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60 Minutes Report: Media Coverage Wrap-up
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Did Boston Scientific Use Counterfeit Plastic in Pelvic Mesh?
| Medical Device and Diagnostic Industry
By Amanda Pedersen
Vaginal mesh problems are back in the spotlight this week after a scathing 60 Minutes report claimed the company knowingly bought counterfeit plastic materials from a Chinese supplier to produce the devices. -
Gynecological mesh: The medical device that has 100,000 women suing
| CBS News
There is tremendous controversy about a surgical device implanted in more than two million American women. -
60 Minutes: Boston Scientific Vaginal Mesh Unfit for Humans
| Drugwatch
By Michelle Llamas
Boston Scientific knowingly used unstable plastic in its vaginal mesh implants. -
Boston Scientific down 2% premarket after critical 60 minutes report
| Seeking Alpha
By Douglas W. House
Boston Scientific (NYSE:BSX) slips 2% premarket on light volume on the heels of last night's 60 Minutes report on its gynecological mesh product, the target of product liability lawsuits from 48K plaintiffs. -
’60 Minutes’ Shines Harsh Light on Boston Scientific’s Gynecological Mesh
| Investor Place
By William White
A recent look at Boston Scientific Corporation’s (NYSE:BSX) gynecological mesh paints the company in a negative light. -
Boston Scientific faces 48k lawsuits over pelvic mesh implants: 5 things to know
| Becker's Hospital Review
By Mackenzie Bean
Boston Scientific is involved in tens of thousands of lawsuits filed by women who experienced health complications related to the devicemaker's gynecological mesh implants, according to a "60 Minutes" report aired May 13. -
‘60 Minutes’ looks at lawsuits against Boston Scientific
| Boston Globe
By J.D. Capelouto
Boston Scientific, a Marlborough-based company and one of the largest manufacturers of a gynecological mesh implant, has been the subject of more than 48,000 lawsuits from over 100,000 women alleging that the plastic strip inflicts serious pain and injury, “60 Minutes” reported Sunday night. -
'It felt like a cheese grater inside of me;' More than 48,000 lawsuits filed against Boston Scientific for pelvic mesh implants
| Mass Live
By Michelle Williams
A medical device manufacturer based in Massachusetts is facing tens of thousands of lawsuits from women. -
Boston Scientific besieged by lawsuits over gynecological mesh implants amid 60 Minutes report
| Proactive Investors
This marks the biggest litigation movement since lawsuits against asbestos manufacturers. -
60 Minutes report claims unapproved plastic sources used in Boston Scientific pelvic meshes
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Online Sources
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Did Boston Scientific Use Counterfeit Plastic in Pelvic Mesh?
| Medical Device and Diagnostic Industry
By Amanda Pedersen
Vaginal mesh problems are back in the spotlight this week after a scathing 60 Minutes report claimed the company knowingly bought counterfeit plastic materials from a Chinese supplier to produce the devices. Boston Scientific says the claims are "completely false" and based on outdated and previously disproven allegations. Companies that sell implantable transvaginal mesh devices have been fighting massive, multi-district litigation for years as thousands of U.S. women have complained of severe complications after surgery. Now, a scathing 60 Minutes report on the issue has Boston Scientific up in arms.
CBS aired the 60 Minutes report Sunday evening, uncovering emails that suggest Marlborough, MA-based Boston Scientific knowingly bought counterfeit plastic material from a Chinese supplier to produce the devices and even repackaged the material to hide the fact that it was an imitation product. The show's producers said Boston Scientific declined an interview with 60 Minutes, but the company responded to the claims in a statement issued shortly after the segment aired. The investigative story contained "completely false claims that our transvaginal mesh products contain counterfeited and smuggled materials," according to the company's statement, which is signed by CEO Mike Mahoney, and Dave Pierce, president of Boston Scientific's urology and pelvic health division. Vaginal mesh implants made of polypropylene, a type of plastic commonly used in packaging.
Boston Scientific originally bought a brand of polypropylene called Marlex from a Texas-based subsidiary of Chevron Phillips. But in 2005, Chevron Phillips stopped selling Marlex to Boston Scientific out of concern that the material should not be used in medical applications involving permanent implantation into the human body.
"Later, when Boston Scientific appealed, Chevron Phillips replied 'we are simply not interested in this business at any price'," 60 Minutes reported.
That put the company in a bind because FDA approval of its transvaginal mesh products was based on the use of Marlex to produce the devices. In 2010, a second supplier refused to sell polypropylene for use in medical devices.
"Boston Scientific's global sourcing division decided to use a middleman with no direct link to Boston Scientific so the plastic makers wouldn't know the true buyer," the 60 Minutes producers said in their report. "But that plan failed."
