California Injury Attorney Blog

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.

As California personal injury lawyers, we deal with a wide variety of defective products and devices that have caused injury or death. Recently, we shared with our readers the FDA's safety warning concerning surgical vaginal mesh, which is implanted in women to correct various medical problems, but has been shown to have serious adverse consequences in many patients. And we are involved in the recent recall of DePuy's defective hip implants, representing clients who have been implanted with these devices.

Another major area of our injury law practice relates to dangerous or defective products that have harmed or killed children. Our law firm was at the forefront of the largest crib recall in the history of the country. We are always interested in safety improvements to all products, including those intended for children.

Earlier this month, the U.S. Consumer Product Safety Commission (CPSC) voted to approve a new safety rule for children's outerwear. The final rule covers certain outwear and other clothing with drawstrings around the neck or waist. These have been found to have a serious risk of entanglement in playground equipment and car doors.

Twenty-six children have reportedly died after a drawstring became tangled on a playground or in a vehicle door. These incidents include dragging hazards as well as strangulation hazards.

The agency issued guidelines for a voluntary industry standard in the late 1990's, and fatal accidents have declined. But unfortunately, there are still many non-compliant products on the market and the agency has recalled over 100 of these in the past four or five years.

In a related matter, the CPSC has settled with Macy's Inc., of Cincinnati, Ohio, which will pay a civil penalty of $750,000 for selling non-compliant drawstring clothing for children for a period of four years. Although Macy's denies knowingly selling recalled products or failing to immediately report the sale of non-compliant products, they apparently are willing to pay a price to close the matter with the agency. The settlement includes sweatshirts, sweaters and jackets sold at either Macy's stores, or stores owned by the company including Bloomingdales and Robinsons-May.

Retailers and distributors have specific reporting obligations under federal law to report information that supports "the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard or ban enforced by CPSC."

This particular hazardous group of products is still of concern to the CPSC. They want to know about incidents or injuries involving these products on an ongoing basis.

The injury lawyers at San Francisco, California's Hersh & Hersh, have represented victims harmed by defective medical devices and other products for over four decades. Please contact our law office for a free consultation regarding your situation with one of our trial attorneys.

As California trial and injury lawyers, we have litigated cases involving dangerous supplements and medications that have caused injury and even death. We have represented victims and families whose lives have been changed by dangerous products that have ultimately been recalled by the FDA.

In our view, public access to medical and health information can be a good thing. But is also a mixed blessing when consumers have access without sufficient information or clinical testing.

We cannot foresee the future of the use of mobile media devices and medical information, but the Food and Drug Administration has just published draft guidelines that might give us all an indication as to where things are headed.

It is not surprising that mobile applications are becoming more widespread in the medical and health fields. It is also not surprising that the U.S. Food and Drug Administration is now seeking public comment on its intention to oversee some limited medical and health mobile applications using their regulatory authority. The FDA's focus is narrow, but the development of guidelines in this area is another sign of the booming apps market and the regulation of medical and health information which has become more and more accessible to the public.

Quoting an outside source, the FDA notes the 500 million smart phone and other mobile device users will use a healthcare app in the next five years. Whether you use an app for fitness, calorie intake, diet guidance or other purposes -- these uses are on the rise.

Even physicians are now communicating with patients through email and can review test results, such as MRI's over mobile communications devices.

The director of the FDA's Center for Devices and Radiological Health (who is a physician and a lawyer) has noted: " 'The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery ... [o]ur draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended.' "

The FDA has issued a draft of the guidelines they propose which is very focused in scope to "a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices." This subset includes mobile medical apps that: are added to existing medical applications, such as those involved with diagnostic tools and medical professionals' communications; or those that actually enable the mobile device to become a medical or diagnostic tool, such as the use of a mobile device to detect heart rhythms.

To review the agency's in-depth draft guidance document, intended for software manufacturers, distributors and others regarding the FDA's intentions to apply its authority in this area please click here. The current view of the FDA is to apply its authority and regulatory requirements only to a subset of mobile medical applications noted earlier. However, as usage grows and consumers are drawn to these applications, it is possible the regulatory scope will broaden.

The California injury lawyers of Hersh & Hersh represent consumers in a wide-range of health and medical injuries, including medical devices and dangerous drugs. We are currently representing clients injured by transvaginal surgical mesh, DePuy Hip implants and Zimmer NextGen Knee Replacements. Please contact our law office for a free consultation with one of our trial lawyers.

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.