California Injury Attorney Blog

Last week, we posted on the recent FDA Obstetrics & Gynecology Devices Panel Advisory Committee hearings that centered on the use of transvaginal surgical mesh to correct Pelvic Organ Prolapse (POP). The second day of the advisory committee hearings focused on the use of surgical mesh for the surgical management of female Stress Urinary Incontinence (SUI), with differing recommendations from those regarding POP.

At the open public hearings, presenters ranged from patients to advocacy groups to clinicians. The presentations themselves also ranged widely from adverse event reporting to a broader review of clinical data.

Surgical mesh manufacturers also presented at the second day of hearings. The industry association AdvaMed advocated on the safety and effectiveness of what are known as suburethral slings to correct SUI. They do not believe that mandatory clinical studies are needed for the products currently being marketed. There are studies underway for products that have new features and they argued that this is sufficient. They also took the position that Class II special controls are adequate.

The FDA's review team also provided findings that were gleaned from their database that included data on both the safety and effectiveness on mesh suburethral slings used for SUI. Adverse events were described as well as a general summary of the device's risk-benefit profile. It was their conclusion that a reclassification is not necessary for the SUI mesh product. However, the FDA sought comment by the panel on the long-term safety and the effectiveness of a particular device called single-incision mini-slings.

The panel consensus with regard to the use of mesh for the correction of SUI (using retropubic and transobturator suburethral slings) was that the safety and effectiveness of these devices is well-established in that context. They did not believe that premarket clinical studies are necessary at this time. This view might change if there were significant changes in the material used or in the surgical procedure itself.

The panel did reach consensus that collection of adverse event information with regard to SUI correction should be coordinated and suggested that industry and health databases be used for this purpose. It was the opinion of the panel that post market studies for the SUI procedures using slings, are not necessary.

However, the panel did believe that premarket clinical studies are warranted with regard to the use of the single incision mini-sling in correcting SUI and that post market studies should also be performed with the mini-slings currently being marketed and that these should be compared in safety and effectiveness with conventional corrections.

Hersh & Hersh is a San Francisco, California consumer rights law firm that has been at the forefront of litigation involving women's health for four decades. We have litigated many landmark and historic cases, some of which involve medical procedures, defective devices and dangerous drugs that have adversely impacted women. If you have been injured by a procedure involving surgical mesh for POP or stress incontinence, please contact our law firm. We will consult with you free of charge to evaluate your situation.

Last week, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee of the FDA held public hearings the use of transvaginal surgical mesh for the repair of Pelvic Organ Prolapse (POP). As lawyers representing women adversely impacted by vaginal mesh and its use for POP, we want you to know the outcome of the first day of hearings. We will post separately on the second day of hearings that covered the use of vaginal mesh for stress urinary incontinence (SUI).

One the first day of the hearings, the views presented ranged from an outright ban on the use of mesh for this procedure, to the continued use of mesh, despite the adverse events that have occurred with its use. We have posted in recent weeks about these adverse events and complications women have suffered with the use of surgical mesh for these conditions.

The mesh manufacturers presented their point of view essentially stating (in summary) that the benefits of the use of mesh outweighs the complications. This group of presenters supported premarket clinical studies for new mesh products and postmarket studies to evaluate the long-term safety and effectiveness of mesh for POP repair. However, the manufacturers were not supportive of reclassification of the mesh to Class III which would also require premarket approval. One presenter that manufactures a porcine product for POP repair stated that their product does not have the vaginal erosion rates that synthetic surgical mesh has caused.

The FDA presented the findings it has gleaned from their databases and other sources, including an epidemiological review of the published literature and clinical data on the risk-benefit profile of mesh for POP repair. The FDA stated their conclusion that the use of vaginal mesh for POP repair in fact poses vaginal erosion risks and that the use of the mesh is questionable given the benefit of the alternative procedure, which involves surgical repair. They recommend that the risk-benefit analysis would be best evaluated through both premarket and postmarket clinical studies.

One of the most important results of these hearings is the FDA's recommendation that vaginal mesh should be reclassified from Class II (Special Controls) to Class III (Premarket Approval) which would result in designed clinical trials. This is something that in our opinion should have been done in the first instance, prior to the fast track approval of the use of synthetic mesh when there are much safer surgical procedures that do not include mesh.