As MD+DI previously reported, a 2016 lawsuit alleged that Boston Scientific ended up smuggling a counterfeit version of Marlex from China, but a federal judge gave FDA jurisdiction over that case.
That supplier was a Guanghzou, China-based company called Emai Plastic Raw Materials. According to the 60 Minutes segment, Emai told Boston Scientific it had "tons" of Marlex imported from Chevron Phillips in Texas.
"Boston Scientific's man in China wrote his superiors, 'Do we need to ask Emai if this material is supposed to be used in medical implantables?' Boston Scientific's director of materials management replied, 'Please don't tell them where we will use it, it could scare them away'," 60 Minutes said, citing court documents.
Boston Scientific's own quality assurance procedures required documentation that Emai's product was indeed Marlex from Chevron Phillips. But Emai did not have the required documentation to verify authenticity. The company reportedly checked the lot numbers on the bags it purchased from Emai and confirmed with Chevron Phillips that the numbers were fraudulent and that even the packaging was fake.
Further investigation by Boston Scientific included a test analyzing 11 parameters to compare the Marlex obtained directly from Chevron Phillips to the Emai-sourced Marlex, according to 60 Minutes. Only two parameters were the same, and of the nine that were different, four of those parameters read as "very different."
And yet, Boston Scientific concluded the two materials were the same and proceeded to buy enough of the Emai-sourced plastic to last 30 years, the news program revealed.
"The broadcast resurfaced outdated and previously disproven allegations first made by attorneys in 2016," Boston Scientific said in its statement. "Our rigorous testing and investigation have shown that the resin currently used in our products matches a formulation from the original U.S.-produced resin."
The company said FDA also reviewed the information and drew the same conclusions.
The 60 Minutes report also suggested that Boston Scientific decided to hide the counterfeited packaging from customs officials by "over bagging" the product in plain wrappers. Then, on its customs declarations forms, Boston Scientific told Chinese customs officials the plastic was made in China, and told U.S. customs officials the plastic was made in Texas.
Boston Scientific denied these allegations and said the documents and photos shown during the 60 Minutes segment were taken out of context.
"Numerous communications not shown by 60 Minutes demonstrated that our employees were committed to making sure that we complied with all import and export regulations in shipping the resin to the U.S. The steps taken by Boston Scientific depicted in this segment were inaccurate," the company said. "We packaged the materials to prevent them from damage during transportation. This was well-documented and would not have prevented customs officials from opening or further inspecting the bags."
Boston Scientific said the 60 Minutes segment offered a one-sided view and commentary from clinicians and plastic experts who have been involved in lawsuits against the company.
"It is important to keep in mind that polypropylene-based (plastic) devices have been a mainstay in many medical procedures for more than 50 years, including hernia and tendon repair, sutures, and wound closure," the company said. "Furthermore, our products meet rigorous internal safety standards, international standards, as well the standards of the FDA and other regulatory bodies. Leading physician societies have issued supporting statements on mesh, and the American Urogynecologic Society recently shared its perspective."
These products are used to treat women with pelvic floor disorders, and Boston Scientific said its transvaginal mesh products have been used to successfully treat nearly 1 million women.
"Our mesh products contribute to only 1% of annual sales to our company. Continuing to provide these mesh products is not about profits. It is about doing what is right for patients," according to Boston Scientific. "Without these products, women would be left with few treatment options for these debilitating and often embarrassing conditions."
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Gynecological mesh: The medical device that has 100,000 women suing
| CBS News
There is tremendous controversy about a surgical device implanted in more than two million American women. It's a strip of plastic called gynecological mesh. The manufacturers and several medical societies say the implant is safe. But more than 100,000 women are suing. And together, they make up the largest multi-district litigation since asbestos. One of the largest manufacturers of gynecological mesh is Boston Scientific, a medical device maker with $9 billion in sales. Millions of patients benefit from its pacemakers, stents and other devices. But Boston Scientific has attracted 48,000 lawsuits which claim that its mesh can inflict life-altering pain and injury. Surgeons use Boston Scientific's gynecological mesh like a sling to relieve urinary incontinence and to lift organs that shift after pregnancy. Gwyn Madsen had a Boston Scientific implant in 2012.
Gwyn Madsen: It felt like a cheese grater inside of me.
Like thousands of others who have filed suit, she says she suffered pain, which in her case, left her hardly able to sit or play with her children.
Gwyn Madsen: It felt like the material was pulling on the muscles and I'd get shooting pains you almost felt like there was something inside of you that was like sandpaper back and forth, every time you'd walk.
