What Happens When PIP Breast Implants Break or Leak?

Big fake breasts. Big regrets. Image source: toonpool.com

Does the current ‘global’ scare over French breast implants affect you? Yes, it does affect you, if you are one of 300,000 to 400,000 women in any of the 65 countries whose surgeon used a silicone implant made by the French company Poly Implant Prothese (PIP).

And yes, the issue does affect you if are one of almost 300,000 American women or 1.5 million women worldwide who have had a breast augmentation in 2010, or among the countless more who have had this procedure between 2005 and 2010.

If you are one of these women, you might want to find out if your implant was made by PIP, which offered the world’s cheapest silicone gel implants up until the time it was shuttered in 2010.

Even if you are just mulling over having a boob job, you will still benefit from paying close attention to how the scandal is resolved, and the accompanying discussions on breast implant safety.

If you are one of 230,000 American women or more than one million women worldwide who will develop breast cancer this year, according to health statistics, the issue is also yours, as you may have to undergo a mastectomy and a subsequent breast reconstruction.

The global PIP scare also concerns men as it recently emerged that thousands of contaminated false chests, buttocks—and even testicles for use by prostate cancer victims or those born with only one testicle—were sold by PIP for use by men.

Over the holidays, widespread anxiety over the safety of breast implants made and sold by PIP since 1998 exploded, when French health authorities advised some 30,000 French women to have their implants removed because of their higher tendency to rupture—and offered to cover for the costs.

French authorities made the announcement following the results of an investigation into the PIP breast implants begun in 2010.

All implants can rupture, and all breast implants have a ‘shelf life’ of at most 10 years. But the French probe found that the PIP implants have a higher rupture rate of five percent.

The French Health Products Safety Agency (Afssaps) says it has registered 1,143 ruptures and 495 inflammatory reactions from the implants. Mechanical testing by French authorities has also shown the implant covers to have an increased risk of rupturing.

The inquiry also found that since 2005, PIP implants were made using non-medical grade silicone gel—different from the kind it used to get the approval of French health authorities. PIP even stopped using a protective barrier in its implants.

The silicone gel breast implants approved by the United States Food and Drug Agency and other global health regulation agencies are made of medical grade material that has passed safety tests for human use. The silicone gel in PIP implants was made from material intended for use in mattresses.

The PIP products were banned in France, the United Kingdom, Czechoslovakia and many other European countries in 2010 when news that industrial grade silicone was used in the fillers first broke.

A chemical analysis done for the French radio station RTL showed that the PIP implants also contained a fuel additive called Baysilone, normally used by the oil or rubber industries.

André Picot, the toxicologist who conducted the analysis said this material, as well the industrial silicones Silopren and Rhodorsil, had caused the PIP silicone gel implants to rupture at a higher rate. PIP denied the report, saying Baysilone was not industrial but a food product used in lipstick.

But tests run by the French government have not shown any increased risk of toxicity from PIP fillers compared to normal implants.

And while one of a rare form of cancer called anaplastic large cell lymphoma (ALCL) was recently reported in France in a woman who had a PIP implant, global health authorities have stated categorically that there is no increased risk of acquiring breast cancer from having a PIP implant.

Instead, all women with breast implants—whether saline or silicone gel-filled—have a small but increased risk of cancer, French and US experts say. In January 2011, the FDA announced a possible association between breast implants and ALCL in the scar capsule adjacent to the implant.

What happens when an implant breaks?
But a ruptured silicone implant can be painful and leaking silicone in the body can cause health problems.

When a silicone implant breaks, silicone gel will leak. Leaking silicone can be contained in the thick layer of scar tissue that naturally builds up around the implant and silicone will stay within that scar tissue capsule, causing fibromyalgia (a painful disorder), pain, irritation and inflammation.

According to the FDA’s research, women with leaking silicone implants are more likely to report fibromyalgia or several other painful and debilitating diseases.

If the rupture isn’t addressed, the scar tissue can lead to pain and changes in breast shape, but there’s no scientific evidence that ruptured silicone implants cause serious, long-term health problems like breast cancer or connective tissue diseases.

Sometimes silicone gel can leak outside of the scar tissue capsule and migrate to other parts of the body, including the lymph nodes under the arm and major organs like the lungs where it is impossible to remove.

Some women will not notice anything at all and doctors say there is no evidence of an increased cancer risk—but this is for tested silicone gel approved by global health agencies. With the PIP implants, there is an unknown health potential risk from using the non-medical grade silicone, French authorities also point out.

And when a woman does not know that her implant has ruptured, she increases the chance that silicone will travel in her body, causing more health problems. It can also be more difficult to remove an implant once it has ruptured.

