Transvaginal Surgical Mesh

It has been said that those who don’t learn from history are doomed to repeat it — a lesson that Jeffrey Shuren, director of the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, thinks the agency should take to heart.

On the heels of FDA approved hip implant and vaginal mesh products that have spurred a glut of patient injury complaints and hundreds of lawsuits, the device chief says that he agrees with some House democrats that the FDA should have more power to block unsafe products from coming to market.

At the heart of the debate is the agency’s 510(k) approval process, which is less stringent than its drug approval system, and allows devices to go to market without human testing as long as the FDA considers them “substantially equivalent” to previously approved versions, known as predicates.

And that is the crux of the problem, according to Shuren. He told Bloomberg News that by law, the FDA has to approve devices that “cite an eligible predicate.” The only exception is if the older product was subject to an FDA or court mandated recall. Since most manufacturers voluntarily recall products with safety issues, new products are still approved based on those older recalled products.

So some vaginal mesh implant products were approved by the agency despite the fact they traced their designs to a product that had been recalled by Boston Scientific Corp.

Four House Democrats proposed legislation last month that could give the FDA a firmer grip on this approval process. While Shuren hasn’t endorsed the bill, he does approve of a legislative fix that would assure “that if there is a problem with a new device, it gets addressed before it goes to market.”

The Tallahassee transvaginal mesh injury attorneys at Farah & Farah applaud these proposed FDA reforms and will be keeping track of these matters as they develop.

Source: http://www.businessweek.com/news/2012-02-29/fda-device-chief-says-approval-loophole-needs-to-be-closed.html

As the Florida transvaginal mesh lawyers of Farah & Farah are talking to women who are experiencing complications from synthetic vaginal mesh, we realize we are sometimes hearing those stories too late. Here is a case in point.

A federal judge has just dismissed a lawsuit filed by a Georgia woman after it was determined her lawsuit against a vaginal mesh manufacturer was filed outside of the two-year statute of limitations in that state. The woman filed her lawsuit in July 2011. She had the Boston Scientific Pinnacle Pelvic Floor System implanted along with a Prefyx Pre-Pubic Sling in 2008 after a hysterectomy for pelvic reconstruction surgery.

By March 2009, she experienced transvaginal mesh complications, including having the mesh erode into her vagina. She experienced stress urinary incontinence and chronic pain. Her case was to be heard individually, not part of the larger classes that are consolidating. She alleged Boston Scientific was negligent in making a defective mesh product.

Unfortunately, her lawsuit was dismissed by Judge Thomas W. Thrash in the federal court for the Northern District of Georgia. Her deadline to file was March 2011, two years after she first experienced a problem. The judge decided there were not extenuating circumstances that would justify extending the deadline for this woman. The decision in this case does not affect the other cases being consolidated in Multidistrict Litigation (somewhat similar to a class action), but this woman has exhausted her options.

We are sorry to hear this. In Florida, the time period for beginning a personal injury claim is longer; however, when you first experience complications is subject to debate. Synthetic surgical mesh complications include: erosion, infections, pain and discomfort, and in some cases, an inability to move or walk.

Farah & Farah has a no-fee policy in taking your case until you receive a settlement. Let’s start the conversation at 1(800) 533-3555 so this doesn’t happen to you.

Source:http://law.justia.com/cases/federal/district-courts/georgia/gandce/1:2011cv03023/177794/12; http://www.statutes-of-limitations.com/state/florida

You may be hearing a lot of news about transvaginal or synthetic surgical mesh used in women. The U.S. Food and Drug Administration (FDA) has not recalled the defective product, but it has come as close as it can to doing so. Synthetic mesh is made by nine companies, but most of the news and lawsuits revolve around four manufacturers, C. R. Bard, Ethicon (Johnson & Johnson), American Medical Systems (AMS), and Boston Scientific.