Boston Scientific has fought allegations like Gwyn Madsen's for years. They declined an interview for our story but the company told us, "Nearly one million women have been successfully treated… We have extensively tested the [plastic] resin to confirm its composition, safety and performance." The American Urogynecological Society has also said that plastic mesh is "safe and effective." But that's not what many doctors are finding.
Dr. Michael Margolis: The mesh causes a chronic inflammatory reaction.
Dr. Michael Margolis is a surgeon who has removed 350 mesh implants. He's been a witness in lawsuits against Boston Scientific.
Dr. Michael Margolis: The slings I've removed are substantially altered in their architecture. They are shrunk by at least 50% in width; they are encased in scar tissue. The pores here, these openings here are shrunk substantially.
Dr. Margolis recently removed this type of Boston Scientific mesh. It had been implanted in his patient for life, but after two years, it looked like this.
Dr. Michael Margolis: It was folded, it was contracted, it was embedded in scar tissue, it was choking off the urethra. It was 50% the size of its original implant. I measured it, as I always do.
Scott Pelley: These are things that are not supposed to happen?
Dr. Michael Margolis: Of course not. This implant is not supposed to change. The mesh is made of a plastic called polypropylene, a common material in packaging. Boston Scientific had clearance from the FDA to use a brand of polypropylene called "Marlex" made in Texas by a subsidiary of Chevron Phillips. But in 2004, Chevron Phillips became concerned about medical use of Marlex. It issued a warning that it must not be used for "permanent implantation in the human body." Duane Priddy is a leading plastics engineer and a fellow of the American Chemical Society.
Duane Priddy: I can't, in my wildest imagination, imagine anybody that's knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body. It's well known that its oxidatively unstable.
Duane Priddy has been a witness in mesh lawsuits, but he is not part of any litigation against Boston Scientific. He explained to us that oxygen breaks up polypropylene. The plastic has antioxidant additives but they dissipate over time.
Duane Priddy: Once those antioxidants are consumed, they're no longer there to do their job, polypropylene will rapidly disintegrate and fall apart.
Scott Pelley: In layman's terms, oxygen eats plastic.
Duane Priddy: That's correct.
In 2005, Chevron Phillips cut off Boston Scientific's supply of Marlex. Later, when Boston Scientific appealed, Chevron Phillips replied, "We are simply not interested in this business at any price." Boston Scientific estimated that it would run out of Marlex by 2012. George Vialle, director of Global Supply Chain wrote, this plastic resin "supports a $120 million in annual revenue… I can not [sic] overstate the importance of getting more." Boston Scientific had to have Chevron Phillips Marlex because that plastic was already accepted by the FDA.
Chris DeArmitt: They looked everywhere. They looked at least 20 different companies all around the world. They were looking for stocks of material.
Chris DeArmitt is a plastics engineer who researched Boston Scientific for one of the women suing the company.
Chris DeArmitt: they really struggled. There was a big panic on because they had a big stockpile. They ran out. And they realized they were gonna have to source more.
That struggle is revealed in company documents that we found in court records. This report shows, in 2010, a second supplier refused to sell polypropylene "for use in medical device." Boston Scientific's global sourcing division decided to use a middleman with "no direct link to BSC" so the plastic makers wouldn't know the true buyer. But that plan failed.
Chris DeArmitt: They're looking for material and they're desperate. They can't find it locally so they find it in China. And they literally say, "We have to be careful here. Some of these look more credible than other ones." They are not convinced that it's real material.
A broker in China, called Emai, said it had tons of Marlex imported from Chevron Phillips in Texas. Boston Scientific's man in China wrote his superiors, "do we need to ask [Emai] if this material is supposed to be used in medical implantable?" Boston Scientific's director of materials management replied, "please don't tell them where we will use it. It could scare them away."
That same month, the FDA issued a damning report. Over five years, the FDA found that mesh supporting organs after pregnancy, had resulted in nearly 4,000 "reports of injury, death, and malfunction" and complications including "pain, infection, urinary problems, bleeding and organ perforation." "Serious adverse events," the FDA said, "are not rare." Now, Boston Scientific had even more reason to believe that if it switched plastics the FDA would require years of tests which might fail. The company's best hope appeared to be the plastic in China but then came the red flags. Boston Scientific's own procedures required documents and import records that proved that the plastic was Marlex from Texas. But Chinese broker, Emai, didn't have any documents to verify authenticity. Boston Scientific checked the lot numbers on the bags and confirmed through Chevron Phillips, three times, that the numbers were fraudulent. Even the bags were fake. Chevron Phillips says the printing on the counterfeit bag, on the right, is full of errors from the color to the name of the Texas city where Marlex was made. Evidence was mounting that the plastic in China was counterfeit, so Boston Scientific ordered tests to compare it with original Marlex.
