Our medical device lawyers here at Denena & Points are pleased that the FDA has finally recognized officially the risks of transvaginal surgical mesh repairs for pelvic organ prolapse (POP). We applaud Public Citizen’s petition for rigorous approval and testing processes on these medical devices. A careful review and approval process of any medical device before surgeons place it in your body could only be beneficial. The surgical mesh, which had been used fairly successfully for years to repair hernias, just doesn’t seem to be suitable to the more challenging task of POP repair.
Transvaginal surgical mesh repairs of POP have caused thousands of women severe pain and trouble as the mesh eroded or extruded through the vagina. But undoing a surgical mesh repair presents a daunting task. The surgical mesh designs encourage the growth of the patient’s own tissues through and around the surgical mesh. In a successful operation, this tissue growth could help anchor the mesh in place. In an unsuccessful operation, it makes it virtually impossible to extract the surgical mesh without substantial invasion of and trauma to the patient’s already weakened tissues.
And, guess what? This surgical mesh that has caused so many women so much pain didn’t even require testing and approval before it went out on the market and into their bodies. Indeed, this surgical mesh was implanted transvaginally into hundreds of thousands of women over the years with far less safety testing than your car’s airbag received.
That just seems wrong. The inequity derives from the method that the FDA uses to classify medical devices. Only a small percentage of medical devices, those thought to pose the highest risk (like some implanted cardiac devices) have to undergo any testing or approval at all. Even some cardiac medical devices go to market without testing.
But people are beginning to ask questions. More and more individuals and organizations are calling for more rigorous approval and testing of the medical devices that end up inside our bodies. Let’s hope these questions bring about the desired changes. As I age, I’m sure I’ll have need of various medical devices. When the doctors put these devices inside my body, I’ll want to feel secure that they’ve been carefully tested and found to be safe.
Prolapsed! The Boom has Finally Fallen on the Mesh of Controversies, Uncertainties and Obscurities Surrounding the Implantation of Surgical Mesh to Repair Vaginal Prolapse
People tend to expect miracles from modern medical science. My own observations lead me sometimes to feel that medical understanding has not, in real terms, advanced all that much since your local doctor was also the local dentist. And your local dentist was also the local barber.
Modern medical science tends to re-purpose its drugs and medical devices as the original patents run out. I once had a co-worker who came to work one morning in a shell-shocked condition. We thought the worst. But no. She had merely discovered that the special facial medication she had been using so devoutly had originally served as a topical medication for genital warts or some such condition. Until the patent ran out. Then the company re-purposed (and I believe re-patented) it as a topical medication for some ordinary facial condition. Perhaps it was acne. I don’t recall. But the experience has colored my approach to medicine and medications ever since.
Well, the surgical mesh used to repair vaginal prolapses originally saw decades of use in the repair of hernias. Patients reported problems with the medical device implantations for their hernias, but not to the degree they’ve been reporting them in their vaginal prolapse cases. And the mesh repairs showed a much greater rate of success with hernias than they’ve ever shown in relation to vaginal prolapse repairs.
Back in 2008, the FDA issued a mild warning with regard to mesh repairs for hernias. The warning did not really address the use of mesh on vaginal prolapse cases, because the FDA at that time apparently had concluded that complications in such cases were rare. The FDA had somehow decided that while the procedure might be risky for hernia patients, it wasn’t particularly risky for vaginal prolapse patients.
If you have had both a hernia and a vaginal prolapse, you may find that conclusion astonishing. If you have had one of these conditions, but only have a pretty good knowledge of the other condition, you’re probably still somewhat astonished. Well, so am I.
But the FDA finally saw the light. And in July 2011, the FDA issued a strong warning regarding the use of mesh medical devices in vaginal prolapse cases. Indeed, the warning basically recommends against using the mesh medical device implantation procedure unless the patient and doctor can’t find any viable alternatives. Take heed.
But you may have already undergone a surgical mesh repair for a vaginal prolapse. And that repair may have already failed. You may have prolapsed again. You may have pain and complications you hadn’t imagined. Well, the FDA warning also serves as kind of a wake up call that even the government sees surgical mesh implantations for your condition as a dangerous procedure using an inappropriate medical device.
So you may be eligible to pursue financial compensation for your suffering from those who caused it. If you need to gain some peace and some recompense after all your suffering, we can help. Just call. We offer you a free consultation in which we could discuss your situation, its complications, your options, and your possible outcomes. Call today; we’d like to help. We think maybe the FDA waited too long to take a strong position on the issue. And many people have been hurt in the meantime.
