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In 2017, New Zealand introduced restrictions on vaginal mesh last year citing safety concerns; in 2011 the FDA announced it would investigate claims into the danger of vaginal mesh after multiple women complained of untenable, childbirth-like, persistent pain. Now, in emails acquired by the Guardian, it has become apparent that Johnson & Johnson launched its own vaginal mesh, the Prolift implant, in 2005, despite knowing the mesh could harden inside the vagina, causing the patient pain—and did so without FDA approval.

From the Guardian:

Internal emails between executives, shared with the Guardian, show staff at Johnson & Johnson (J&J)were concerned that the plastic material the mesh was made from had the potential to turn “hard as a rock” and roll up like a “folded potato chip” inside patients....In one exchange, staff discussed how “shrinkage of the mesh may lead to pain.”

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All of this is coming to the forefront now because of a civil case filed by 60-year-old Pennsylvania resident Suzanne Emmett. She’s suing the pharmeceutical company on the grounds that the the Profit implant she received in 2007 perforated her vagina, resulting in 10 mesh erosions that required nine revision surgeries, several Botox injections, and multiple silver nitrate applications, Mesh Medical Device News Desk reports.

Johnson & Johnson declined to comment on the Guardian story, but shared the following statement:

“We think it is inappropriate to litigate these issues in the media or for conclusions to be drawn based on references to selectively chosen documents taken out of context.”