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  1. Florida

Sheldon joins victims of pelvic mesh implants calling for stricter FDA rules

Pamela Wise, a 41-year-old mother from Starke, and Elizabeth Way, 53, of De Leon Springs, took the podium at a press conference Wednesday and shakily described the suffering they've endured from having pelvic mesh implants, a topic that's been highlighted mostly in sensational TV ads paid for by trial lawyers. But the problem is real, they said.

"People have died and wanted to die because of this pain" Way, a former firefighter who now walks with a cane, said.

But the press conference also had a political message -- standing by Wise and Way was Democratic candidate for Attorney General, George Sheldon, adding his support while taking a dig at his opponent, Pam Bondi.

The attorney general "should be on the forefront" of an issue that affects so many women, Sheldon said. "This is what an attorney general should do. It's what Bob Butterworth did and what a number of attorney generals have done."

Sheldon's comments echo a common theme of Democrats, who charge Republicans don't support issues vital to women voters.

In an email, Bondi's communications director Jenn Meale responded that: "Since early 2013, Attorney General Pam Bondi's Office has been and remains on four executive committees actively engaged in multi-state investigations into four major surgical mesh companies, CR Bard, Inc., Endo Health Solution, Inc. (d/b/a American Medical Systems), Boston Scientific, and Johnson & Johnson's company Ethicon."

Jane Akre, editor of the Mesh Medical Device News Desk, said at the press conference that the group Corporate Action Network had sent letters to two dozen attorney generals across the country to gain support in fighting companies manufacturing these products and also push the Food and Drug Administration to reclassify these implants as "high risk." Akre said the group received responses from officials in California, Washington state, Texas, Pennsylvania and New York, but not from Florida's Attorney General Pam Bondi.

"As a woman, we thought she would respond," Akre said at the conference. Meale wrote in an email that the attorney general's office received a correspondence from Corporate Action Network, which callied for an investigation into Johnson & Johnson, "called twice and left messages, and never received a response from them."

At the press conference, Sheldon said Florida should wage the type of legal battle that worked against the tobacco industry.

He distributed copies of a letter he wrote to the Food and Drug Administration to finalize a proposed order to reclassify pelvic mesh implants, commonly used in patients who have pelvic organ prolapse or stress urinary incontinence, from Class II to Class III, which are generally the highest risk devices subject to more regulatory control.

Sheldon said more than 100,000 lawsuits are pending nationwide against seven manufacturers of pelvic mesh implants.

Both Wise, who worked in logistics for Walmart, and Way, said getting a pelvic mesh led to a personal and financial crisis for them and their families.

"I can't walk around. I don't leave my house," said a tearful Wise. "My kids lost their mom."

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