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.
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.
Boston Scientific eventually purchased plastic purported to be produced by Chevron Phillips via a Chinese broker. Chevron Phillips told Boston Scientific three times that the lot numbers on the bags from China were wrong. pic.twitter.com/UxCKBh1SqX— 60 Minutes (@60Minutes) May 13, 2018
“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.”
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.”J.D. Capelouto can be reached at [email protected]. Follow him on Twitter @jdcapelouto.