Ep 55 Breast Implant Recalls
Engineering News – Regenerative Bone Tissue (0:50)
This week's engineering failure is PIP Breast Implants (3:05); our first medical engineering failure. In an effort to cut costs, PIP cut corners on the silicone (8:10) in their implants that led to severe problems for recipients starting in 2003 (20:15).
PIP Breast Implant Comparison After Implantation
Sources:
Engineering News
Breast Implant Recalls
Episode Summary
Hi and welcome to Failurology; a podcast about engineering failures. I’m your host, Nicole
And I’m Brian. And we’re both from Calgary, AB.
Thank you again to our Patreon subscribers! For less than the cost of a not boring footlong sub at Subway, you can hear us talk about more interesting engineering failures!
This week in engineering news, regenerative bone tissue.
Researchers at Texas A&M University are using new nanotechnology to direct stem cells to form bone tissue.
They developed a water stable 2-D covalent organic framework (COF) which are porous organic polymers, to direct the differentiation of human stem cells into bone cells.
Previously, these organic polymers were difficult to process into nanosized materials which was limiting their application in regenerative medicine and drug delivery.
They were able to use the 2D polymers to exhibit bioactivity and direct stem cells to bone cells, even using the shape and size to impart the bioactivities.
So in Harry Potter they can regrow bone and I always thought that would be really cool. Also, in Bones a bone donor was riddled with cancer and spread it to all of his recipients which was really sad.
If you want to read more about the study, check out the link on the web page for this episode at failurology.ca
Now on to this week’s engineering failure; our first bioengineering failure, breast implant recalls.
I just want to say that I’ve wanted to do a biomedical type engineering failure for a long time, probably since close to the beginning of this show. But there were a couple things holding me back.
Firstly, as much as I say I’m not a structural engineer or not a nuclear physicist, I'm really not a biologist. I completely respect the work that all biological sciences are doing, it’s just not an area of interest for me. And I can tell that because no matter how many times I look at human anatomy, I still can’t remember where most organs are located. I track my interests based on things I can’t stop thinking about and biology is rarely something I think about non stop. Nonetheless, I think bio engineering failures have a very real place on this show and I think they are often overlooked or put into a different category, but they are still engineering, they are very interesting, and I think they can often have a wider impact than a single failure event.
Second challenge was that looking at some of the bio engineering failures, they are not the most appealing sounding topics. While a transvaginal bladder sling might be interesting and is honestly an abhorrent sounding, very real problem that a lot of people are dealing with, I don’t think I’m comfortable enough with covering these types of failures so start there. Maybe I will work up to it, baby steps. So finding a topic that was interesting, important and appropriate was a bit of a challenge.
Then how, do you ask, did we land on breast implants? Well, I think breast implants often get a bad rap. They can be seen as superficial, or vain or shallow. But they have very important and impactful real world applications. Women suffering from breast cancer who need a full mastectomy will sometimes get breast implants. Trans women who want to feel more comfortable in their own body may get breast implants; and this is often a really big life changing and life saving surgery for them. And then there are women who just aren’t comfortable with the breasts they were given and they want to make a change. I’m sure there are more applications but I would say these are most common.
Also want to mention, there is a syndrome called breast implant illness; this episode is different. We are going to talk about defective implants that surpassed the regulators.
What happens when the breast implants go horribly awry. Well, let’s get into it.
Poly Implant Prothèse/Prosthesis (PIP) was a French company founded in 1991 by two Frenchmen. The first was a former butcher and later mechanical sales representative, and the second was a plastic surgeon who introduced breast implants to France in 1965. When the latter died in a plane crash, the former went on to launch PIP in 1991.
PIP produced silicone gel breast implants until 2010 after it was discovered they had been illegally manufacturing and selling implants made from cheaper grade industrial silicone since 2001. Even though medical grade silicone had been mandated.
These cheaper grade silicone implants had a 500% higher risk of rupturing or leaking and caused several deaths from system toxicity and induced breast cancer.
