Posts Tagged PIP implants

Reader Question: PIP Saline Implant Rupture / Years of US Marketing

Posted by admin in plastic surgery news on February 22, 2012

Reader Laura’s Comment:
“I am wondering what the true time frame was that PIP was allowed to market their product in the US. It is my understanding from all that I have read-the FDA strongly recommended that PIP send 2 separate letters to more than 1000 doctors to have the pre-filled implants returned (May 2000 time frame) However I received a pair of PIP pre-filled implants in April of 2002. My right implant ruptured less than 2 weeks ago, and once the rupture happened only then did I learn of all the trouble that PIP has had in the last few years. Contrary to your situation with the patient and having her sign a waiver, my doctor said the PIP were be the best option for me
and he really offered nothing else.”

As early as 2000, U.S. health authorities raised concerns about the French breast implant maker at the heart of a scandal affecting hundreds of thousands of women worldwide. That was almost 10 years before the company came under scrutiny from European regulators. One panel member, Boyd Burkhardt, a plastic surgeon from Arizona, said the company’s data was incomplete, and he found it difficult to understand why the company was “as ill prepared as you appear to be” to meet regulatory standards. Asked to comment on the PIP controversy, Burkhardt, in a brief interview, said that he stands by the prior comments he made to the FDA. It was not immediately clear why after the panel’s rejection the FDA then carried out an inspection of the PIP plant in May 2000. PIP said it stopped selling its saline implants in the United States that same month, according to an SEC filing.

Source: health.yahoo.net/news/s/nm/insight-fda-warned-pip-on-breast-implant-safety-in-2000

I am not quite sure what to tell you. According to the information I was able to find online, the PIP saline implants were pulled from the US market in 2000. From what I remember of the few pairs I handled, they did tend to rupture early. That’s why I stopped using them far before the FDA acted.

Needless to say you need your ruptured implant (or better both of them) removed. The FDA did not make any formal requirements regarding contracting PIP saline implant patients that I can recall. You are actually lucky these implants lasted as long as they did.

It was not standard for doctors to have patients sign statements about PIP implants back in the day. I did that because I felt they were poor quality back then. I was right. :)

Best Regards,

John Di Saia MD

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Australian Therapeutic Goods Association Full Of Idiots

Posted by admin in plastic surgery news on February 13, 2012

Senator Xenophon says he will move in the Senate on Wednesday for the community affairs committee to reconvene its hearing on the TGA. “Clearly there are very serious questions as to whether the actions of the TGA were appropriate and timely,” he said. “Potentially there are 4500 women in Australia with these implants.” Between 300,000 and 400,000 women in 65 countries are believed to have implants made with substandard silicon gel by the French company Poly Implant Protheses (PIP). The TGA has recommended against routine removal of these implants on the basis that there is no evidence of an increased rupture rate.

Source: news.com.au/national/independent-senator-nick-xenophon-
wants-breast-implant-inquiry/story-e6frfkvr-1226262982941

What are these guys in the TGA thinking? They obviously don’t know much about the implants about which they speak.

All silicone gel implants leak to an extent. It is called leeching. So it doesn’t even matter if these implants are ruptured. They still leak. And in the case of the PIP product, the gel inside there is low grade and contains even more than the usual amount of toxins.

My recommendation to all PIP implant patients: “Get them out.”

My recommendation to Australia: “Re-staff your TGA.”

Best Regards,

John Di Saia MD

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Reader Laura with Comment on Reuters Piece on PIP Scandal

Posted by admin in plastic surgery news on February 6, 2012

Reader Laura’s Comment:

“Reuters has an in depth story on the PIP scandal. They talk further on what exactly was in the silicone that their breast implants were filled with. It’s scary that they used unscientific product quality tests that included judging silicone gel by sticking a finger in it. Silopren, Baysilone, and Rhodorsil 47V1000 were used in the making of the homemade silicone gel used in the implants. What kind of long term health issues do these women face in the years to come even after having the implants removed? If one of these implants ruptured do you think they’d be able to find and remove all of the gel? This gel supposedly secreted silicone oil. Is there any way to eliminate that from your body?”

First of all all Silicone gel implants leech (or microscopically leak) silicone gel. This is amongst my reasons for preferring saline implants. No gel. No leak. Much less worry.

When removing older generation silicone gel implants, the gel does get everywhere. This is the best feature of the newer Cohesive silicone gel technology. The gel in these newer “Gummy Bear” breast implants is a semi-solid jello. It should be easier to remove and supposedly leaks less into the body. They still leach silicone though. The significance of this difference in women has yet to be established. They have not been in long enough yet. If you must have silicone gel, I currently recommend these gummy bears. I figure they are likely less harmful.

PIP’s approach to filling these implants was novel. On paper, the company said it used NuSil, a silicone blend made by a California company of the same name, which can be used in medical applications, including implantable devices. NuSil was founded by PIP’s former U.S. distributor, Donald McGhan, who is now in prison in Texas for an unrelated fraud conviction. The company has declined any comment on the PIP affair. But in reality, PIP was mostly using Mas’ own non-approved PIP gel, which looked and felt exactly like NuSil, but cost a seventh of the price.
Source: reuters.com/article/2012/02/02/us-breast-implants-
mas-idUSTRE8110WY20120202

PIP breast implants were made cheaply. That was evidently the main goal in their design. It frequently surprises me that people expect cheap things to work as well as expensive things. The compounds in the implants are not well tested in humans. It is not clear what they will do over time in the women’s bodies in which they have come to reside. And it is not possible to get all the silicone gel out of a woman’s body when removing old silicone gel breast implants.

