Patricia Yarberry Allen, M.D. is a Gynecologist, Director of the New York Menopause Center, Clinical Assistant Professor of Obstetrics and Gynecology at Weill Cornell Medical College, and Assistant Attending Obstetrician and Gynecologist at New York-Presbyterian Hospital. She is a board certified fellow of the American College of Obstetrics and Gynecology. Dr. Allen is also a member of the Faculty Advisory Board and the Women’s Health Director of The Weill Cornell Community Clinic (WCCC). Dr. Allen was the recipient of the 2014 American Medical Women’s Association Presidential Award.

Dear Dr. Pat,

I am 42 years old and had breast implant surgery in 2004 because my boyfriend of the time wanted me to have larger breasts.  I have never liked the way they look, and they are much too large.  Now I read in The New York Times that the French manufacturer of silicone implants has been ‘detained’ in France because so many of the implants leaked or ruptured and a woman died from a cancer related to the implants.  My implants were placed in New Jersey in 2004 and the surgeon has retired and moved away. What can I do to find out if I am at risk?  Can I get someone to pay for the removal of the implants?

Deborah

Dear Deborah,

Physicians often hear from women who had breast implants because a partner wanted them to have larger, firmer, perkier breasts.  Then the relationship ends but the new and improved breasts stay.  I can understand that you are disappointed in your decision to have the implants placed and that you are understandably anxious about the news you have heard about the French-produced breast implants in the media.

Graphic: Agence France-Presse

The headline in the January 27, 2012, New York Times story was “French Police Arrest Founder of Breast Implant Maker.”  The article reported that  “The founder of a French company that made hundreds of thousands of breast implants from industrial-grade silicone, causing anxiety among women around the world, was detained in a dawn raid on his home in southern France, the authorities said Thursday.”

The article continued, “The company Mr. Mas founded, Poly Implants Prothèses, was closed by the authorities in March 2010 and liquidated, following revelations that it had used silicone that was industrial grade, not surgical grade, to save money on the hundreds of thousands of implants it sold in countries around the world.”

Thousands of women in France, England, and many Latin American countries are having these implants removed, often paid for by the governments of these countries.

To get a better picture of what this means for patients, I have turned to Dr. John Sherman, M.D., F.A.C.S., a Clinical Assistant Professor of Surgery at the Weill Cornell Medical College and a respected breast reconstruction and plastic surgeon, who gives us more of the history behind the scandal, and discusses what this means for women in the U.S.

Dr. Pat

 

Dear Deborah,

At this time, there is no evidence that the PIP silicone implant was ever used in the United States.  So you do not appear to have any cause for concern.

Naturally, when women hear about any potential problem with breast implants they become alarmed. And there has been an ongoing and serious concern about the products of the French breast implant company, PIP, even before the arrest of Jean-Claude Mas. Dr. Mas’s company has not been allowed to even sell its products in the United States, since an FDA evaluation in 2000 uncovered serious issues in a PIP plant in France. Before then, Mas’s previous company was allowed to export a saline implant (not silicone), but those implants often failed, leaving many women abandoned with deflated breast implants.

Americans should be reassured that the PIP silicone implant has not been approved for use in the United States. The FDA moratorium on silicone implants was issued in 2000.  When PIP submitted an application to continue to use the saline breast implants in the US, that application was denied after a site inspection and a letter of warning in June of 2000. This is an example of the importance of the regulation and oversight of all medical devices.

But what about implants that were performed outside the United States? This is where patients have a right to be concerned. For a time, a subsidiary of Dr. Mas’s company was able to sell his newer silicone implants throughout the world:  to South America, UK, and France and across Europe. Re-branded as “M” implants (many with non-medical grade silicone), they were distributed by a Dutch company in Germany. This problem affects over 30,000 women, and possibly multiples of this number.

How dangerous are these implants? We don’t yet know the full effect of nonmedical grade silicone; some may prove to be cancer-causing, especially if a rupture occurs, and there are many contaminants in these products as well. Plastic surgeons all agree that the implants should be removed. In France, patients may now elect to monitor the implant with ultrasound or MRI (at government expense) and then have them removed if the implants seem to be leaking (also covered by government health insurance).

If you are someone who had her breasts augmented outside the United States, my suggestion is that patients who have had breast augmentation in Europe or South America contact their physician to learn about the exact type of implant that was used. If it was a PIP implant, or they cannot find the type of implant that was used, the implants should be removed. Such removal (with replacement, if desired) is a relatively simple outpatient procedure, and the patient is generally able to return to work within days.

In my office, I have seen women who had the implant placed in France and other parts of Europe, and have often been able to ensure that removal here was eventually reimbursed by their insurance carriers and the government agencies involved. Keeping an implant that may be cancer-causing does not make any sense, especially since the remedy is simple. The first step is, of course, talking to your doctor.

 Dr. Sherman

John Sherman, M. D.,  FACS .  devotes most of his New York practice to aesthetic surgery and is highly experienced with  liposuction, breast augmentation and revisional breast surgery, though he specializes in facial rejuvenation and body contouring. He is a member of the American Society of Plastic Surgeons, American Society of Aesthetic Surgery, American Society of Maxillofacial Surgery and currently Vice President of the New York State Chapter of the American College of Surgeons.   

 

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  • Chris Lombardi February 15, 2012 at 9:15 pm

    A reply from Dr. Sherman is below. — Chris Lombardi, Site Editor

    From: Dr. John E. Sherman

    That is an interesting question concerning the placement of PIP implants on an American citizen in France. While there can be little recourse arguing with the French government, it would seem that this patient’s problem should be addressed by her insurance carrier. Some insurance policies do not offer coverage for complications of cosmetic surgery. If this clause is not in the policy, breast implants that are ruptured are covered for the removal but not replacement of the implants. Replacement of the implants is deemed cosmetic
    so that the patient would have out-of-pocket expenses for the replacement of the implants.

    In view of the non-medical grade silicone with these implants, the carrier should cover their removal, the same as a patient with ruptured silicone implants.

    The surgeon should contact the insurance company for appeal if possible. The other possibility would be for the patient to return to her surgeon in France for removal and possibly replacement. I do not believe that
    the government is only covering citizens if the surgery is performed in France. The cost of the trip if scheduled might be less than the similar surgery if performed here in the United States.

    John E. Sherman, MD FACS
    http://www.nyplasticsurg.com

    Reply
  • Tonya Leonard February 15, 2012 at 12:39 pm

    I am an american, and live in New Hampshire. I have the PIP implants. My husband is was military and we live overseas for a few years, and I had the implants placed there. It seems that I cannot get anyone to help me in the US. And the French govt, say that I am not a native, therefore would not help me. My plastic surgeon says he’ll replace them for $7,000. I do not have that kind of cash. My insurance says, no. The MRI shows they’re encapsulated. What can I do?

    Reply
  • b.elliott February 7, 2012 at 2:04 pm

    Thank you for the understandable and concise discussion of this important issue.

    Reply