It’s Humbling, But Our Best Man-Made Surgical Mesh Just Doesn’t Have the Sort of Strength and Give to Replace Nature in a Vaginal Prolapse Repair (A Blog in Three Parts)
Have you ever skinned a deer? If you’ve ever skinned, cleaned and separated the cuts of meat on a deer, you probably learned a lot more about internal anatomies and how things are connected inside the body than you ever intended. In case you’re thinking that I’ve started to wonder far from my intended legal topic, let me clarify. I haven’t. But a better understanding on internal tissue connections can help you understand more about the issue I’m going to be addressing. That issue involves the medical procedures used to correct a Pelvic Organ Prolapse (POP), often known as a vaginal prolapse. And these procedures are all about tissue connections.
You may have seen the warnings issued by the FDA about transvaginal surgical mesh implantations. You may also have seen the call by Ralph Nader’s Public Citizen organization to ban the marketing of these surgical mesh devices until they can be properly tested and approved according to stringent standards. You may be one of the many American women affected by some form of vaginal prolapse. Or you may know someone, or even quite a few people, who have undergone prolapse corrective measures of some form.
If so, you know that prolapse occurs when the strength of interior connective/supportive tissues begins to fail, and a woman’s internal organs start to impinge upon or even protrude through the vagina. As many of you may already have occasion to know, vaginal prolapse causes many complications to the sufferer. These complications can include incontinence, painful and difficult urination or bowel movements, and painful sexual intercourse, among other things. Prolapse can change your life and severely restrict your options. You may have to limit your travels or activities to stay near a restroom. You may have to limit activities that expose you to long periods of standing. You may have to tell your significant other “no” more often than you would like.
When vaginal prolapse and its complications become quite severe, doctors often recommend implantation of a surgical mesh or a sling to hold up the internal organs as the woman’s own internal tissues once did. The implanted mesh or sling might relieve the pressure on the vaginal structures. Various materials might be used for the meshes or the slings. Surgical mesh implantations usually consist of artificial materials. Slings might consist of the patient’s own tissues taken from other bodily areas, or of “cadaver skin.”
The cadaver skin comprises treated and processed internal tissues (not necessarily skin, which is too “stretchy” to be properly supportive) that come from animal or human cadavers. Personal anecdotal evidence, as well as some statistics, suggests that cadaver skin slings might give severe vaginal prolapse sufferers better results than surgical mesh implantations. Surgical meshes have been used effectively for decades to teat hernias. But containing a hernia does not present the mesh with the same challenge as supporting a whole suite of internal organs for a prolonged period of time.
What I’ve been getting to here is that if you’ve had occasion to see internal anatomy up close (like within an unfortunate deer), you may have noticed that internal connective tissues that have not weakened are immensely strong. In fact, a layer of connective tissue sheathes and protects each muscle. This tissue connects the muscles to the rest of the body. The connective tissue holds all the parts of the deer together internally, and it takes a considerable amount of effort to separate this strong connective tissue from the muscles and other tissues to which it attaches.
Go to Part 2 for discussion of complications from vaginal prolapse surgical mesh implantations.
It’s Humbling, But Our Best Man-Made Surgical Mesh Just Doesn’t Have the Sort of Strength and Give to Replace Nature in a Vaginal Prolapse Repair (A Blog in Three Parts: Part 2, Continued from Part 1)
In case you’re wondering, I’m a Texan. Back in the day, hunting during official deer season provided the annual male bonding activity for many families. It’s less popular now, for which the deer are no doubt thankful. Anyway, I’ve never been one to shoot at anything that didn’t shoot at me first. So I never actually shot at a deer myself. (If, someday, the deer start coming out of the woods with rifles and “bag limits,” I may have to revisit this stance.)
But I had to accompany other family members on occasion to the annual hunt. And since I hadn’t shot anything myself, I had to bear the burden of a larger proportion of the deer dressing for the table to fully participate in the event. That’s why I know about connective tissues. I’ve had to learn the hard way.
And coming from this perspective, it makes me believe that there just isn’t any way yet for medical science to fully replace with artifice the strength and flex of natural tissue. And such natural strength, combined with a certain amount of “give,” seems to be what a patient with a severe vaginal prolapse case requires to adequately support the prolapsed internal organs without complications.
From a structural perspective, my view is that you might be able to produce the necessary level of support with a surgical mesh implantation only if you anchored it to an external support structure outside of the body. This would take the support stresses (mostly) off the internal body walls and organs themselves. For instance, if the patient was willing to wear a permanent belt on the outside (almost like those worn by workers who lift heavy objects all day long), and the surgical mesh sling was anchored to that belt maybe with strong eye bolts and nuts, I can see it working. But who would want to do that?