The FDA does not require these companies to do clinical trials before the mesh is marketed to doctors and the public, unlike the more stringent review required of drugmakers. Instead, mesh is grandfathered in under a process called 510(k), which is an FDA approval for marketing only – no assurances for safety are required. It’s basically an exchange of paper with the manufacturer claiming the medical device is substantially similar to one already on the market. The problem is one of the first meshes used as a “predicate,” the ProteGen, was taken off the market for being defective. You would think that would spark an internal FDA investigation to see if the defect was present in the meshes that followed. That never occurred.

Most recently, the FDA asked 35 manufacturers of mesh for pelvic organ prolapse and stress urinary incontinence to conduct three-year follow-up studies on women who receive the permanent implant. With all of the news about transvaginal mesh side effects and complications, it may be difficult to find a patient population to follow for three years. And with thousands of complications already reported, it seems that these women are walking into a potentially life-altering situation to have permanently implanted mesh when it is nearly impossible to remove if there are complications.

Even the FDA said in its July 13, 2011 Public Notification that complications are “not rare” and that the benefit of synthetic may not be outweighed by the risks it poses.

Complications include a return of incontinence and prolapse, debilitating pelvic pain, nerve and organ intrusion, mesh erosion, migration and shrinkage, repeated infections, and in some cases, death. The lawsuits representing thousands of injured women will begin being heard at some point in 2012, but meanwhile, the FDA has given manufacturers an additional three years to study the effects. Most of the public assumes that was done before the mesh was put on the market, not after. Meanwhile upward of 300,000 women will have mesh implanted as a treatment and many will not be aware of the controversy surrounding the defective product.

The Florida transvaginal mesh failure lawyers at Farah & Farah is talking to women who are suffering the complications of this defective product. Call us at (800) 533-3555 so we can offer you a complimentary consultation on your situation. The sooner you act, the sooner you might be able to find relief and compensation for your injury.

Source: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/default.htm

A number of U.S. Representatives are asking the Energy & Commerce Committee to conduct hearings on medical devices that are causing serious injuries to patients, including transvaginal synthetic mesh.

Mesh is frequently used to treat pelvic organ prolapse and stress urinary incontinence in women. The synthetic material, made from polypropylene, a petroleum-based product, is implanted vaginally in a blind procedure. Thousands of women have complained of intense pelvic pain as the mesh migrates in the body and erodes through organs. In many cases, women opt to have it taken out, but this implant is intended to be permanent and there are few qualified surgeons in the country who can remove it all.

The Democrats, Henry Waxman, Diana DeGette, and John Dingell, sent a similar request for a hearing on two other defective medical devices last October, but those hearings were never scheduled. In the letter, committee members are reminded that the U.S. Food and Drug Administration (FDA) has seen a five-fold increase in the number of complications associated with transvaginal mesh.

Synthetic mesh is considered a Class II medical device, but just last week the FDA announced it was considering making it a Class III device. At the same time, the FDA sent letters to 33 manufacturers to plan to conduct three years of post market studies to get an accurate picture of the complication rate. At the present time, there is no accurate accounting of the number of complications associated with implanted synthetic mesh.

The transvaginal mesh failure lawyers in Florida of Farah & Farah are talking to women who are experiencing complications following the placement of transvaginal mesh for pelvic organ prolapse and incontinence. These cases will move forward sometime in 2012 to bring some remedy to the thousands of injured women.

As with many product liability actions, there is a limited time period within which to talk to an attorney. Farah & Farah have an experienced and compassionate staff who understand how to listen. Call us at 1(800) 533-3555 to start the process.

Source: http://democrats.energycommerce.house.gov/index.php?q=news/democratic-committee-leaders-call-on-committee-republicans-to-hold-hearings-on-dangerous-medica

It seems sort of backwards. With an estimated 300,000 synthetic surgical mesh operations in 2010 for female pelvic organ prolapse and incontinence, you’d think the Food and Drug Administration (FDA) would understand the complications associated with the medical device.

