FDA Calls on Manufacturers of Surgical Mesh Devices To Do More Research

TVM Information

The US Food and Drug Administration (FDA) orders manufacturers of surgical mesh devices to conduct an in depth study of its safety and possible complications. The FDA sent letters to 35 manufacturers of surgical mesh devices to conduct three-year studies on hundreds of women who had surgical mesh implant to look into the adverse effects as well as the overall quality of life. The growing number of complaints to the agency called adverse event reports demonstrates that the use of the product to treat pelvic problems and to treat those with severe overactive bladder may be risky.

The FDA received more than 1,500 reports of complications related to the repairs using surgical mesh from 2008 to 2010, including instances of mesh erosion, vaginal bleeding and infection. The rate of reported adverse events was five times more than 2005 to 2007. The FDA was also concerned about scientific studies that show a lack of benefit from surgical mesh treatment, compared to non-mesh treatment. In line with this the agency is requesting for more studies from companies that manufactures the mesh for pelvic organ prolapse, (POP) surgery. In the case of transvaginal mesh used to treat stress urinary incontinence, (SUI), the FDA is seeking further study of the use of a so-called “mini-sling,”.

Previously, companies that wanted to make the mesh for POP or SUI could submit their application under a 510(k) accelerated review application that did not require them to do clinical trials in people, as long as they could show the products were similar to devices already out in the market. However, the FDA is now reclassifying the mesh as a high risk device. The manufacturers are now required to prove the product’s safety and effectiveness before it could launch. Companies applying for approval for class III devices may be required by the FDA to perform randomized controlled trials, scientific studies and post approval studies to demonstrate safety and efficacy in order to qualify for market approval. This is a more stringent process of approval required by the FDA to all surgical mesh devices.

At present the FDA continues to re-evaluate surgical mesh products. The agency encourages further studies to be conducted. It seeks to establish the causal connection of the reported adverse events to the use of the device. The studies might resolve the issues on surgical mesh complications and spare thousands of women from the hassle of having to file transvaginal mesh lawsuit.




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Medical Treatment Choices for Rectocele

Pelvic Organ ProlapseRectocele is a medical condition most women are uncomfortable to talk about. Prominent among the major types of pelvic organ prolapse (POP), it may be caused by a number of factors. Since naturally occurring conditions like childbirth may cause POP, women are generally prone to it and therefore should take precautions to avoid it.

In most cases, the treatment of rectocele is aimed at alleviating all the symptoms that are bothersome to the patient. It is important that this illness is identified at an early stage because severe cases of rectoceles are hardly treatable even with surgery.

There are steps that may halt the development of rectoceles. Firstly, constipation should be avoided. To do this, the patient should drink more than eight glasses of water every day, apart from other types of fluids she normally takes. A diet rich in fiber may also help with the easy passing of stools from the intestines. Stool softeners may be taken, but active forms of laxatives should be avoided since these can irritate the rectum and may lead to other problems.

Secondly, normal bowel motility should be maintained, so aerobic exercises are also encouraged. But activities that cause more abdominal pressure are not recommended. In cases of constipation episodes, it is not advisable to strain while defecating. To handle a difficult bowel movement, pressing the lower back wall of the vagina may ease this problem.

For women undergoing menopause, doctors may recommend estrogen therapy. This helps strengthen the pelvic floor muscles and prevent the occurrence of the other types of POP. Even when this kind of treatment has been proven to work with older women, careful observations should be made since it may also lead to the development of heart diseases, vaginal bleeding, and some forms of cancers.

In younger women, the use of a plastic or silicone device called pesary may be most practical. It may not completely correct rectocele, but it provides a temporary relief from its symptoms. The best thing about this device is that it is not too costly, compared to other treatment options. However, because it is not permanent, it needs to be monitored and cleaned from time to time. For busy women, this can be a hassle.

Lastly, surgery may be done for severe cases of rectocele or when the patient does not respond to all the alternative interventions. Although this does not guarantee safety and effectiveness, most patients have benefited from it. But like most treatment modalities, it is not without risk. One such surgery that is often performed to patients with rectocele is the use of a vaginal mesh implant. Some patients who received this treatment were not happy about the results of their operations after complications started to effect a change in their lifestyles.

Women are particularly sensitive when it comes to their health and the relationships they have with the ones close to them. When affected by a weakening condition like rectocele, they make sure they get the best treatment. Unluckily for some women who were not aware of some safety issues with mesh surgery, their only hope of recovering what they lost is through the success of the vaginal mesh lawsuit they filed. Until today, there are still many women who do not fully understand the potentially dangerous effects of surgical mesh.