Chris DeArmitt: They analyzed 11 different parameters, looking at the two plastics side by side, done, the same tests. Nine of those were different. Two were the same, nine were different. And of those nine that were different, four of those parameters were very different. And somehow, from that, they concluded that it was the same material.
Scott Pelley: How did they come to that conclusion?
Chris DeArmitt: Well, I'm wondering that too. I mean, how can you look at two things side by side and say, "Yes, it's the same stuff."
In an email from the address of Ann Charest, manager for plastics in Boston Scientific's global sourcing division, there's speculation about the Chinese plastic's lack of documents. "It may not have been imported through proper channels" or it may have been "redistributed enough times, the original paperwork has been lost/forgotten…" Facing a deadline, with those test results, no documents and having learned the lot numbers were fake, Charest concludes, "I believe this is the right material." Boston Scientific bought enough of the Chinese plastic to last 30 years. We hired plastics engineer Duane Priddy as an independent consultant to analyze Boston Scientific's own tests of the Chinese plastic. We found the test results in court documents.
Duane Priddy: I would predict a significant difference in the antioxidant stability, or I should say the oxidation resistance of those products in the human body.
Scott Pelley: The Chinese product is inferior?
Duane Priddy: Absolutely. Yes.
Scott Pelley: Is the Chinese product something that you would imagine being placed inside the human body for 20, 30, 40 years.
Duane Priddy: Absolutely not.
Scott Pelley: How long would it likely last?
Duane Priddy: A few months.
Teresa Stevens: I started to have problems right away. I told the doctor while I was in the hospital, I couldn't feel my bladder, I couldn't feel when I had to go.
Teresa Stevens had a Boston Scientific mesh implant in 2014 after the company began using the Chinese plastic.
Teresa Stevens: Sometimes when I went to the doctor, I would have an infection, sometimes when I went I didn't. So, but I was having pain every time I would void. So, a lot of times I would have some blood. So, I knew something was wrong.
In 2016, she had her mesh implant removed by Dr. Michael Margolis who told us the Chinese plastic's lack of documents is a concern. Dr. Michael Margolis: This is an experimental material. Implantation of this into anyone is human experimentation but without consent. Because this is novel material. We don't know how this affects humans, it's never been tested before.
Chris DeArmitt: I would say the material they're buying maybe is fine for making a park bench. Maybe it's fine for making a disposable cup. But that's a totally different situation when you're looking at something that will be in the body for 40 or 50 or 60 years. There's a whole different level of analysis and confidence that you need. And I don't see that here.
Scott Pelley: The FDA requires Boston Scientific and companies like it to understand every step in the supply chain. In other words, who made the material, who packaged it, who shipped it, et cetera. How much did Boston Scientific understand about that supply chain?
Chris DeArmitt: They don't seem to know where the material is coming from. Nobody knows who the original manufacturer is. Nobody knows and that's a big deal, right? You have to take a record of every lot, was it contaminated? Has it been tested? And they don't know any of those, any of those answers.
Boston Scientific also faced hurdles in getting the 16 tons of plastic out of China. The counterfeit bags were labeled "Texas." But, with no import records, Boston Scientific's man in China wrote, "If we don't get rid of the original bags… if it is caught by customs we will be in trouble." A plan to hide the bags in plain wrappers was approved in an email sent from the address of Charles Smith, a director in Boston Scientific's urology and women's health division. "We can over bag." The email reads. Pictures of the overbagging operation were then distributed to many company executives for their approval. On its declarations, Boston Scientific told the Chinese the plastic was made in China. It told U.S. Customs the plastic was made in the U.S. Because of lawsuits by Teresa Stevens, Gwyn Madsen, and thousands of others, the FDA looked into Boston Scientific's experience with the Chinese plastic. The FDA declined an interview but wrote, "We… did not find any indication that the change in [plastic] resin led to an increase in adverse events. We have confidence in our… findings."
Scott Pelley: The FDA recently reviewed these same test results and they said that the Chinese mesh, quote, "does not raise new safety or effectiveness concerns." What do you make of that?
Duane Priddy: That's shocking. It's hard for me to imagine somebody looking at that data and generating an opinion that it is acceptable for use in the human body.
Scott Pelley: Is your analysis something that any other expert in plastics would see immediately?
Duane Priddy: Yes.
Scott Pelley: This is not a close call?
Duane Priddy: No.
As we said, Boston Scientific declined an interview but it wrote, "Any allegations continuing to question the integrity or legitimacy of our [plastic] resin are false and irresponsible." We wondered whether Boston Scientific mesh products still contain the Chinese polypropylene smuggled into the United States, so we purchased 15 Boston Scientific mesh kits and sent them to a leading plastics lab. All of them matched the Chinese plastic.
