By Caroline Glicksman, MD
ThePlasticSurgeryChannel.com

The French breast Implant Crisis Escalates

Last year, the French based company PIP (Poly Implant Prothèse) had their implants banned because it was discovered that they were utilizing a non-medical grade silicone as the filler for their gel implants.

In addition, the recent reported death of a French woman from the rare form of cancer ALCL, who had PIP breast implants has led to a tremendous amount of media concern about a company recognized by few American women.  Inspections in France as early as 2001 had revealed numerous non-conformities surrounding the manufacture of PIP implants. In 2009, it was reported that there were high rupture rates with their implants in France, leading to allegations of implant shell problems. In 2010 distribution was suspended and the company filed for bankruptcy.

PIP appears to have used two types of silicone gel within their breast implants; the “Medical Grade” silicone manufactured by Nusil, (made in US and France), and a less expensive formula that they claimed was chemically identical. When implant manufacturers describe their silicone gel, they often uses terms such as “Industrial Grade”, “Medical Grade”, “Health Care Grade” and even “Implant Grade.” These terms can differ around the world.  There are multiple tests for silicones including mechanical, chemical, animal, biochemical, cell culture tests and clinical evaluations that are required to determine what silicone formulations are safe for long term human implantation.1 Summing it up, “Medical Grade” silicones are those that have passed extensive, strict biological testing, and in the United States the manufacturers must formally submit their data to the FDA for approval.

The fallout from the French Breast Implant Crisis discovery has left women worldwide confused and worried.

It appears that various European and South American Health Ministry’s are offering different options to women who have these devices.  While France is offering to pay for the removal and replacement of PIP implants used in breast reconstruction, Venezuela will pay for explantation only. Other European nations, such as the Netherlands, Ireland, Austria, and Denmark, to name a few, are suggesting only close follow-up of women who have these devices. Each health ministry, as well as the FDA, has repeated their conclusion on breast implants that although there may be a very low but increased risk of developing ALCL adjacent to breast implants, with less than 70 cases reported in the world literature to date, these represent a very small fraction of the 5-10 million women who have received breast implants worldwide. In addition, PIP implants have not played a significant role in the US market since the company’s 2000 request to market saline implants in the US was denied. The silicone implants that are presently used in the United States are manufactured by Allergan, Mentor and Silimed/Sientra, and must all meet the strict requirements of our FDA.

Finally, as with all silicone gel breast implants, there is no exact expiration date. No implant will last a life-time, and all silicone implants, regardless of their manufacturer, should be followed and imaged as they age.

1 Allistar Winn, Manufacturing and FDA Compliance Support, date accessed 12-29-11, date modified October 10, 2011. <http://www.appliedsilicone.com/selecting-the-proper-grade-of-silicone-and-test-protocol/>

Dr. Peter Rubin with Dr. Oz

Using Stem Cells to Re-Grow Breast Tissue

On Friday, December 16, 2011, Dr. Rubin along with Dr. Oz and Suzanne Somers discussed the role stem cells may play in plastic surgery. Dr. Rubin says, “We are optimistic about stem cell based technologies for breast reconstruction, and need to approach the topic cautiously and with great respect for the safety of our patients. These are experimental therapies, and we need to collect data under approved clinical studies to be able to tell if this will be safe and effective.”

On the Dr. Oz Show, Somers opened up about her battle with breast cancer and the stem cell surgery that she says, helped reconstruct her breast. Somers’ procedure is considered to be a minimally invasive method of restoring breast volume using fat moved from another part of the body.

Consumers Should Use Caution

Despite celebrity endorsements, Dr. Rubin says consumers really need to be cautious when considering stem cell therapies. He says, “The biggest problem encountered with fat grafting is that fat can lose volume or be absorbed by the body over time leaving less of an affect from the original treatment.”

As a practicing plastic surgeon and a scientific researcher in stem cells, Rubin says, “There are encouraging data from laboratory and clinical studies to suggest that the use of adult stem cells is a very promising field, but as our comprehensive review of the current scientific literature shows, the data available today do not substantiate the marketing claims being made to patients seeking aesthetic surgery and aesthetic medical treatments.”

Dr. Rubin recently led a special joint task force to research and address concerns over claims and clinical practices using stem cells that have not been substantiated by scientific evidence.  As a medial advisory  board member for the ThePlasticSurgeryChannel.com, Rubin details some of the confusion over stem cells in the following videos:

1. Researchers Explore Stem Cell Facelift
2. Plastic Surgeons Say Do Not Believe the Stem Cell Hype
3. Stem Cell Facelift Pittsburgh, Pennsylvania-Dr.-Rubin

The two leading plastic surgery associations, the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS), back up Rubin’s statements saying, “While there is tremendous potential for the future use of stem cells in aesthetic surgical procedures, the scientific evidence and other data are very limited in terms of assessing the safety or efficacy of stem cell therapies in aesthetic medicine.

Rubin wants patients to know that while this technology is promising, it is an experimental treatment and should only be done as part of an approved clinical trial.   He says patients should always see a board certified plastic surgeon for a proper evaluation before considering any stem cell procedure.

About The Plastic Surgery Channel

The Plastic Surgery Channel is a company devoted exclusively to educational programming about cosmetic and reconstructive surgery. Our goal is to provide credible, up-to-date information to people considering plastic surgery or a cosmetic procedure, as well as coverage of the latest news and hot topics from the field of plastic surgery.

Unlike shows you might see on network or cable television, the programming on The Plastic Surgery Channel does not strive to be sensationalist, focusing solely on extreme cases, nor is it solely devoted to a documentary-style overview of various medical procedures. Rather, we strive to inform — and in some cases entertain — viewers by providing relevant, engaging content that covers all facets of cosmetic and reconstructive surgery. We rely on experienced, board certified leaders in the field as content consultants, and conduct substantive research to verify the accuracy of the articles and videos that we present.

Of course, The Plastic Surgery Channel is not meant to replace the advice of medical professionals. Viewers are reminded to always consult a medical professional before making any decisions about plastic surgery or any other form of surgery.

For more information about our programming and our faculty, please email us at info@theplasticsurgerychannel.com