The first ever Transvaginal mesh called ProtoGen, which was manufactured in 1996 by Boston Scientific, was recalled in 1999 owing to safety concerns and reports of adverse events. After a year of ProtoGen being released into the market, other companies started manufacturing mesh products and passed the clearance requirements by relying on section 510(k) that is part of the Food, Drug and Cosmetic Act. The 510(k) system simply allows a product into the market if it is similar to an already approved product.
However, during more recent times, there has been an increased concern regarding the complications associated with the placement of the surgical mesh. Taking into account the above-mentioned complications, Public Citizen, a consumer advocacy group has sent a petition to FDA to recall all Transvaginal Mesh products from the market.
Why the Transvaginal Mesh Recall Happened
Whereas, around only 1000 adverse cases associated with Transvaginal mesh devices were reported to the Food and Drug Administration (FDA) during 2005 to 2008, the number of adverse cases reports went up by 2,874 during the next three years (2008 to 2010). Of the total cases, 1,503 reports were of Pelvic Organ Prolapse (POP) patients and 1,371 cases were related to Stress Urinary Incontinence (SUI) repairs.
The most widely reported problems to the FDA included mesh erosion through the vagina (also termed as exposure, extrusion or protrusion). It can be very painful for some women and may require multiple surgeries. In some extreme cases, even multiple surgeries may fail. Other complications that were reported included pain, infection, bleeding, painful intercourse, organ perforation, and urinary problems. There were also reports about side effects such as recurrent prolapse, neuro-muscular problems, vaginal scarring or shrinkage, and emotional problems. These complications may require medical or surgical treatment and hospitalization.
Dr. Michael Carome, the deputy director of Public Citizen’s Health Research Group asserted that, “Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life.” According to the Group, future versions of the product should be classified as ‘class III’ or higher risk medical device and should undergo more rigid approval standards like human testing to ensure that the product is safe before it is marketed for clinical use.
To make a stronger case for mesh recall, officials at Public Citizen claimed that even the FDA is doubtful about the usefulness of the surgical mesh. A review of scientific literature published during 1996 to 2011 by FDA indicated that Transvaginal POP repair with mesh does not enhance symptomatic results, meaning that it doesn’t address the symptoms of POP, or the quality of life as compared to the traditional non-mesh repair.
Therefore, if you’ve developed a complication due to the placement of the mesh, you need to be well informed about your legal rights and options.Are you eligible to file a lawsuit?
If you or somebody who you know develops a complication due to the placement of a surgical mesh, you should consult a law firm that handles mesh related lawsuits. The lawyers will inform you about your legal rights and options and depending on your case, and help you in filing a lawsuit. You may be eligible to claim financial compensation for the expenses incurred/to be incurred in treatment as well as against the pain and suffering borne.To request more information related to your situation, please fill out the form on this page.
Q:Has there been any recent vaginal mesh recall?
A:In recent years, there have been a number of vaginal mesh recalls. Thousands of women who underwent this procedure have suffered from medical complications and issues. The mesh has been designed to treat pelvic organ prolapse and stress urinary continence. However, the product has led to a number of side effects and life-altering complications among women. The FDA has reported over 2,000 cases of vaginal mesh complications.
Q:What are these mesh recalls?
A:In recent years, the FDA has reported of numerous cases linked to vaginal mesh complications. This product has been designed to treat medical conditions such as stress urinary continence and pelvic organ prolapse. However, the product has also caused women to experience side effects such as vaginal mesh hardening, infections, and vaginal mesh erosions. Many of these products have been recalled by the FDA.
Q:Has the FDA taken any steps for mesh implant recall?
A:The FDA has taken into account the growing number of health complications caused by mesh surgeries all over. It has ordered many manufacturers to withdraw their products. With many lawsuits pending, lawyers and attorneys are working hard to make sure such devices are banned or recalled. Take a look at our page for more information.
Q:Why did mesh surgical recall take place?
A:Mesh surgical recall happened as many patients suffered from a number of side effects. There were some serious health effects on them as they suffered from mesh erosion, which is quite painful and may lead to multiple surgeries. Even multiple surgeries failed in some cases. There were several other complications like pain, infection, organ perforation, and urinary problems.
Q:Can you tell me when was the first bladder sling recall happened?
A:The first Trans vaginal mesh recall took place in 1999, due to the safety concerns and adverse effects of ProtoGen. ProtoGen was first manufactured by Boston Scientific in 1996. After the release of ProtoGen in the market, other companies started manufacturing similar products by relying on section 510(k) that is part of the Food, Drug and Cosmetic Act. This act allows a product in the market, which is similar to an already approved product.