Saline implants anyone?

Best Regards,

John Di Saia MD

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Reader Laura on PIP Breast Implants and Breast Implant Insurance

Posted by admin in plastic surgery news on January 24, 2012

Reader Laura’s Comment:

“After the PIP scandal there is some talk in England about offering insurance for breast implants. I guess that some women were able to get the NHS (England’s health system) to pay for their implants rather than having to pay for them themselves but there are others who paid for them themselves. The NHS is covering the cost of having the PIP implants replaced that they paid for in the first place but not for those that didn’t go through the NHS. There is also the issue that some clinics where the women paid for their implants themselves are refusing to replace the implants for free or are no longer in business. What protections are in place in the US for women if something like the PIP scandal happens here?”

An insurance scheme for cosmetic surgery patients could be introduced in the wake of the breast implant scandal. Professor Sir Bruce Keogh, who is leading a government review into the risks from faulty breast implants said the scheme would protect consumers. He said today that he favours a protection fund, paid for by the industry, that could be drawn on if the industry hits trouble or another major scandal erupts. However, there are fears that cosmetic surgery companies will simply pass the costs on to patients, in the form of higher bills for treatments.
Source: dailymail.co.uk/health/article-2089377/Cosmetic-surgery-
insurance-introduced-wake-breast-implants-scandal.html

PIP breast implants were made cheaply. Then again they were sold at a lower cost than their competitors. Why should their competitors be forced to pay insurance premiums for problems with faulty products made by someone else?

Breast implants are used for cosmetic and reconstructive purposes. Here in the US, insurers routinely pay for problems in cases in which the reasons for implantation were reconstructive. This is less commonly the case for implants placed for cosmetic purposes. The insurance industry also actively seeks to exclude insuring women who have breast implants. Some health insurance policies specifically exclude conditions arising from breast implant problems.

Your other question was concerning the doctors who placed the implants: Why should they operate free of charge to correct problems with implants that were approved at the time they used them?

The faulty implants are the fault of the company that made them. Expecting implant companies to not pass the cost of any additional insurance to their customers in pretty naive. Businesses do this. Pretty much only doctors are restricted from usual business practices like this…in many cases anyway. Doctors are lousy businessmen.

Issues of insurance in plastic surgery are usually complicated. When taken as a whole they become hard to administer fairly.

Best Regards,

John Di Saia MD

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Reader Laura on PIP Implant Lawsuits

Posted by admin in plastic surgery news on August 5, 2011

Reader Comment:
“What do you think the future of these patients will be? Will they be able to get saline implants now and/or reconstructive surgery? What health risks are there with the silicone still being in their body? Will they have to have multiple surgeries to remove all of the silicone?”

A children’s nanny whose breast implants split is one of more than 165 women preparing legal action against the French company that made them. Sarah Neale, 29, spent more than £4,400 seven years ago having her breasts enlarged from a 32B cup to a 32DD. But, two years ago, she was horrified when she found that gel had seeped out, leaving silicone lumps in nearby tissue.
Source: dailymail.co.uk/health/article-1325948/Nanny-sues-French-company-breast-implants-split.html

All silicone gel implants leak to an extent. The Poly Implant Prothese (or PIP) implants have been found to leak more and reportedly contain a poor grade silicone. Silicone leakage within the body can cause problems requiring surgery to remove scar, calcium and gel remnants. It is usually not possible to remove all the gel and reactive change, but most can usually be removed. Few women will require multiple operations and more involved reconstruction. Some will have some residual deformity depending upon how little healthy tissue they have left when the implants and scar are taken out. It is debatable as to what may be the effects of the silicone that remains in the body. This also varies.

Interesting in the PIP implant debacle is the fact that these implants were the cheapest and therefore were widely used for a time. The difference in cost for the saline PIP implants that used to be marketed here in the US was very small compared to their US made counterparts. I used a few pairs years ago and stopped even before they were removed from the US market. I didn’t think it was worth the risk.

Best Regards,

John Di Saia MD

Originally posted 2010-11-30 07:30:27.

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French PIP Breast Implant Company Closed Down

Posted by admin in plastic surgery news on May 18, 2011

The OC Register “In Your Face” Blog posted on a French Breast Implant Maker Shutdown:

DRAGUIGNAN, France (AFP) – A French court Tuesday ordered the closure of a company making breast implants after health authorities ordered a recall of its products for using non-authorized silicone gel.

The Poly Implant Prothese (PIP) company is alleged to have made the implants fraudulently using unsanctioned silicone gel.

The agency that oversees health care products here, the AFSSAPS, also ordered a ban on new sales of the implants.

Around 90 percent of PIP’s breast implants are exported.

Source: health.yahoo.com/news/afp/francewomenhealthsiliconecrime_20100330201426.html

PIP (Poly Implant Prothese) did used to market here in the United States, but only their saline-filled implants. They lost their permission to market certificate here in the US a few years ago. We are still taking them out of patients however. I removed a pair the other day. Their saline implants had a high rupture rate.

Best Regards,

John Di Saia MD

Originally posted 2010-04-12 09:00:42.

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