Before its introduction in 2005, there were already several studies conducted on the Prolift vaginal mesh which showed results indicating very high complications rates, court record reveals, showing evidences presented during the trial of Linda Gross against Ethicon. The company’s own research group also presented recommendations that appeared to agree with these findings.
It was revealed that complication rate was 33.6 percent after only six months of surgical procedure using the Gynecare vaginal mesh, according to one study involving 684 patients from different medical centers in France. A total of 80 cases of mesh retractions were reported while another 77 patients experienced mesh exposition. There was also a recurrence of organ prolapse in 36 patients and at least 37 respondents had developed stress urinary incontinence (SUI) after the procedure.
Researchers at that time were very concerned about these developments. They were fully aware of the impact of these complications on the women who may be implanted with the vaginal mesh device. That the use of the Prolift may lead to erosion and retraction which may result to anatomical distortion of the vaginal cavity that may interfere with sexual intercourse was one concern raised by a French doctor who was in charge of the team responsible for the development of the Gynecare Prolift.
The possibility of mesh shrinkage or contraction due to the materials used was another concern raised by members of the research team. 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.
In 2005, Ethicon decided to launch the Gynecare Prolift without heeding the recommendations of the different experts. In the process, information pertaining to the product’s safety and efficacy were allegedly omitted in the official reports and in the product’s labels and other literature.
The Gynecare Prolift vaginal mesh enjoyed huge success when it was made available to the market in 2005. Complaints of severe complications attributed to the use of these products starting to emerge after only a few years, cutting short its successful run.
In 2006, this supposedly innovative device was implanted on Linda Gross which she claimed caused her pain and suffering, which resulted to the filing of a vaginal mesh lawsuit against Ethicon. After a month of continuous trial, Johnson & Johnson, through its subsidiary, was found guilty of the charges brought up by Linda Gross and was ordered by the jury to pay damages amounting to $11 million.
References:
ncbi.nlm.nih.gov/pubmed/18937698
meshmedicaldevicenewsdesk.com
It was revealed that complication rate was 33.6 percent after only six months of surgical procedure using the Gynecare vaginal mesh, according to one study involving 684 patients from different medical centers in France. A total of 80 cases of mesh retractions were reported while another 77 patients experienced mesh exposition. There was also a recurrence of organ prolapse in 36 patients and at least 37 respondents had developed stress urinary incontinence (SUI) after the procedure.
Researchers at that time were very concerned about these developments. They were fully aware of the impact of these complications on the women who may be implanted with the vaginal mesh device. That the use of the Prolift may lead to erosion and retraction which may result to anatomical distortion of the vaginal cavity that may interfere with sexual intercourse was one concern raised by a French doctor who was in charge of the team responsible for the development of the Gynecare Prolift.
The possibility of mesh shrinkage or contraction due to the materials used was another concern raised by members of the research team. 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.
In 2005, Ethicon decided to launch the Gynecare Prolift without heeding the recommendations of the different experts. In the process, information pertaining to the product’s safety and efficacy were allegedly omitted in the official reports and in the product’s labels and other literature.
The Gynecare Prolift vaginal mesh enjoyed huge success when it was made available to the market in 2005. Complaints of severe complications attributed to the use of these products starting to emerge after only a few years, cutting short its successful run.
In 2006, this supposedly innovative device was implanted on Linda Gross which she claimed caused her pain and suffering, which resulted to the filing of a vaginal mesh lawsuit against Ethicon. After a month of continuous trial, Johnson & Johnson, through its subsidiary, was found guilty of the charges brought up by Linda Gross and was ordered by the jury to pay damages amounting to $11 million.
References:
ncbi.nlm.nih.gov/pubmed/18937698
meshmedicaldevicenewsdesk.com
RSS Feed