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60 Minutes: Boston Scientific Vaginal Mesh Unfit for Humans
| Drugwatch
By Michelle Llamas
Boston Scientific knowingly used unstable plastic in its vaginal mesh implants. The implants led to injuries in thousands of women, according to a 60 Minutes report broadcast on May 13, 2018.
Surgeons use Boston Scientific’s mesh implants to treat incontinence and pelvic organ prolapse in women.
The rate of complications caused by transvaginal mesh is so high the U.S. Food and Drug Administration classifies them as Class III devices. This category is for the riskiest devices approved by the agency.
Mesh victim Tammy Jackson has suffered complications from mesh for nearly a decade. She appreciates the 60 Minutes coverage.
Jackson told her mesh story in the upcoming 2018 Netflix documentary called The Bleeding Edge.
“60 Minutes brought some awareness,” Jackson told Drugwatch about the report. “I would have liked to hear more about the complications and deaths of mesh patients. Like being septic, antibiotic resistant, kidney atrophy and kidney stones — all of which I am suffering.”
Jackson is currently in the hospital for mesh complications. She and other women filed lawsuits claiming the implants are defective.
Part of the defect may lie in the plastic used to make the implants, according to experts. Polypropylene Mesh is ‘Unstable’
Manufacturers make the implants from a plastic called polypropylene. Polypropylene is unstable when exposed to oxygen, plastics engineer Duane Priddy told 60 Minutes.
Priddy has testified in lawsuits against Boston Scientific.
“I can’t in my wildest imagination imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body,” Priddy said. “It’s well known that it’s oxidatively unstable.”
Despite concerns from experts, mesh was too profitable for Boston Scientific to stop manufacturing. Boston Scientific Used Counterfeit Chinese Plastic in Mesh
In 2004, plastic maker Chevron Phillips told Boston Scientific it would no longer supply Marlex polypropylene plastic for the implants.
“We are simply not interested in this business at any price,” Chevron Phillips told Boston Scientific.
Injured by complications related to transvaginal mesh?GET A FREE CASE REVIEWMarlex should not be used for “permanent implantation in the human body,” Chevron Phillips warned.
This didn’t stop Boston Scientific from making the implants. Instead, it smuggled counterfeit Marlex plastic from a supplier in China called Emai.
Boston Scientific’s tests found several inconsistencies in the plastics. It used the plastic anyway.
Priddy told 60 Minutes this plastic would only last a few months in the human body.
Dr. Tom Margolis has removed problematic Boston Scientific mesh implants from women. He describes using the Chinese plastic as “human experimentation but without consent.”
“We don’t know how this affects humans,” Margolis told 60 Minutes. “It’s never been tested before.”
Boston Scientific faces lawsuits under the Racketeer Influenced and Corrupt Organizations Act (RICO) over its alleged illegal use of counterfeit plastic. Other Companies Involved in Mesh Controversy
The 60 Minutes report focuses on Boston Scientific. But, a handful of other companies also make vaginal mesh with polypropylene. Companies in lawsuits include Boston Scientific, C.R. Bard and Johnson & Johnson’s Ethicon subsidiary.
C.R. Bard also used Chevron Phillips’ Marlex plastic.
Chevron Phillips also told Bard not to use its plastic for human implantation, according court documents. Mesh lawsuits against Bard say the company tried to cover up its use of Marlex.
At one time, more than 100,000 women filed federal personal injury lawsuits against pelvic mesh makers.
In April 2018, Boston Scientific told investors it put aside $800 million to settle its remaining mesh lawsuits.
Despite thousands of lawsuits over its mesh, Boston Scientific stands by its product.
“Nearly one million women have been successfully treated… We have extensively tested the [plastic] resin to confirm its composition, safety and performance,” the company told 60 Minutes.
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Boston Scientific down 2% premarket after critical 60 minutes report
| Seeking Alpha
By Douglas W. House
Boston Scientific (NYSE:BSX) slips 2% premarket on light volume on the heels of last night's 60 Minutes report on its gynecological mesh product, the target of product liability lawsuits from 48K plaintiffs.
The report, led by Scott Pelley, stated that the company has been using an unapproved source material, a plastic called polypropylene, from China after original produced Chevron Phillips decided to exit the business over concerns with its use in the medical arena. The material alleged degrades quickly in the body causing pain and discomfort.
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’60 Minutes’ Shines Harsh Light on Boston Scientific’s Gynecological Mesh
| Investor Place
By William White
A recent look at Boston Scientific Corporation’s (NYSE:BSX) gynecological mesh paints the company in a negative light. The investigation into the mesh comes in the form of a 60 Minutes piece from CBS. This takes a look at the gynecological mesh, how it has affected women it was placed in, and the 48,000 lawsuits concerning it.
