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

The following video from Associated Press briefly explains the situation.

According to a New York Times article, Chavez appeared on state television last weekend to denounce Venezuela’s burgeoning breast enhancement market, criticizing the amount of money spent on cosmetic procedures and shaming plastic surgeons who Chavez says “convince some women that if they don’t have some big bosoms, they should feel bad.”

Leading Venezuelan plastic surgeon Dr. Ramon Zapata disagreed with Chavez’s take on cosmetic breast surgery, saying, “I don’t think there should be any type of discrimination against these aesthetic procedures.”

El Nacional, an opposition newspaper, unsurprisingly also contested Chavez’s comments, comparing the Venezuelan leader to Libyan leader Muammar el-Qaddafi and saying, “Now comes this antiquated, militaristic, coarse, repressive attitude on the freedom of women to do what they want with their bodies.”

Regardless of whether one agrees with Chavez’s comments, they are well-timed in their delivery. Billboards in the country’s capital advertise loans for plastic surgery, gossip blogs teem with talk about cosmetic enhancement and the Venezuelan Society of Plastic Surgeons estimates that between 30,000 and 40,000 Venezuelan women seek breast implant surgery each year.

Although Chavez has questioned the motives of breast augmentation patients, asking, “What is this, friend?!” he has not yet taken any action to prevent the thousands of Venezuelan women who desire bigger breasts from seeking plastic surgery, nor Venezuelan plastic surgeons from offering the procedure.

The leading theories for implant rupture include….

1. Aging of the implant elastomer shell
2. Excessive handling or stressing the implant during surgery
3. Excessive stress on the implant due to trauma or intense physical activity
4. Over filling or under filling of the implants.

The underlying result of all these theories is damage to the silicone elastomer shell resulting in microscopic fractures or areas of weakness leading to failure.  So the question is, do you really know when the implant will fail?  Unfortunately it might be within 5 years of placement or never.

So what happens when a breast implant fails?

If a saline breast implant fails it’s usually pretty obvious.  If the implant develops a catastrophic failure then the implant will fail like a tire blow out.  And it’s inevitable that this will occur when you’re getting ready to go out for a dinner party or the like.  Occasionally the implant will develop a small leak that is only obvious after it has been leaking for several days and the volume decreases enough to appreciate.  In either case it’s important to make an appointment with your plastic surgeon as soon as possible to avoid having to wear extra padding in the bra.

If a silicone breast implant ruptures you’ll never know it.  The reason is that the capsule that develops around the breast implant will contain the silicone gel.  In the older style implants some of the silicone oils could migrate through this capsule.  However, silicone is inert and this oil did not result in any disease or disorder (contrary to popular claims made by the media).  Today the cohesive gel implants that we use have silicone that does not migrate and thus are even safer than the previous implants.  And if you have any concerns, the “gummy bear” implant should ease your mind.

If the saline breast implants rupture, then the breast implant repair process is simple.   The old implants are removed and new implants of equal size are inserted.  The surgery should be performed within a few weeks of rupture to prevent contracture of the pocket.  If a breast lift or other procedure is necessary, that can be discussed with your surgeon.  If a silicone breast implant ruptures it’s a sticky, gooey mess.  The capsule and implant should be removed together if possible, but that is often impossible and removal of the old silicone can become tedious.  Once all of the silicone gel is removed the new implants – silicone or saline -  can be put in place.

While it may be stressful, don’t worry when your implant ruptures.  There’s time to correct the situation and return your breasts to their previous state.  Call Dr. Hess at 703.752.6608 and he’ll help you regain the appearance you desire.