Part of my perspective may come from acquaintance with a few women with severe vaginal prolapse problems. Some of them have had to undergo corrective surgeries more than once as surgical mesh after sling after mesh have failed. And let me add that surgeries of all types have potential complications. Your age, immune system strength and overall heath condition can strongly affect your chances for succumbing to surgical complications.
Go to Part 3 for a final analysis of surgical mesh implantations as a solution for vaginal prolapse.
It’s Humbling, But Our Best Man-Made Surgical Mesh Just Doesn’t Have the Sort of Strength and Give to Replace Nature in a Vaginal Prolapse Repair (A Blog in Three Parts: Part 3, Continued from Part 2)
Now, surgical mesh implantations may represent one of the only available forms of potential relief available to women suffering from severe forms of vaginal prolapse. And the complications of a severe prolapse are debilitating enough that even with the medical shortcomings and potential complications and failures of a mesh, patients remain willing to take their chances on these medical device implantations. Surgical meshes and slings seem to provide enough relief to enough women that they remain valid choices for severe vaginal prolapse patients.
But having seen the consequences of repeated prolapse correction failures and surgical complications, I strongly concur with the FDA warnings that complications from surgical mesh implantations are not rare and that they expose patients to greater risks than traditional non-mesh repairs. We tend to agree with the petition of the Public Citizen organization that a rigorous testing and approval process should occur before these medical devices enter the market. Because while surgical mesh implantations currently provide some relief for some women suffering from severe vaginal prolapse, these medical devices simply aren’t good enough to be worth the risks of the complications for many patients.
Currently, these medical devices remain inadequate to the task for which they are designed. Medical technology can’t yet replace the strength of the internal connections that nature originally gave us on a regular and predictable basis. Surgical mesh implantations can actually make some patients worse off than before. And a failed device leads to yet another surgery and attempt at correction.
You may, in fact, know this better than I do. You may have personally experienced complications from a failed or inadequate mesh implantation. We understand the pain, embarrassment, and limitations to your life that continued vaginal prolapse problems can bring. And we want to help. If you’ve been injured by a surgical mesh implantation or its complications, and you continue to suffer, we might be able to help. As your medical expenses continue to mount, you may be feeling increasing pressure from your financial burdens as well as from your slipping internal organs. And we may be able to help you obtain relief and fair compensation for your long suffering.
Despite the importance of early and comprehensive brain-trauma rehabilitation, Texas is about to cut funds for this vital program.
Most health insurance policies do not cover comprehensive brain injury rehabilitation. This lack of coverage means that thousands of patients are discharged from hospitals with crippling brain injuires. These unfortunate folks are dispatched off to nursing homes or to languish in their beds at home. The first few months right after a brain injury are crucial to the injured person’s future because it is during these months that the brain is most conducive to healing, according to data from the National Institute for Disability and Rehabilitation
Research. Fully two-thirds of patients discharged from rehab hospitals after a typical stay of only 16 days get no further treatment, these studies indicate.
People that have suffered brain-trauma need intensive therapy. Without it, these patients will never regain full use of their limbs, their ability to use language, their emotional balance and the ability to do simple, daily tasks.
Hats off to Texas. Frankly, I was surprised to learn that Texas is one of the few states that mandates the major health insurers cover brain injury rehabilitation. As we all know, the majority of Texans do not have health insurance. Texas has been stepping up and paying for those that lack adequate health insurance for up to six months. Unfortunately, this program is facing a 75% budget cut because of the state’s fiscal crisis, according to Jane Boutte, President of the Brain Injury Association of Texas.
Obvioulsy there has to be give and take during any budget negotiation. But we must all ask ourselves if cutting programs that help some of the most vulnerable amongst us is the proper place to look for budget cuts.
If you, a loved one or a friend is struggling with a traumatic brain injury suffered in some type of an accident, give us a call. You will speak with an attorney that isBoard Certified in Personal Injury Trial Law by the Texas Board of Legal Specialization that has handled many brain injury cases. Both Chad Points andTony Denena are ready to go to work for you and get the compensation you need to get your life back.
Insurance Adjustors and Insurance Company Lawyers will jump all over anything to Wreck Your Accident Case. Take some time and study this site and certainly Download our Free Report so you can get all of the information you need to either hire your own attorney or deal with the insurance company directly.
1. Leaving the scene without making a police report.
The Board Certified Pearland Personal Injury Attorneys see this critical mistake all the time. If you have been in an accident call the police. Without a police report the insurance company is very unlikely to pay anything on your claim.