The first bit of bad publicity for Boston Scientific is what has been happening to the gynecological mesh over time. The mesh is meant to last forever, but it appears they are breaking down inside some women. This includes the meshes coming out smaller after surgery to remove them, as well as being covered in scar tissue.
The report then looks at how Boston Scientific makes the gynecological mesh. At first, it was getting the plastic for the mesh from Chevron Phillips subsidiary Marlex. However, the company chose not to sell the plastic to BSX after learning what it was being used for.
With Boston Scientific being unable to get the plastic for its gynecological mesh from Marlex, the company turned to a Chinese supplier. This supplier claimed the two plastics were the same, but tests show the Chinese version is inferior. Despite allegedly knowing this, BSX went ahead and bought the plastic to make its gynecological meshes.
Next up are the complaints from many women that have had it installed following a pregnancy. This includes women that have complained about discomfort, severe pain and other issues that the gynecological mesh causes them.
As a result of all these issues, Boston Scientific now faces 48,000 lawsuits over its gynecological mesh. These lawsuits have more than 100,000 women taking the company to court over issues they’ve had with the product.
As of this writing, William White did not hold a position in any of the aforementioned securities.
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Boston Scientific faces 48k lawsuits over pelvic mesh implants: 5 things to know
| Becker's Hospital Review
By Mackenzie Bean
Boston Scientific is involved in tens of thousands of lawsuits filed by women who experienced health complications related to the devicemaker's gynecological mesh implants, according to a "60 Minutes" report aired May 13.
Here are five things to know.
1. Of the more than 100,000 lawsuits women nationwide have filed against devicemakers over the mesh implants, about 48,000 suits involve Boston Scientific.
"It felt like a cheese grater inside of me," Gwyn Madsen, who received Boston Scientific's mesh implant in 2012, told "60 Minutes." "It felt like the material was pulling on the muscles, and I'd get shooting pains … you almost felt like there was something inside of you that was like sandpaper back and forth, every time you'd walk."
2. The company's mesh implants, used to treat stress incontinence, are made out of a type of plastic called polypropylene. In 2014, Boston Scientific's initial polypropylene supplier warned the devicemaker the plastic should not be used for "permanent implantation in the human body." A year later, the company cut off Boston Scientific's polypropylene supply.
3. To avoid seeking FDA approval for the device with a new material, Boston Scientific turned to a Chinese company with a large supply of polypropylene. The "60 Minutes" report cited an email exchange in which one Boston Scientific employee asked, "Do we need to ask [the Chinese company] if this material is supposed to be used in medical implantable?" In response, Boston Scientific's director of materials management said, "Please don't tell them where we will use it. It could scare them away," according to the report.
4. The FDA conducted an "extensive investigation" into the polypropylene after learning Boston Scientific changed suppliers, according to an official statement emailed to Becker's Hospital Review.
"The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications," the statement said. "As a result, the FDA concluded that the new resin does not raise new safety or effectiveness concerns."
5. Boston Scientific called the "60 Minutes" report "irresponsible and misleading," in an official statement on the company's website.
"The claims made by '60 Minutes,' which suggested that our transvaginal mesh products contain counterfeited and smuggled materials, are completely false," a company spokesperson told Becker's Hospital Review. "All of our products meet rigorous internal safety standards, as well as the standards of the FDA and other regulatory bodies."
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‘60 Minutes’ looks at lawsuits against Boston Scientific
| Boston Globe
By J.D. Capelouto
Boston Scientific, a Marlborough-based company and one of the largest manufacturers of a gynecological mesh implant, has been the subject of more than 48,000 lawsuits from over 100,000 women alleging that the plastic strip inflicts serious pain and injury, “60 Minutes” reported Sunday night.
Surgeons can implant Boston Scientific’s mesh product into women’s bodies in the hopes that it acts like a sling to relieve urinary incontinence and support organs after pregnancy. But many women, as well as doctors who are tasked with removing the implants, say the mesh can cause an inflammatory reaction, leading to shooting, uncomfortable pain, the newsmagazine reported. “It felt like a cheese grater inside of me,” Gwyn Madsen, who had a Boston Scientific implant in 2012, told “60 Minutes.” “... You almost felt like there was something inside of you that was like sandpaper back and forth, every time you’d walk.” The lawsuits over the gynecological mesh “make up the largest multi-district litigation since asbestos,” according to the “60 Minutes” report.RELATED LINKSRead StoryKitty Dukakis talks about treating depression with shock therapy
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Boston Scientific declined an interview to the newsmagazine, but said in a statement that nearly 1 million women have been “successfully treated” with the mesh and that the plastic is safe.
