistakenly attacks and destroys healthy body tissue.

One example is called Connective Tissue Disease (CTD).

CTD is any disease that affects the pathology of your biological tissue. The body's biological tissue is what supports the framework for your structural organs. It consists of two major proteins which may sound familiar: collagen and elastin. Both proteins are important in the function of the ligaments and skin.

When someone contracts CTD there may be an inflammation of the ligaments, brought about because the immune system mistakenly begins to attack its own body. This inflammation can lead to more serious complications.

FDA Imposes Stipulations To Guarantee Your Safety

Even after giving their approval, the FDA still places silicone implants under a stringent set of rules that they say are designed as an added safety precaution for you, the consumer.

The two companies granted permission to manufacture the implants, Allergan and Mentor, are both California-based.

They can create silicone implants as long as they are used for breast reconstruction to a certain age specification. Patients wanting silicone breast augmentation must be ages 22 and older.

For added health safety, the FDA also requires that companies who manufacture silicone implants:

  • Conduct a large post-approval study
  • Continue the study for 10 years.
  • Continue laboratory studies to further characterize types of device failure.
  • Track each implant in the event that health professionals and patients need to be notified of updated product information.

Additional Warnings To Be Aware Of

The FDA also warns that:

  • Breast implants are not lifetime devices, and a woman will likely need additional surgeries on her breast at least once over her lifetime.
  • Many of the changes to a woman's breast after implantation are irreversible.
  • Rupture of a silicone gel-filled breast implant is most often silent, which means that usually neither the woman nor her surgeon will know that her implants have ruptured.
  • All women will need regular Magnetic Resonance Imaging (MRI) examinations over her lifetime to determine whether silent rupture has occurred.

Decades Of Global Research Agree With FDA Findings

For decades, researchers all over the world have turned up similar results to the ones that the FDA is now using to approve silicone implants.

  • In 1996, French scientists stated: "We did not observe connective tissue diseases to be directly or indirectly associated with (in particular) silicone gel breast implants.
  • Germany released a statement in 1998 concluding that "silicone breast implants cause neither auto-immune diseases nor rheumatic diseases and have no disadvantageous effects on pregnancy, breast feeding capability or the health of children who are breast fed. There is no scientific evidence for the existence of silicone allergy, silicone poisoning, atypical silicone diseases or a new silicone disease.
  • A 2001 US review presented before the National Science Panel concluded that there was no evidence of an association between breast implants and these CTDs.
  • A 2003 report done in Spain stated that the currently available information shows that there is not solid evidence linking silicone breast implants to severe diseases (such as breast cancer or connective tissue diseases).
  • A 2004 Danish study reported that women who had breast implants for an average of 19 years were no more likely to report an excess number of rheumatic symptoms then control groups.