2. Failing to get the names and contact information of all witnesses.
After a wreck all of the people involved are excited, anxious, worried, nervouse and probably injured. The police officer is going to hear different versions of the same event and come to her conclusion as to how the car accident happened and which person is at fault for the car wreck. If you are injured you must tend to those injuries. If you can, you must get the names and contact information for all witnesses and let the police know who these people are!
3. Giving a recorded statement to the insurance adjustor of the other driver.
This can be a real case killer. DO NOT GIVE A RECORDED STATEMENT to the INSURANCE ADJUSTOR. Do not sign anything from the other insurance company either. You are under no obligation whatsoever to give a recorded statement to the insurance adjustor or to sign their documents allowing them to get your medical records and bills. At a minimum, spend some time on this webiste reading the information we have made available to you and request a copy of our FREE book and read it before speaking with any adjustor.
4. Not seeking immediate medical attention for your injuries.
If you are really hurt, you should seek medical attention. If you are injured, you are not going to heal on your own. Get yourself to the emergency room from the accident scene or follow-up with a doctor the very next day. Delaying treatment will only lessen the value of your case and cause you not to get full compensation for your damages and injuries.
5. Failing to tell your doctor all of your injuries and areas of pain.
The emergency room or your doctor’s office is not the time to play tough guy or tough woman. You need to fully describe all of your pain, injuries and problems associated with the wreck so that your doctor can properly diagnose you and develop a treatment plan. This one is associated with number 4 above.
6. Failing to follow the instructions of your doctor and therapist.
Unless you are a doctor, you are not a doctor. The logic of this statement seems self-evident, but so many people try and diagnose and treat themselves by not following doctor’s orders to the letter. Do not do this, it will wreck your case.
You may not need a lawyer, but in all frankness, you really should consult a lawyer to make that decision. At a minimum, read these 6 things that can destroy your Houston accident case and make sure that you use this information as part of the way you deal with the adjustors.
Many people know that a Galveston accident attorney can be a helpful force to have on their side. However, many people also do not know what is the best time to call these lawyers.
When you are injured in a Galveston car accident or a Galveston truck accident, you likely have extensive medical bills and other costs that pile up. You might be more hard-pressed to pay these bills if you cannot work, or suffer from the completely understandable instances of emotional suffering that can follow serious wrecks.
These costs can be even harder to accept if someone else caused the dangerous crash. In effect, you are expected to pay the consequences of someone else’s negligent actions, whether they were speeding, driving drunk or even fell asleep behind the wheel.
This is simply not fair. Luckily, Texas law entitles you to recover damages from an accident caused by a negligent driver. A Galveston accident attorney may be able to help you earn you financial compensation for your medical bills, ongoing care, lost wages and much more.
The Galveston accident attorneys at Denena & Points represent victims of:
If you or a loved one has been injured in any of these events, now would be the right time to call a Galveston accident lawyer. You can reach Denena & Points toll free at (877) 307-9500 to schedule your own free consultation.
The Galveston accident lawyers at Denena & Points have years of experience helping accident victims just like you. For more information about what your case might be worth, call us at (877) 307-9500.
The Centers for Disease Control and Prevention (CDC) estimate that 1.4 million people suffer from a traumatic brain injury (TBI) every year. According to the data compiled by the CDC, 50,000 die, 235,000 sustain severe injuries that require hospitalization, and 1.1 million receive treatment in an emergency room. The most common causes of TBI are falls, motor vehicle traffic accidents, being struck by or against a moving object, and assaults.
What Are the Symptoms of TBI?
Depending on the severity of a traumatic brain injury, the complications that result can be long-lasting. In the mildest cases, people suffer from headaches, nausea, fatigue, a decline in their ability to concentrate, and irritability. Moderate TBI may result in a state of confusion; permanent or temporary physical, cognitive, or behavioral impairment; seizures; and slurred speech.
The most serious form of TBI is categorized as severe. Severe traumatic brain injury can cause serious complications, even putting the patient in a coma or a vegetative state. Severe traumatic brain injury can also limit a person’s ability to speak or move. In some cases, a patient may only be able to move their eyes, even though they are awake and able to think.
Treating a traumatic brain injury can be expensive. If you, or your loved one, have sustained an injury that resulted in a TBI, you may be entitled to a damage award. Because traumatic brain injury often requires long-term medical treatment, a damage award may include compensation for past, present, and future medical expenses and lost wages, and an award for pain and suffering. A Houston injury attorney at Denena & Points can review your case to determine whether you have a legal claim. Call 713-807-9500 or 877-307-9500 for a free consultation