Experts interviewed by “60 Minutes,” however, said that the plastic Boston Scientific used in the mesh stems from a sketchy broker in China, and is unsafe for use in the human body.
One plastics engineer, Duane Priddy, told “60 Minutes” that he was surprised the material used in the implant — a brand of polypropylene that was approved by the FDA but caused the plastic suppliers to raise concerns in 2004 — was ever OK’d. “I can’t, in my wildest imagination, imagine anybody that’s knowledgeable in the science of plastics ever deciding that it was appropriate to use polypropylene in the human body,” said Priddy, who is not part of any lawsuits against the company. “It’s well known that it’s oxidatively unstable.”
When the plastic maker said in 2005 it would cut off Boston Scientific’s supply of the material, the Massachusetts company turned to another source in China to get the FDA-approved brand of polypropylene to continue making the lucrative implants, according to the “60 Minutes” report.
“The FDA requires Boston Scientific and companies like it to understand every step in the supply chain. In other words, who made the material, who packaged it, who shipped it, et cetera,” CBS reporter Scott Pelley explained on the program before asking, “How much did Boston Scientific understand about that supply chain?”
“They don’t seem to know where the material is coming from. Nobody knows who the original manufacturer is,” answered Chris DeArmitt, a plastics engineer who researched the company for one of the women suing the company. “Nobody knows and that’s a big deal, right? You have to take a record of every lot, was it contaminated? Has it been tested? And they don’t know any of those, any of those answers.”
In a statement to the Globe on Monday, FDA representatives said that officials there conducted an “extensive investigation” after Boston Scientific changed suppliers for the polypropylene used in the gynecologic mesh products. “The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications,” a statement from the agency said.
In a statement to the Globe early Monday, company officials said they “reject the allegations made by ‘60 Minutes’ which claimed our transvaginal mesh products contain counterfeited and smuggled materials. These claims are completely false.”
A separate statement posted to Boston Scientific’s website called the “60 Minutes” story “irresponsible and misleading,” adding that the broadcast “resurfaced outdated and previously disproven allegations first made by attorneys in 2016.”
“We provided the show with a statement and are disappointed that our perspective, and those of medical societies and the healthcare community, were not fully reflected in the broadcast,” the statement said. “Instead, the show offered a one-sided view and commentary from clinicians and plastic experts involved with litigious actions.” ***
The following is the full statement provided to the Globe by Boston Scientific representatives:
“We reject the allegations made by ‘60 Minutes’ which claimed our transvaginal mesh products contain counterfeited and smuggled materials. These claims are completely false.
All of our products meet rigorous internal safety standards as well the standards of the FDA and other regulatory bodies. Leading physician societies have issued supporting statements on mesh, and the American Urogynecologic Society recently shared its perspective.
At Boston Scientific, our top priority is ensuring that all our products are safe and effective. We remain steadfast in our commitment to women’s health.
The majority of patients have benefited from our innovations and we remain dedicated to offering safe and effective products to help treat these and other conditions. We have and will continue to do what is right for patients.
One in three women globally is affected by a pelvic floor disorder. We recognize it is in the best interest of all to ensure that products are properly tested, safe and effective for patients who need them. In September 2017, the FDA completed a thorough review and concluded that the change in our resin supplier did not raise any new safety or effectiveness concerns.
We continue to invest in studies to provide the medical community with additional clinical evidence to support ongoing treatment decisions. There are more than 60 clinical publications available in support of our pelvic floor products. We currently have three 522 post-market clinical studies ongoing in the U.S. There are an additional 14 investigator-sponsored research studies on our pelvic floor products underway.
These mesh products contribute to only one percent of sales to Boston Scientific annually, so this is not about profits. It is about doing what is right for patients who have few treatment options for these debilitating conditions.”
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The following is the full statement provided to the Globe by FDA officials:
“The FDA takes its commitment and obligations to patient safety very seriously. After the FDA became aware that Boston Scientific changed suppliers for the polypropylene resin used in the gynecologic mesh products, we conducted an extensive investigation. The FDA conducted its own testing of the finished product for specific mechanical properties and physical characteristics and determined that all samples met the appropriate specifications. We also evaluated information [data and analysis], from various sources available to the FDA including the company, regarding the polypropylene raw material, as well as the finished mesh manufactured with polypropylene resin from both sources, and we conducted inspections of Boston Scientific and two of its contract manufacturers. Further, we reviewed our adverse event reporting database and did not find any indication that the change in resin led to an increase in adverse events. As a result, the FDA concluded that the new resin does not raise new safety or effectiveness concerns. In December of last year, we asked 60 Minutes for the opportunity to review their test results and hoped they would have provided this information as soon as possible, especially if they believed this data could impact public health. They declined until after their report aired, and we still have not received this information. While we have confidence in our investigation findings, we welcome any new information that would help us better evaluate this product and protect the health of patients.”
