The breast implant manufacturer, Allergan, has released a statement distancing itself from the Poly Implant Prosthese (PIP) breast implant controversy happening in France.

As maker of popular breast implant products such as NATRELLE, McGhan and CUI, the company is in no way affiliated with PIP and seeks to reassure patients and surgeons that Allergan products are of the highest quality and safety.

Allergan breast implants have been on the market for almost 50 years. The products are available in over 60 countries and are subjected to rigorous national and international quality control standards and practices.

Among the many products manufactured by Allergan every year, silicone gel-filled breast implants are by far the most favored among both patients and surgeons. The gel-filled implants have been placed in more than 1 million women worldwide.

As a result of hundreds of thousands of clinical trials, peer-reviewed journals and published reports, silicone gel-filled breast implants have become one the most studied devices in the world. Allergan’s gel-filled implants specifically, have set themselves apart from various competitors due to their more cohesive silicone gel and their stronger outer shells.

A recent report published by the U.S. FDA has again confirmed the safety and effectiveness of silicone breast implants when used as intended, however, it is important for patients to recognize that breast implants are not made for lifelong use.

Patients at some point in their lives may require a removal and replacement. Breast implants should be monitored regularly by a plastic surgeon.

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In London’s Hunterian Musem, a collection of medical archives is being gathered from World War I. “They are powerful testimony to the advances made by modern surgeons in the past 100 years,” writes Helen Briggs for the BBC, who writes a compelling article about the Gillies Archive and the ways in which war has driven innovation in plastic surgery.

“The war led surgeons to attempt ground-breaking procedures, which paved the way for modern plastic surgery,” said Dr. Andrew Bamji, former curator of the Gillies archive.

“The war led surgeons to attempt ground-breaking procedures, which paved the way for modern plastic surgery.”

- Dr Andrew Bamji

Named after plastic surgery pioneer Sir Harold Gillies, the archives include medical documentation, paintings, plastic casts, instruments and more.

The artifacts tell a story about war injuries and the surgical techniques that were developed to treat them.

You can read more about Dr. Gillies’ work on Wikipedia:

“The Queen’s Hospital opened in June 1917 and with its convalescent units provided over 1,000 beds. There Gillies and his colleagues developed many techniques of plastic surgery; more than 11,000 operations were performed on over 5,000 men (mostly soldiers with facial injuries, usually from gunshot wounds).”

Photo: Sir Harold Gillies by Simon Harriyott, on Flickr

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Two years ago, reports of defective silicone breast implants manufactured by PIP (Poly Implant Prothèse) prompted authorities to halt production of the devices.

The breast implants are said to have a very high failure rate and a non-medical type of silicone gel. France is now encouraging women with these implants to have them removed.

PIP silicone gel-filled implants have never been approved for use in the United States. The only way an American patient would have these implants is if she had undergone breast surgery in another country.

ASPS Monitoring the Situation

The American Society of Plastic Surgeons (ASPS), working with the French Society of Plastic Reconstructive and Aesthetic Surgery, is monitoring the recent developments on PIP silicone gel breast implants.

The ASPS issued a statement to its members practicing outside the United States:

“We believe that while the current focus of attention is in France, approximately 80 percent of PIP implants were exported to other countries including the United Kingdom, Spain, Brazil, Argentina, Chile, Colombia and Venezuela. There are also reports that implants under the brand name “M,” distributed by a Dutch company in Germany – and possibly elsewhere in Europe – may also be PIP implants that were rebranded as “M” implants.”

According to Reuters, Italy is working with cosmetic surgery clinics to compile a list of women who received the implants. Meanwhile, officials in Brazil and Britain are urging women to check in with their surgeons. The French government is recommending and offering to pay for explantation surgery – if the original surgery was for breast reconstruction.

Allergan Inc, American Breast Implant Maker Assures Quality of Their Implants

In response to the French situation, Allergan issued a lengthy press release to reassure surgeons and patients about the quality of their breast implants. Allergan’s products are marketed under the names Natrelle, McGhan and CUI. None of these implants are included in the French investigation.

“The health authorities are specifically concerned about breast implants made by the company called Poly Implant Prosthese (PIP),” states the Allergan Press Release. The release also describes the extensive checks that are in place to ensure quality of their implants. “Allergan maintains rigorous clinical development processes, extensive manufacturing and quality assurance testing, as well as an industry-leading post-marketing surveillance program, to ensure the highest quality and safety of its breast implants that patients and surgeons can rely on.”

AP Video: France Calls for Breast Implant Removal

This one-minute video from the Associated Press briefly explains the situation in France.

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