When the implants ruptured or leaked they caused inflammation and irritation, but the impure gel is also a toxic substance that isn’t supposed to be inside of the human body and it created additional side effects.
Poly Implant Prothse didn’t start out that way though. Up to 2000, they were following regulations and catering to a large market. But then the FDA, which is the US Food and Drug Administration, banned the use of silicone implants in the US market. This greatly impacted PIP’s sales and they had to find a way to either generate more sales or cut costs.
The owner of PIP decided to switch out the expensive medical grade silicone for in house produced industrial grade silicone. This translated into a 90% savings, which is obviously very significant. But at what cost? It doesn’t appear that regulators were aware of the change, PIP just assumed the change would be accepted and so they never applied.
And part of me thinks, well why would they ask if they didn’t know they needed to? And part of me wonders how no one realized?
Also interesting, PIP still made the high quality implants with the correct silicone, but it was 5x the cost of the industrial grade silicone implant.
It seems weird that no one questioned the price difference. Although perhaps they are marketing to different doctors, if someone says I have this one thing that costs 5x more than the other, but they are the same, don’t you wonder why?
Problems started coming in 2003. Tracking the data is a bit challenging, but from the available data, the evidence suggests that
PIP implants had a failure rate of at least 6% after 5 years with estimates up to 12%. And a failure rate of at least 14% after 10 years with estimates as high as 30%.
Other symptoms include lumps around the implant or in the under-arm, inflammation in the breast tissue and hardening of the breast, generalised pain, respiratory problems, anxiety, and fatigue.
In 2009, France surgeons reported abnormally high rupture rates and there were a flood of legal complaints and PIP filed for bankruptcy. Around this time, their quality certificate was also pulled and PIP’s implants were recalled. They were the third largest maker of breast implants in the world, so you can imagine the impact.
Now, you're probably wondering why no one noticed the silicone change for almost a decade. One of the former PIP workers said “you had to have been a chemist to notice anything.” To everyone else, the silicone looked the same as the medical grade stuff. The cheaper silicone used Baysilone, Silopren and Rhodorsil which are chemicals commonly found in field additives or in industrial rubber tubing. They mixed these products with 75% of the industrial silicone and 25% of the medical grade silicone to further disguise the silicone change. An inspection of the manufacturing site found that PIP had been using unapproved industrial grade silicone for 10% the cost of the original, medical grade silicone.
In 2011 a woman with a PIP implant developed scar tissue, which was common with implants, but her scar tissue developed a rare form of cancer and unfortunately she passed away. This finally forced the French government to do something and they recommended 30,000 women in France get their PIP implants removed. France covered the removal, but only covered the replacement where the implants were medically required and everyone else had to finance themselves. Which is really not enough for France. They permitted thousands of these implants to be put in, without proper manufacturing oversight. Ireland was a lot better, they paid for removal of the implants. Several other countries recommended that recipients meet with their doctors to see how much of a risk the implants are. Some paid for removal, some didn’t.
I think it’s important to note that there are risks with removing or replacing the implants. It’s a fairly major surgery, anaesthesia is always a risk, complications, infection, and issues with recovery.
In 2013, the owner was charged along with the deputy, quality director, technical director, and products chief. The owner was sent to prison for four years.
In 2021, not that long ago, the company that had provided the quality certificate was found negligent and partially liable for damages. They had argued that PIP removed evidence of the industrial silicone gel before they did the annual inspections. Courts ruled they still should have detected the fraud.
The owner’s son tried to restart the company and re-open the factory to produce 400 implants a day to export to the European, South America and Chinese Markets. But luckily that whole thing fell apart after media coverage.
So there you have it, the PIP breast implant failure. Cutting costs by using non medical grade silicone puts thousands of women’s lives at risk. This failure highlights regulatory and quality control shortcomings that need to be addressed in the world of plastic surgery.
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Bye everyone, talk soon!