The Advisory Panel consensus is significant in several areas. The panel consensus is that vaginal mesh safety in POP repair has not been well-established, that it may not be more effective than traditional repair methods, that the risk-benefits of mesh have also not been well-established and that studies are needed to evaluate the use of vaginal mesh for POP repair. The panel also reached consensus that the vaginal mesh should be reclassified to Class III. Postmarket studies are also recommended.

In addition to all of this, the panel noted that patient information such as labeling and informed consent as well as mandatory registration of mesh devices used in procedures, surgical training, education, and credentialing are all important components. The panel also suggested that the FDA work on coordinating data and collection of data for post market clinical information.

Hersh & Hersh has been at the forefront of litigation involving women's health for four decades. We have litigated landmark and historic cases involving medical procedures, defective devices and dangerous drugs that have adversely impacted women. If you have been injured by a procedure involving surgical mesh for POP or stress incontinence, please contact our law firm. We will consult with you free of charge to evaluate your situation.

When we first began writing about problems with transvaginal surgical mesh, it was difficult to find much about it on a Google or Bing search. We were one of the first law firms in the country to represent victims injured by surgical mesh and we continue to remain closely involved in this issue and litigating cases on behalf of our clients.

The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will be holding hearings that will be open to the public on the use of surgical mesh in women. The meeting will be held on September 8 and 9, 2011, from 8 a.m. to 6 p.m. in Maryland.

At these hearings, the committee plans to discuss the use of transvaginal surgical mesh and ultimately will make recommendations as to whether it is safe or effective to use this for pelvic organ prolapse repairs in women. We will be attending the hearings.

The purpose of these hearings is to secure the opinions of experts on both the risks and benefits, if any, in the use of mesh for POP and related surgeries. We are all now aware of the many reported and well-documented adverse events that have been submitted to the FDA. Such conditions and problems as vaginal erosion, pelvic pain and other serious effects will undoubtedly be reviewed.

After having approved the use of this device on a fast track. the FDA is now taking a closer look at whether it now must rectify its original haste to allow mesh use for these surgeries and may well reclassify the device to what is called a Class III (premarket approval) which would require more scrutiny, improving the labeling to ensure there is sufficient information and warnings about the use of mesh for female surgeries involving POP and other conditions, such as stress urinary incontinence, as well as closer study of adverse events and reporting.

We will report on the hearings and the resulting action, if any, by the FDA.

Hersh & Hersh has been at the forefront of litigation involving women's health for four decades. We have been involved in landmark and historic litigation involving medical procedures, defective devices and dangerous drugs involving women. If you have been injured by a procedure involving surgical mesh for POP or incontinence, please contact our law firm. We will consult with you free of charge to evaluate your situation.

Please do not suffer in silence. Contact our law firm to speak with a lawyer who will consult with you in complete confidentially. Even if your doctor recommended that you have the surgery with the use of transvaginal mesh, you may well be entitled to damages for any injuries or pain you are now experiencing as a result.

Earlier this month, we advised our readers that the FDA had issued a safety warning regarding the use of transvaginal surgical mesh in various surgeries for women suffering from conditions such as pelvic organ prolapse. The FDA's action was the result of thousands of women reporting serious complications with this implantable device.

In a recent article in the Chicago Tribune, that was also published by the LA Times, examples of the complications women have suffered have been reported in great detail. As personal injury lawyers representing women who have suffered from these complications, we are painfully aware of them. There are other ways for surgeons to correct medical conditions such as pelvic prolapse and patients must be very cautious in allowing a surgeon to insert surgical mesh transvaginally.

The recent press on these procedures appears to target the lack of training of some surgeons performing these procedures and using this device. And as is pointed out in the Chicago Tribune piece "the FDA hasn't required companies selling mesh products to prove they're safe or effective when used in the pelvis, even though the potential harm can be substantial."

We are well-aware of the serious medical consequences women have suffered when the mesh is used for pelvic prolapse and related surgeries. And once implanted, it is often difficult if not impossible to remove the mesh due to the development of scar tissue surrounding the device.

The renowned Mayo Clinic in Rochester, Minnesota and some other major clinics, will simply not perform these procedures using surgical mesh. They prefer to use other very viable ways to correct these issues through the abdomen.

