May 14, 2018

Boston Scientific responds to '60 Minutes' episode on transvaginal mesh allegations

Courtesy | Boston Scientific
Boston Scientific's headquarters are located in Marlborough.

Medical device maker Boston Scientific is responding after a "60 Minutes" segment that aired Sunday highlighted claims that the company's transvaginal mesh products are ineffective and harmful.

Claims have been made in 48,000 lawsuits against Boston Scientific that the products cause harm, according to "60 Minutes."

"It felt like a cheese grater inside of me," said Gwyn Madsen, a patient quoted in the episode.

Further, the segment cited concerns from doctors and other experts that the company misled U.S. regulators into thinking the product was made in Texas after they began being made overseas.

In a statement Sunday night, Boston Scientific called the claims false.

"The broadcast resurfaced outdated and previously disproven allegations first made by attorneys in 2016," read a statement written by Chairman and CEO Mike Mahoney and Executive Vice President, MedSurg, Dave Pierce. "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 segment cited sources who said that when a Texas company began refusing to sell plastic mesh to Boston Scientific, the company turned to a Chinese company that allegedly sold counterfeit material.

However, Mahoney and Pierce cited conclusions from the U.S. Food and Drug Administration that said the Chinese material did not lead to a rise in adverse health effects.

"We believe that this story was irresponsible and misleading," the Boston Scientific executives wrote. "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."

Boston Scientific also called the segment "one-sided" with commentary from clinicians and plastic experts involved in ongoing litigation.

Mahoney and Pierce defended the company's use of polypropylene-based plastic devices after a plastics expert was quoted on the show saying the material should never be used in the human body, and other allegations that the company's alleged deception was driven by profits.

"Our mesh products contribute to only one percent of annual sales to our company. Continuing to provide these mesh products is not about profits," the executives wrote. "It is about doing what is right for patients."

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