30,000 French Women Received Defective Breast Implants

Princess 19 on 20 Dec 2011 at 4:00pm

Over 30,000 European woman have discovered they received defective breast implants filled with industrial grade silicone (a potentially lethal poison) vs. safe medical grade silicone.

The breast implants in question were made by a French company called Poly Implant Prosthesis (PIP).  An investigation last year uncovered cost-cutting measures that had the manufacturers making implants with weak exterior cases filled with silicone traditionally used to manufacture computer parts or mattresses.  The cheaper models were likely to rupture or leak into the body causing irreparable harm.  The company has since closed. 

There are more than 2,000 women in France with pending lawsuits against the company. There are four confirmed patients with cancer that had received the implants.  Two of those women have died.  One of those women was 53-year-old Edwige Ligoneche (below).  She recently died of malignant lymphoma, which developed in the breast’s capsular scar tissue – close to where her implant ruptured. 

Her death prompted a manslaughter case against the company, as well as further investigation for the other women with pending lawsuits. Ms. Ligoneche’s family went so far as to demand that victims receive compensation and free corrective surgery.

53-year-old victim Edwige Ligoneche

Defective implants were also used and sold in other countries such as the UK, Spain, Belgium, and Holland.  Women all over Europe are now being informed to visit their doctors, regularly check for leaks or breaks, and if possible, have them replaced by safe models. 

Just today ABC News reported that "French Government spokeswoman Valerie Pecresse, a member of a special committee formed to investigate the issue, highly recommended that "all women who have PIP implants should return to see their surgeons urgently."

Many patients could have possibly received the faulty implants if they traveled to these countries to have their procedure done to save money – a potentially detrimental mistake. 

“We reiterate our advice and extend this to women who may have gone abroad for their surgery: contact your clinic to find out what type of implant you have,” says Fazel Fatah, president of the British Association of Aesthetic Plastic Surgeons.

Should U.S. women worry about the implants manufactured stateside?

Not so, says one doctor.

“I think the most important point of distinction between regulatory in Europe and the US is the tremendous amount of safety data required by the FDA before submission for a product for clearance - as well as the ongoing oversight that the FDA performs post approval,” says New York City plastic surgeon, Z. Paul Lorenc, MD.

“This involves not only post-market approval clinical data but also site visits of the manufacturing plants,” he added.

“We have heard that PIP implants may still be used in some Eastern European countries, and this should serve as a warning to any woman considering breast augmentation to make sure she is getting implants from a reputable company that has the required safety data and stands behind their products,” says Wendy Lewis, a global consultant on plastic surgery known also as, The Knife Coach.

“However, the PIP situation should not taint the entire breast implant industry at large,” she concluded.
Let's hope this tragedy was isolated within PIP, and an incident like this will never happen again.

Photo credit:  stephaniefranklin25 on flickr; Daily Mail