FDA Bares Warning Over Gynecare Prolift Vaginal Mesh

The U.S. Food and Drug Administration (FDA) in January 2012 asked Johnson & Johnson (J&J), and 32 other manufacturers to look into the rates of organ damage and complications linked to vaginal mesh implants. In 2010, doctors implanted more than 70,000 such devices in U.S. women to shore up pelvic muscles.

Johnson &Johnson’s Gynecare Prolift vaginal mesh implants have been a negative product for the company. Gynecare vaginal mesh lawsuit started to pile up after it ran into negative publicity.

The company introduced the Gynecare Prolift vaginal mesh device in March 2005, touting it in an annual report as an “innovative and effective surgical option” for weakened pelvic muscles. The FDA learned of the Gynecare Prolift after J & J cited it in July 2007 as a predicate for a follow-on device, the Prolift+M. 

However, in August 2007, the FDA warned Johnson & Johnson to stop marketing the Gynecare Prolift after the agency became aware that the product was being sold without FDA clearance. The FDA further required J&J to submit a so-called 510(k) application to review the Gynecare Prolift vaginal mesh. Even with the warning, J&J continued to market Gynecare Prolift for nine months while engaged in talks with the FDA.

Reports say that J&J faced no sanctions for failing to gain FDA approval and continuing to sell Gynecare Prolift after the agency ordered a stop.

J&J’s unauthorized marketing of the device might cost the company more to resolve Gynecare prolift vaginal mesh lawsuit over the product. Several reports have it that J&J already has endured recalls of artificial hip implants and over-the-counter drugs.

According to the FDA, manufacturing companies that sell devices without mandatory approval are subject to compliance actions like warning letters, seizure of illegally marketed devices, and injunctions or financial penalties against the companies and their managers.

The FDA has documented a number of instances of “organ perforation” or punctured vaginas upon using the product. When this occurs, most women must have an additional surgery to repair, replace, or remove their defective vaginal mesh. Unfortunately, medical experts cannot completely treat all types of vaginal mesh complications. For instance, severe vaginal scarring or nerve damage may permanently restrain a woman’s capability to engage into sexual intercourse without pain. With this, her quality of life may be severely damaged.

References:

• bloomberg.com/news/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval.html
• businessweek.com/news/2013-02-25/j-and-j-failed-to-warn-of-vaginal-mesh-risks-n-dot-j-dot-jury-rules
• online.wsj.com/article/SB10001424052702303506404577448422586204212.html

Transvaginal Mesh Surgery: What You Need to Know

Most of those who are afflicted with stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are women. According to health experts, around 200,000 American patients needed surgical operation for prolapse yearly, while around 34 million suffered from stress urinary incontinence based on the report by the National Association For Continence (NAFC). Medical interventions for these ailments vary from the invasive and non-invasive type. Transvaginal placement of mesh has become increasingly popular recently.

Transvaginal mesh existed for 20 years now, intended to entirely manage pelvic organ prolapse ailments which usually plague women after giving birth, menopause, or hysterectomy.You may develop pelvic organ prolapse when the tissues supporting your pelvic organs come to be fragile and struggling.It is said that around thirty to fifty percent of women may suffer from POP conditions throughout their existence and only two percent may be symptomatic.A sign of stress urinary incontinence is when there is seepage of urine upon doing involuntary things such as coughing or sneezing, or laughing and exercising as it puts pressure in the abdomen.

One way to treat these diseases is transvaginal mesh surgery. It is designed like a hammock made out of synthetic material which is surgically implanted through the vagina, in order to support the prolapsed organs. With the sling system, it helps the urethra to be firm in its place.With the sling in place, normal urinary function may be restored. The tightness of the mesh is regulated to lessen outflow of urine. As it was projected to help organs to stay in place, the device however, produced unwanted effects to its patients. 

Within the last three years, the Food and Drug administration (FDA) has over 1,000 side-effect reports about mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence. What you may see on the reports are side effects such as mesh erosion, pain, infection, and incontinence.In some rare cases, there are reports about destruction to one’s bladder, bowel, or blood vessel.Most of the patients described in the adverse event reports needed medical or surgical intervention, and some required hospitalization. 

Furthermore, a vaginal mesh implant known as Ethicon is a good example for this as several lawsuits have been filed against it due to its side effects. A recipient said that the pain was unbearable that it took her 18 surgical operations to pull out the vaginal surgical mesh.The panel sided with her claim that Johnson & Johnson was not able to caution its users of the threats linked with their device. 

If you are experiencing some of its adverse effects, have yourself checked instantly by a medical provider.

Sources:

webmd.com/urinary-incontinence-oab/tc/pelvic-organ-prolapse-topic-overview
usnews.com/health-news/family-health/womens-health/articles/2011/05/11/vaginal-mesh-surgery-effective-for-bladder-prolapse-repair-report