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# Petition ‘Evidence’ Against Boston Scientific Mesh
- URL: https://www.fdaweb.com/petition-evidence-against-boston-scientific-mesh/
- Published: 2016-10-20T12:00:00.000Z
- Updated: 2026-09-14T21:41:14.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5137133

A [supplement](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1115-0052&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) to a 3/31 citizen [petition](https://www.fdaweb.com/petition-seeks-fda-recall-order-on-boston-scientific-surgical-mesh/) says it provides “evidence that the resin Boston Scientific Corp. (BSC) is currently using to manufacture its transvaginal mesh product **(1)** is not Marlex HGX-030-01, **(2)** is not supported by evidence proving its safety, and **(3)** cannot be characterized as homogenous.” The petition cites testing by Polymer Solutions establishing that resin used in the product is sourced from China and is not Marlex HGX-030-01 manufactured by Phillips. “The testing shows that the China-sourced resin has a unique additive package ‘fingerprint’ and over a dozen chemicals, most unidentified, that do not match the legacy sourced resin,” the document says.

The petition supplement claims that neither Polymer Solutions nor Boston Scientific have offered any evidence that the China-sourced resin, with its unique additive package, parabens, unidentified chemicals, and significantly different metal content, is safe to use in transvaginal mesh products. Rather, it says, Boston Scientific, at a minimum, has evidence that the China-sourced resin contains chemicals not safe for use in the human body, “which is particularly concerning considering this medical device cannot be removed.”

According to the supplement, “BSC does not know who made the China-sourced resin, who bagged the China-sourced resin, who assigned the lot number \[that\] is on the China-sourced resin, the meaning of the lot number, or who printed the lot number on the side of the bags of China-sourced resin.”

The petition reiterates a call that FDA recall all BSC transvaginal mesh products made with the China-sourced resin as there are other options available to women “that are not chemically contaminated or obtained from an unidentified source in China.”

The Mostyn law firm, which submitted the petition and supplement on behalf of a **Teresa Stevens**, also has a class action [suit](http://fdaweb.com/login.php?sa=v&aid=D5134458&searchWords=marlex&cate=S&stid=%241%24qG0.rK2.%24bBAGH%2FLYXiC.JH62WKw%2Fe0&ref=fdaweb.com) pending in West Virginia federal court charging that BSC participated in an international conspiracy to sell defective vaginal surgical mesh made from counterfeit materials smuggled from China.