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Officials Aware of Prolift’s High Complication Rates, Records Reveal

June 13 2013 Published on #vaginal mesh, #health, #news, #women

Several studies conducted on the Prolift vaginal mesh before its distribution in 2005 had shown results indicating very high complication rates, court record reveals, showing evidences presented during the trial of Linda Gross against Ethicon. Recommendations coming from the company’s own research group tended to agree with these results.

In one study involving 684 patients from different medical centers in France, it was found that complication rate was 33.6 percent after only six months of surgical procedure using the Gynecare vaginal mesh. Seventy-seven patients experienced mesh exposition and another 80 reported having mesh retractions. Recurrence of organ prolapse was also reported by 36 women and another 37 patients claimed to have developed stress urinary incontinence (SUI) after the procedure.

These developments greatly concerned researchers at that time. They were fully aware of the impact of these complications on the women who may be implanted with the vaginal mesh device. An example of this concern was demonstrated by the French medical doctor in charge of the development of the Gynecare Prolift when he sent a message to a senior Ethicon official expressing his view that the use of the Prolift may lead to erosion and retraction which may interfere with sexual intercourse once the vaginal cavity experiences anatomical distortion.

Other concerns raised by the members of the research team included the possibility of mesh shrinkage or contraction due to the materials used. According to these experts, once scar tissues are formed due to the material’s porosity, mesh shrinkage may occur which may lead to complications causing severe pelvic pain, infections, and extreme pain during sexual intercourse.

The recommendations of different experts were not heeded, probably due to financial or other considerations, and Ethicon decided to introduce in 2005 the Gynecare Prolift vaginal mesh. It has been alleged that in launching the Gynecare Prolift, information on the product’s safety and efficacy which should have been included in official documents and in the product’s labels and other literature were intentionally omitted.

When it was made available to the market in 2005, the Gynecare Prolift vaginal mesh enjoyed huge success. This success may be considered short-lived since after only a few years, complaints of severe complications attributed to the use of these products started to crop up.

Linda Gross, who stood as plaintiff in a recently concluded vaginal mesh lawsuit filed against Ethicon for the pain and suffering she sustained as a result of using the Prolift vaginal mesh, was among the first patients implanted with this supposedly innovative device. The jury, after a month of continuous trial, found Johnson & Johnson guilty of the charges brought up by Linda Gross and ordered to pay $11 million as compensatory and punitive damages.

References:
ncbi.nlm.nih.gov/pubmed/18937698
meshmedicaldevicenewsdesk.com

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