60 Minutes Takes on Gynecological Mesh

Gynecological mesh (also referred to as pelvic mesh) has become a massive threat to women’s health. Over 100,000 women are suing manufacturers of these devices, creating the largest multi-district litigation since asbestos. But despite the massive outcry of patients and anti-mesh advocates in the US and Europe, the crisis hasn’t received much mainstream attention. That changed this past weekend, when 60 Minutes shined a light on the problem in a segment on gynecological mesh.

The 60 Minutes piece focused on Boston Scientific, the medical device company that alone is facing 48,000 gynecological mesh lawsuits.

Prior to 2005, Boston Scientific used a type of polypropylene plastic called Marlex for its gynecological mesh. Following concerns of the medical application of Marlex, manufacturer Chevron Phillips issued a warning that Marlex must not be used for permanent implantation in the human body, stating “We are simply not interested in this business at any price.” Because Marlex had already been accepted by the FDA, Boston Scientific needed to find an alternate supplier.

Boston Scientific settled on Emai, a Chinese broker who claimed to have vast supplies of Marlex that had been imported from Chevron Phillips. Despite lacking documents proving the Marlex was manufactured by Chevron Phillips, incorrect lot numbers on the bags suggesting the mesh was counterfeit, and internal testing that revealed significant differences between the original and Chinese meshes, Boston Scientific purchased enough of the Chinese polypropylene to last 30 years.

The plastic was effectively smuggled out of China in plain wrappers, as internal emails from Boston Scientific revealed that a lack of import records could create issues with customs.

In order to understand the difference between the authentic and Chinese plastic, 60 Minutes hired an independent consultant named Duane Priddy to analyze the test results. Dr. Priddy is widely considered to be one of the preeminent specialists on the engineering of plastics and has appeared as an expert witness in previous mesh lawsuits. In fact, Wexler Wallace first learned of Dr. Priddy in related litigation against another mesh manufacturer.  Edward Wallace worked with Dr. Priddy to learn additional facts about the plastics involved and later took his deposition in the case of in re American Medical Systems, INC. Pelvic System Products Liability Litigation MDL: 2325. Edward Wallace later hired Dr. Priddy as an expert in the pelvic mesh litigation where Dr. Priddy conducted testing on pelvic mesh, which confirmed his opinion that the material being used was oxidative and unstable.  Wexler Wallace attorney Tim Jackson has also worked closely with Dr. Priddy, who is serving as an expert witness for the Plaintiffs in Litigation against Ethicon, another manufacturer of pelvic mesh.  We support the work of Dr. Priddy and others who continue to investigate these claims.

Excerpts from Wexler Wallace’s deposition of Dr. Duane Priddy

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.

Before concluding the segment, 60 Minutes revealed that it had purchased 15 of Boston Scientific’s mesh kits, to have them tested by a leading plastics lab. All 15 matched the Chinese plastic.

Suddenly, it makes a lot more sense why nearly half of the gynecological mesh lawsuits are directed at Boston Scientific.

To watch the 60 Minutes segment in its entirety, please visit CBSNews.com.