Johnson & Johnson is accused of releasing transvaginal mesh implants with the knowledge that the implants were defective.

The Prolift transvaginal mesh implants were designed to treat pelvic floor prolapse, a condition where the pelvic organs such as the bladder weaken and drop into the vaginal area. However, Johnson & Johnson allegedly released the transvaginal mesh implants without approval from the U.S. Food and Drug Administration.

The company reportedly claimed that, since the Prolift products were so similar to preexisting transvaginal mesh implants, they didn’t think they needed approval. The FDA allegedly didn’t know Johnson & Johnson had released their products without approval until they were alerted three years later.

Johnson & Johnson withdrew their Prolift transvaginal mesh products in 2012 after the FDA demanded further testing, but many women allegedly suffered from complications due to the mesh. Further evidence suggests that the attempting to get approval may have prevented the release of the Prolift transvaginal mesh implants.

Emails from Johnson & Johnson staff members revealed by The Guardian allegedly show that there were concerns that the Prolift transvaginal mesh implants would turn “hard as a rock” and shrivel up like a “folded potato chip”. The emails were submitted as part of a civil case filed against Johnson & Johnson alleging that the transvaginal mesh implants caused plaintiff Suzanne E. to experience complications.

Suzanne was implanted with the Prolift transvaginal mesh in 2007 and says she was shocked when the mesh cut through her vagina months later. She alleges her husband was able to feel the mesh while the couple had sex, a feeling he describes as like “barbed wire.”

Documents submitted as part of Suzanne’s lawsuit detail correspondence from surgeons who were concerned about the efficacy and safety of the transvaginal mesh implants. Months after the product launch in 2005, Professor Linda Cardozo from King’s College Hospital in London allegedly told a senior manager at Johnson & Johnson that she found the mesh’s safety “quite worrying” especially considering that she and other doctors had “no efficacy data to review”.

“I still have major concerns regarding the erosion rate and possible problems with [sex becoming painful],” Cardozo wrote.

Legal evidence also references a study of 90 women who were implanted with the mesh between 2004 and 2006. The doctors in the study allegedly reported a failure rate of 18 percent. Nine percent of women allegedly reported an erosion of the mesh into the vagina and 13 percent of women reported “moderate or severe vaginal retraction”.

Johnson & Johnson reportedly declined to comment to the Guardian when the news outlet reported on the documents in the civil case. However, the company said the following in a 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.”

Suzanne’s lawsuit is not the first time Johnson & Johnson transvaginal mesh implants have come under fire. Countless other consumers have filed lawsuits regarding the Prolift and other mesh products after experiencing severe complications which were allegedly due to defective product design.