Are Polyurethane foam breast implants safe?

Aug 3, 2011 by

Yes. Polyurethane foam breast implants are safe. No doubt. How can I be so sure? Simple:

  1. Commonly Used Around the World & Common sense- if they Polyurethane foam mammary implants were not safe, how could they be used in over 35 countries (this as of August 2011) and in leading countries like the United Kingdom, Australia, Mexico and Germany? Wouldn’t the world know if women were being harmed by these implants as Polyurethane breast implants are being used everyday.
  2. What happened to the 110,000 women that had- according to the USA FDA- Polyurethane foam breast implants implanted in them in the late 1980’s and early 1990’s? The FDA said the Polyurethane breast implants DID NOT need to be removed after reviewing tests about Polyurethane; so 110,000 women have been walking around with these implants for over 20 years and we haven’t seen media reports about complications?
  3. How could Polyurethane foam breast implants be approved in various countries by the country’s regulatory department? Are all those countries- England, Australia, Germany, Italy etc- wrong?
  4. History- Polyurethane foam silicone gel implants have been used for over 40 years, Polyurethane foam implants were used BEFORE textured implants. Polyurethane foam is not some “new” creation, these implants have been used all over the world with great success and safety.
  5. Studies- oh, how I could bore you all to sleep on your fancy iMac keyboards with long term medical studies. Studies that follow patients with Polyurethane foam implants for 15 years and find the furry brazilian Polyurethane foam implants are not only safe, but also reduce capsule contracture, rotation and wrinkling. I’ll post links to some of these studies, but they track large numbers of patients for years with positive findings. Findings that should be considered by governing bodies in the USA and other countries were Polyurethane foam breast implants are not used. A few posts on this website to read:

In the end, it seems the USA FDA things Polyurethane foam are safe, this is taken directly from the FDA website (link below):

Polyurethane Foam-Coated Breast Implants

This section is applicable to those women who received a polyurethane foam-coated breast implant.

Until the polyurethane foam-coated breast implants were taken off the market in 1991 because of concerns that the coating might increase the risk of breast cancer, about 10% of women with breast implants received the polyurethane foam-coated type of breast implant. The polyurethane foam coating released small quantities of the chemical called TDA (2,4-toluenediamine) that has been shown to cause cancer in animals.

Because of this concern, the manufacturer of the polyurethane foam-coated implants, Bristol-Myers Squibb Company, analyzed the urine of women with these devices for TDA.63 Researchers found TDA in the urine but in such tiny amounts that the risk of cancer from the polyurethane foam-coated implants is only about one in a million over a woman’s lifetime. Therefore, it is unlikely that even one of the estimated 110,000 women who got the polyurethane foam-covered implants will get cancer as a result of exposure to the TDA. This study supports FDA’s recommendation that women with polyurethane foam-covered breast implants should not have them removed based solely on concerns about cancer from TDA.

Concerns have also been raised about whether the TDA from the polyurethane foam-coated implants could increase the risk of cancer to a nursing infant. FDA required the company to analyze mother’s milk for TDA, but the company was unable to get enough lactating women with these implants to conduct a valid study.

link: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/BreastImplants/UCM064158

 

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