But now Bloomberg reports the FDA has sent a letter to 31 medical device and mesh manufacturers requiring them to order three years of clinical trials on safety and effectiveness. This comes after the FDA announced last July that there had been a five-fold jump in injuries and deaths tied to synthetic mesh.

The manufacturers include Johnson & Johnson, C.R. Bard, Boston Scientific, American Medical Systems, Covidien, and Endo Pharmaceuticals Holding, among others. How did these devices get on the market without any testing? Under the current approval process, known as 510(k), a medical device can be approved for sale if it is equivalent to a similar device already for sale. There are no clinical trials required. Last September, an FDA panel recommended transvaginal mesh be reclassified to Class III, so that trials for safety and efficacy would be a required part of the approval process. It only makes sense for a device to be permanently implanted in the body. But manufacturers like the 510(k) process because it saves them time in research dollars and money.

Patient advocates have been raising the profile on mesh injuries related to pelvic organ prolapse and incontinence and for men suffering from a hernia mesh injury. The medical mesh device is a petroleum-based plastic that is known to erode, cause infection, shrink, and perforate nerves and organs. Thousands of women have reported adverse events or complications to the FDA’s database, which is thought to reflect a very small percentage of actual injuries and deaths.

If you or a loved one is suffering and has had synthetic surgical mesh implanted, it might be the cause of such complications. The symptoms are vast and varied and often a mesh removal is the only thing that will allow you to recover your health. Farah & Farah’s Jacksonville surgical mesh injury lawyers are talking to women who are suffering to seek compensation through a product liability action which will allow for the recovery of medical expense, lost wages, and pain and suffering.

Source: http://www.businessweek.com/news/2012-01-05/j-j-c-r-bard-must-evaluate-safety-of-vaginal-mesh-fda-says.html

In a rare joint release, two professional medical groups have come to the same conclusion. Due to all of the concerns about the dangers of synthetic mesh for the treatment of pelvic organ prolapse (POP), both the American College of Obstetricians and Gynecologists (ACOG) and the American Urogynecologic Society (AUGS) issued a joint recommendation on November 21 that the synthetic mesh should be used only on high-risk women due to the risks involved. The medical groups say the benefit may not outweigh the risk.

The two professional medical organizations also encourage the creation of a patient registry to track the outcomes after a woman is implanted with this permanent medical device that has a unknown complication rate. Currently, there is no national registry so the complication rate is unknown. It is widely believed that the U.S. Food and Drug Administration MAUDE database for complications is virtually unknown and does not reflect the actual number of injured patients who have been implanted with mesh.

Mesh is used when organs such as the uterus, small intestine, rectum, bladder, and top of the vagina drop down and bulge into the vagina, also known as POP. It’s believed that childbirth and certain genetic factors, as well as obesity and a lack of exercise, all contribute to the condition of weak muscles and connective tissue in the pelvic area. It’s also estimated that there are about 350,000 POP surgeries in the U.S. every year, however, not all involve mesh as simple stitches or a biologic material can be used. Synthetic mesh is used in an estimated 75,000 procedures a year.

Synthetic surgical mesh used for POP was cleared by the FDA in 2001 based on its “substantial equivalence” to hernia repair mesh. Unfortunately, under the 510(k) clearance process by the FDA, there is no clinical data required to prove the synthetic mesh is safe for patients or an effective treatment.

According to a FDA Notice issued July 13, 2011, complications of synthetic mesh for POP or stress urinary incontinence (SUI) include mesh erosion into the vagina and organs, infection, and debilitating pain.

The two professional medical associations recommend that synthetic mesh placement and success rates be compared to the use of native tissue harvested from the person and its long-term consequences.

The Florida transvaginal mesh injury attorneys at Farah & Farah are talking to women whose lives have been forever compromised by the use of synthetic surgical mesh. Call us at (800) 533-3555 to see how we can help seek compensation for your injury.

