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/>

Although form stable breast implants have been approved in Europe for more than 15 years, the FDA still mandated extensive testing here in the U.S. Currently, more than 8000 patients in the U.S. have the Style 410 breast implant, a form stable implant that has proven to have a lower rate of complications and revisions compared to routine round silicone and saline implants.

Dr. Bradley Bengtson, MD, FACS, a lead investigator in the trials, explains the main advantages of the Style 410 gummy bear implant, compared to current silicone gel implant technology. He also clarifies who is an ideal patient for the Style 410, and who should consider a smoother round silicone implant.

Click the player to view the interview.

Cohesive gel implants have been used for 10 years in Europe but are still unproven in U.S. clinical trials. However, this new breast implant technology has shown some qualities that may make them preferable over saline filled or silicone gel implants in future breast augmentation surgeries.  According to some experts, due to the thick layer of gel, cohesive gel implants are:

•    More durable

•    Less prone to rippling and leaking
•    Not likely to collapse or fold
•    Better at retaining form and stability, enabling the shape of the implant to remain the same in any position

Despite these advantages, cohesive gel implants do not shift or change shape once they are inserted, and all cohesive gel implants are the same teardrop shape that may not appeal to all women. Cohesive gel implants also feel firmer than older types of implants. Other risks include rotation, which can distort the shape of the breast, and possible fracturing, which is possible given the “solid” nature of the implants.

Cohesive gel breast implants, though, are not for everybody.  In the United States, women who are found to have certain medical health problems (a prior check up is mandatory) are not eligible for such implants. Aside from this, the FDA imposes a precondition that patients who receive these implants are required to commit and submit to a follow-up period of 10 years. In addition, not all plastic surgeons in the U.S. can perform cohesive gel implants. Only those who have been approved for participation by silicone gel manufacturers (under FDA scrutiny) in the adjunct study can do it.

Notwithstanding the potential of cohesive gel breast implants to make improve the size and shape of the breasts, one should be aware of all the advantages and disadvantages of this new cosmetic technology. It is important to research all the possible results and risks before deciding to get cohesive gel breast implants.