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| Mass Live
By Michelle Williams
A medical device manufacturer based in Massachusetts is facing tens of thousands of lawsuits from women.
In a "60 Minutes" report aired Sunday, the news program looked into the issue of gynecological mesh, an implant used to treat stress incontinence - a common condition expierenced by women after childbirth.
Boston Scientific, a Massachusetts-based company, is one of the largest manufacturers of the device.
More than 100,000 women across America who reported complications with gynecological mesh have filed suit. Of those lawsuits, 48,000 were filed against Boston Scientific.
"It felt like a cheese grater inside of me," one woman who had an implant created by Boston Scientific told "60 Minutes." "It felt like the material was pulling on the muscles and I'd get shooting pains you almost felt like there was something inside of you that was like sandpaper back and forth, every time you'd walk." Boston Scientific switched suppliers of the polypropylene in the past decade after their previous supplier issued a warning that the plastic must not be used for "permanent implantation in the human body," "60 Minutes" reports. The company sought to continue using the plastic mesh, as it already had FDA approval, "60 Minutes" reports, and found a company in China that had a large quantity of it, enough to last several decades worth of sales.
In an email exchange made public regarding the planned purchase, one Boston Scientific employee wrote "do we need to ask [the Chinese company] if this material is supposed to be used in medical implantable?" To which Boston Scientific's director of materials management wrote back, "please don't tell them where we will use it. It could scare them away," the newsmagazine reports, of the exchange.
Of the change in suppliers, the FDA said in a statement shared with MassLive that "an extensive investigation" was conducted and federal officials found "that all samples met the appropriate specifications."
The report features interviews with several medical and plastics experts expressing concern about the mesh.
A surgeon who has removed hundreds of mesh implants told "60 Minutes" he has seen implants "substantially altered" by the time they're removed.
"They are shrunk by at least 50% in width; they are encased in scar tissue. The pores here, these openings here are shrunk substantially," Michael Margolis, a doctor who has testified in lawsuits against medical manufacturers said. Boston Scientific declined to speak on camera for the story, offering a statement. "Nearly one million women have been successfully treated... We have extensively tested the [plastic] resin to confirm its composition, safety and performance."
Additionally, the American Urogynecological Society has said plastic mesh is "safe and effective."
Founded in 1979, Boston Scientific is headquartered in Marlborough, Massachusetts. The company employs about 27,000.
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Boston Scientific besieged by lawsuits over gynecological mesh implants amid 60 Minutes report
| Proactive Investors
This marks the biggest litigation movement since lawsuits against asbestos manufacturers. As many as 48,000 lawsuits from more than 100,000 women have been lodged against Boston Scientific (NYSE:BSX), a US medical-device manufacturer, over its plastic gynecological mesh implants which are alleged to cause “life-altering” pain and injury, according to a 60 Minutes report Sunday night.
The number of lawsuits involved make the effort on the part of these women, the largest litigation movement since lawsuits were taken out against asbestos manufacturers in the 1990s.Mesh comprised of polypropylene used in packaging
Surgeons employ the gynecological mesh in a way similar to a sling to relieve urinary incontinence and to lift organs that shift after pregnancy.
But thousands of women report suffering shooting pains and feeling as if sandpaper is inside of them post the implant of the mesh, which is designed to be permanent.
“It felt like the material was pulling on the muscles and I’d get shooting pains you almost felt like there was something inside of you that was like sandpaper back and forth, every time you’d walk,” one woman told "60 Minutes."
Doctor Michael Margolis, a witness in the lawsuits against Boston Scientific, said the width of the implants he removed had shrunk by as much as 50% and they were covered in scar tissue.
The mesh is comprised of a plastic called polypropylene, which is used in packaging.
Boston Scientific originally got the go-ahead from the US Food and Drug Administration to use Marlex, a brand of polypropylene made by a unit of Chevron Phillips. But after being concerned about the idea that Marlex was being used for medical purposes, Chevron Phillips refused to supply Boston Scientificwith it. The plastic most recently used in the mesh stems from a broker in China and is not safe for human use.
Rick Wise, an analyst with the broker and investment banking house Stifel, called the 60 Minutes report "unsettling...but likely overstated," in a research note to investors first obtained by the Fly, the business news site.
Wise pointed out that Boston Scientific has either reached or is near a settlement on 47,500 of the known 49,500 mesh legal claims and has a US$1.5bn reserve in place for related litigation. The company expects most of the remaining mesh claims to be resolved this year.
Boston Scientific shares were flat at US$30.08 in early trade.
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60 Minutes report claims unapproved plastic sources used in Boston Scientific pelvic meshes
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