Source: http://www.acog.org/from_home/publications/press_releases/nr11-21-11-2.cfm

Following the U.S. Food and Drug Administration’s (FDA) July 13th warning about synthetic surgical mesh, the Florida transvaginal mesh lawyers at Farah & Farah have been hearing from women who say they feel the surgery for pelvic organ prolapse and incontinence caused more complications than it cured.

How do you know you are experiencing mesh complications?

It may be difficult to determine the source of your pain and discomfort because the symptoms can vary and can be somewhat obscure, and also they may not surface immediately after surgery. Some symptoms take years to show up and present in a general feeling of something being wrong. Other symptoms are immediate and obvious.

Some common symptoms of transvaginal mesh failure may include:

• Pain with Intercourse – If mesh is placed too close to the vagina or protrudes into the vagina, a partner can feel the mesh which can cause lacerations.
• Mesh Contraction – Synthetic prolene mesh is known to harden and can even move after it’s been implanted. The mesh can erode into the vagina or poke into organs, which can lead to pain and infection as well as a feeling of extreme pulling.
• Nerve Damage – Mesh is anchored in the pelvis and can attach to nerve endings or injure nerves when it is implanted. This is a pain that does not go away, even if the mesh can be removed.

Farah & Farah has heard from women who can no longer move normally and must spend the day lying down, and some are on narcotics just to get through the day. In some cases, the pain from a nerve injury is permanent. The question is whether it is the mesh placement, the mesh design, or its bio incapability with the human body, but mesh complications are real and women and even men are just now beginning to speak out; others who spoke out before the FDA notification were not taken seriously.

Farah & Farah takes these cases very seriously and we are prepared to offer you a complimentary consultation with a medical professional and our personal injury attorneys to try and obtain the compensation you deserve.

Call us at 1 (800) 533-3555, and remember there is a time limit within which to bring any case against the mesh manufacturer for a defective medical device.

The assumption is always the same – the U.S. Food and Drug Administration (FDA) checks drugs and medical devices for safety before it allows anything to be marketed, right? Not exactly. Thanks to a loophole within the agency, medical devices that are considered of moderate risk (Class II) do not have to have any premarket review, clinical trials, safety tests, and efficacy. They are generally assumed to be safe if they name a “predicate” device, one that’s already on the market.

In the case of modern synthetic or plastic surgical mesh used to treat incontinence and pelvic organ prolapsed (POP) in women, the Boston Scientific mesh called ProteGen is named as a predicate. However, ProteGen was pulled from the market a dozen years ago because of safety concerns and the FDA does not require a re-review of the mesh that followed.

Bloomberg reports that this is just the latest revelation that questions whether polypropylene mesh should ever have been approved to be marketed under the FDA’s 510(k) process.

Hundreds of lawsuits have been filed against nine mesh manufacturers, Boston Scientific, American Medical Systems and Johnson & Johnson among them. The product liability actions claim the mesh is defective and has lead to thousands of transvaginal mesh side effects including intense pain, disability, bleed outs, nerve damage, mesh erosion, and the perforation of organs. Seven deaths have been recorded.

In July, the FDA issued a warning to medical doctors and women that the benefits of mesh likely do not outweigh the risks and that consumers should seek solutions other than mesh for prolapse and incontinence problems. The FDA based its assessment on its own data, collected on its adverse event database MAUDE. But filing a report is difficult at best and many women don’t know their model number. Even with the difficulty of filing a report, there are thousands that the FDA knows about and likely thousands that the agency doesn’t.

The Florida transvaginal mesh injury attorneys at Farah & Farah are taking calls from women who have been implanted with surgical mesh and now believe they too may be experiencing a problem. A call to our product liability team will get us started looking into your case. Remember, the clock is ticking and there is a limited time within which to file an action, otherwise your opportunity will be gone. Call us at (800) 533-3555.

Source: http://www.bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device.html