Dr. Sandhya Pruthi says, in an article for WedMD, that most women have no signs or symptoms when a silicone breast implant ruptures. However, some women may experience:

• Pain, burning, tingling, swelling, numbness or redness in the affected breast
• Hard knots or lumps surrounding the implant or in the armpit
• Change in breast size or distorted breast shape
• Softening or hardening of the breast

But removing a breast implant is more complicated than having it put it. Removal of an intact implant is generally not recommended because of the risks involved in having surgery, such as infection, bleeding, and reaction to the anesthesia.

Global scare spreads to U.K.
Because PIP is believed to have sold 300,000 to 400,000 implants to 65 countries over the last 12 years, the scare quickly became global, particularly in countries that had gobbled up the implants. South America accounted for more than half the exports, but a huge chunk of PIP breast implant sales also went to Europe.

In South America, exports went to Venezuela, Colombia, Argentina and Chile. In Brazil, some 25,000 women are believed to have had the implants, the AFP news agency reports.

The Venezuelan government has since offered to cover the costs of removing the implants at the center of the scare, but said it would not pay for replacements.

Columbia has also said it will pay for the removal of flawed implants, in cases where these have ruptured and caused a medical emergency, or when a doctor recommends removal. Some 15,000 women have PIP implants in this Andean nation.

The PIP implants were banned in South American countries such as Brazil, Argentina and Colombia in 2010.

In Argentina, the number of women who have received PIP implants is unknown, but about 13,500 of them were imported from 2007 to April 2010, and today 50 women are suing plastic surgeons who used these items to force them to replace these, Reuters reported.

In Brazil, the world’s cosmetic surgery capital where 200,000 and 300,000 breast augmentation surgeries are carried out every a year, more than 25,000 PIP units were used, the Brazilian Plastic Surgery Society says.

After issuing inconsistent advice over the holidays, the United Kingdom finally agreed to pay for the removal of PIP breast implants from 3,000 British breast cancer survivor-women who had had a breast implant surgery at the National Health Service as part of reconstruction after partial or complete mastectomy. NHS does not perform cosmetic surgery.

Like in Columbia, British health authorities also cleared the way for up to 47,000 private patients to have the PIP implants removed at taxpayers’ expense if there is a clinical need.

Europe was a major market for PIP breast implants, which used to be one of the cheapest before the company was closed in 2010 after reports of its use of substandard silicone fillers hogged the headlines.

In addition to the UK, Spain, Italy, Germany and Ukraine are known to have imported PIP silicon sacs, and Czechoslovakia’s health authorities have recommended that about 2,000 Czech women with PIP implants should have them replaced.

After a review of data used to assess the risk of PIP implant leaking, UK’s Health Secretary Andrew Lansley said there was no evidence to recommend routine removal. But he said private clinics had a “moral duty” to take them out and if they would not, the NHS would step in.

As early as June 2010, the British Association of Aesthetic Plastic Surgeons (BAAPS) advised women who had PIP implants to have a medical checkup within the next six months and to remove these if an ultrasound found weakening or rupture.

Early in the month, a surgeon advising the British government, Dr. Tim Goodacre, recommended the removal of the implants on a “staged basis” but stressed that the failure rate was “quite out of the ordinary.”

Speaking on the BBC’s The World at One on Jan.2, Goodacre, who is president of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) and a member of a panel that probed the products made by French firm PIP, reassured women that he did not think there was any risk of cancer as a result of the faulty implants.

“Good implants put in by reputable people have an extraordinarily low failure rate, so this is something quite out of the ordinary,” he said.

“These implants have been in for a while and there is no immediate cause for concern, there’s no cancer risk, and even if implant gels have ruptured, there’s no evidence to suggest that that in itself is of any major health detriment.”

“But given the fact there is a degree of uncertainty and a lack of knowledge, we’re recommending all implants come out.”

While the UK government was initially inconsistent with its handling of the implant scare, it did order on Dec. 31 a government review of data used to assess the risks posed by faulty breast implants.

Health Secretary Andrew Lansley has said he ordered the review after private clinic Transform came out with new data showing a higher failure rate than it had previously reported.

The review was meant to probe conflicting data on how many PIP breast implants have ruptured in Britain, as the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) relies on data from private providers who are those who carry out cosmetic procedures.

The MHRA has previously indicated that its data suggests the risk of rupture is only one percent, rather than the five percent estimated in France. In new data, private clinic Transform had upped the percentage to sever percent from one to two percent. Britain’s health secretary has since ordered private U.K. clinics to supply the correct data.

At least 250 British women are taking legal action against the clinics that treated them, BBC reports.

Former Miss Great Britain Gemma Garrett, whose PIP breast implants ruptured, has warned women to “think twice” about having similar cosmetic surgery. She told BBC that she had to have her breast implants removed in May.

Meanwhile, PIP founder, Jean-Claude Mas, told police that victims had only filed complaints “to make money.” Mas, who is facing two separate French police investigations for manslaughter and fraud, as well as a slew of criminal charges around the world, is currently in hiding.

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