But as reported in the Chicago Tribune, some doctors believe there are patients for whom this is the best alternative where anesthesia use can be a risk factor or for women with recurrence of prolapse. They seem to point to the surgeon's skill and training as the issue, rather than an inherent problem with the use of mesh in this context.

However, the FDA has had thousands of reports of complications. As injury lawyers who have helped women suffering from some of the excruciating and life-changing results of the use of transvaginal surgical mesh, we urge patients to talk with their doctors about the risks of the use of mesh.

While mesh may be a possible corrective device in other types of surgeries, such as hernia repairs, using this transvaginally may not be a risk that should be taken when the complications can be worse than the original condition. Clinical outcomes have not been shown to be better using surgical mesh -- this is something that all patients looking for surgical correction should consider.

As noted in the Chicago Tribune piece, the FDA is looking at various "regulatory options related to mesh, including reassigning products used in vaginal prolapse surgeries to Class III, the most tightly regulated type of device. Should that occur, companies would have to provide much more data about the products' effectiveness both before and after they come out on the market."

An FDA public hearing in September is expected to bring out many women who have suffered from the use of this device. The agency will be considering its fast track approval of the use of mesh for this purpose and could reclassify it, making it far more stringent for companies advocating its use in this context.

We urge women to contact our law office to discuss complications from the use of mesh in their surgeries. We will consult with you at no charge.

Nearly a year ago, we posted on the dangers of transvaginal implantation of surgical mesh, including the risks and complications associated with procedures for Pelvic Organ Prolapse or POP and Stress Urinary Incontinence or SUI. After thousands of women have been implanted with the surgical mesh transvaginally, the federal government now says, beware.

Today, in a stunning development, the U.S. Food and Drug Administration issued an update to their prior safety communication that warns both health care providers and patients that the transvaginal surgical mesh procedure used to repair POP could well "expose patients to greater risk than other surgical options" with no evidence that patients' quality of life will be improved by this procedure.

At the time we warned our readers about this last year, vaginal mesh manufacturers had already reported many complications to the FDA including infection, pain, vaginal epithelium erosion, urinary problems, and the return of conditions for which the procedure was performed. The FDA's 2008 safety communication was due to adverse events occurring to patients after the transvaginal placement of mesh. The numbers have continued to rise since that time. In our view, the procedure is not worth the potential pain and suffering that patients may endure.

Today's new safety communication does not surprise us. As injury lawyers representing women implanted with surgical mesh, we represent women who have had this procedure and are suffering from the consequences.

Some women have scar tissue that is so painful that cannot sit down without pain. Some women have chronic pain. Some women have suffered a severe blow to their quality of life, including their sexual, urinary and other functions. All of them should question why the federal government did not take this step sooner. We can only assume that a recall could well be issued in the future.

There is another way to correct POP that does not carry the risks associated with the surgical mesh implanted transvaginally. This method makes the repairs by going through the abdomen and using stitches. The FDA has now made it clear that there is "no evidence" that mesh provides "any greater clinical benefit than non-mesh surgeries."

Because the transvaginal correction carries risks, the FDA is now " 'asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.' "

And as we have noted, the complications from this procedure can be life-changing and severe. Once implanted, it can be very difficult to correct the problems that result from the implantation of the mesh, including removal of scar tissue as well as removal of the mesh.

The FDA recommendations for patients are:

1. Know the options and make sure that you understand why the surgeon is recommending the mesh procedure.

2. Get routine check ups and surgical follow-ups. Tell your doctor if you are having any abnormal bleeding, pain or other symptoms.

3. If you have had POP surgery, ask your surgeon whether mesh was used.

Outside experts will meet in early September to consider the use surgical mesh in the treatment of POP, as well as the risks of the transvaginal repair and the need for clinical studies.

Hersh & Hersh is a California consumer law firm that is dedicated to helping those injured by defective medical devices throughout the country. We are injury lawyers with decades of experience and expertise representing women harmed by defective medical devices, implantations and dangerous drugs. We have litigated landmark legal cases involving the protection of women and their health. We have been at the forefront of protecting women harmed by medical devices and drugs, including silicone breast implants, DES, IUD's and others.

If you or someone you know has had a transvaginal surgical mesh procedure and is experiencing complications, please contact our law offices immediately for a free consultation with regard to your medical and legal options.