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Vaginal mesh safety deserves priority, FDA says

The increasing concerns over the dangerous side effects of vaginal mesh have constantly stirred the public in recent days, media reports say. Because of this, the U.S. Food and Drug Administration (FDA) has been actively conducting studies for better understanding on the complications. The clear objective: To find out if there is a need to recall all of these medical devices. There have only been a few mesh recalls in the past and the recent case involved the Boston Scientific Pinnacle mesh recall.

The FDA has issued out regular danger warnings on these devices. Despite these announcements however, mesh manufacturers are still producing them in large volume at a faster rate. The makers of vaginal mesh even insisted that their use in health care facilities have been safe and effective, and serious injuries reported to them are rare. But, contrary to their assertions, incidences of vaginal mesh injuries and organ damage continue to grow across the United States.

Based on the information received by the FDA, almost 70,000 procedures of vaginal mesh implantation are performed annually for the treatment of women who have weakened pelvic floors, especially in cases of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The vaginal mesh acts as framework of support to the pelvic organs as it is threaded underneath the vaginal skin.

The FDA further sought the active participation of all mesh makers in conducting safety studies of these implants. Large companies like Johnson and Johnson and Endo-Pharmaceutical Holdings Inc. have agreed on safety standards. However, they refused to the reclassification of their products from moderate to high-risk category.

Product reclassification may include longer inspections and review times before new versions can be approved for distribution and sale in the market. This can be devastating to mesh companies, and would surely cost them a lot of money. If reclassification is approved, the FDA would be able to control clinical trials conducted by these mesh manufacturers. However, this is still to be decided by the agency after careful investigations are completed.

While it remains unclear whether vaginal mesh surgeries are more effective than non-mesh repair, the FDA indicated that vaginal mesh implantation be reserved for patients whose benefits of undergoing this procedure outweighs all possible risks. For other patients, traditional repair for POP and SUI are recommended.

Although the FDA is still weighing the possibility of vaginal mesh recalls and has been unable to come to a decision yet, it is continually conducting tests with the help of some mesh companies, doctors, and involved patients to better understand the risks that these medical devices may pose. Moreover, public health notifications are released from time to time as the agency’s research on this problem progresses and the numbers of filed vaginal mesh lawsuit continue to climb.


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Non-Absorbable Vaginal Mesh: Petitioned to be Removed from the Market

A clinical procedure called trans-vaginal mesh (TVM) implantation has already established a reputation until disturbing reports of its fatal consequences came out in big figures and stirred the public lately. Filed lawsuits against this procedure are piling up as the population of discontented recipients keep growing.

Trans-vaginal mesh procedures are intended to be carried out to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Trans-vaginal mesh (TVM) implantation is frequently performed for the surgical management of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). POP and SUI affect a great percentage of the adult women population all over the world. This results to more women undergoing TVM surgery.

The U.S. Food and Drug Administration (FDA) alerted the public about the potential risks caused by this procedure in 2008, and has been actively conducting investigations regarding the possible reclassification of vaginal mesh and is now studying the need of regulatory changes like clinical testing addressing the benefits and risks of using vaginal mesh for POP and SUI.

How is a recall initiated?

In a recall, the FDA suppresses the availability of a medical device or drug in the market after negative comments relating to the safety and effectiveness of that particular product are received from consumers. The recall of a medical device or a drug from the market must be justified by the tendency of it causing serious injuries or even death.

How is a recall classified by the FDA? How does FDA classify recalls?

Recalls are grouped into three classifications. Recalls which are most likely to cause debilitating injuries or death are classified as category I. Category II are those recalls that don’t frequently cause serious health threat but may pose a temporary negative effects. In category III recalls, products are not frequently related to serious health complications. After a recall is accomplished, the FDA ascertains that the recalled products are destroyed and appropriately reconditioned.

Why should vaginal mesh products be recalled?

In October 25, 2011, a consumer advocacy group called Public Citizen submitted an appeal to the FDA that all non-absorbable vaginal mesh be recalled. Representing over 225,000 concerned individuals, Public Citizen requests that selling of non-absorbable surgical mesh be discontinued because its advantage over non-mesh procedures as treatment for POP and SUI are not defined, and most patients who received it had developed high-risk and life-changing complications. The group also suggests that the FDA should approve all the non-absorbable vaginal mesh proposed to be marketed in the future only after adequate clinical trials that ensure their safety and effectiveness.

It is not clear when the FDA will make a decision about this request, but it is currently doing investigations on the surgical meshes involved with all the reported complications. The FDA is also considering the expanding of monitoring the device performance. The FDA is encouraging the recipients of TVM and all medical professionals to immediately report adverse reactions to the FDA to better understand the causes of these complications.



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