Pennsylvania Injury Lawyer Blog

Is the FDA 501(k) Process to Blame for Transvaginal Mesh Complications?

Wed, 16 May 2012 00:16:20 -0500

As more info on pelvic prolapse surgery recall meshes is provided and more concerns about the safety of transvaginal meshes are raised, it is natural to wonder how transvaginal mesh devices got FDA approval in the first place.

Vaginal Mesh + FDA 510(k) Process

Vaginal mesh were approved for use in the United States through what is known as the 501(k) process. The 501(k) process allows new devices to be approved if the manufacturer can prove that the new device is substantially similar to a product that is already on the market. That means that the new product does not go through an independent review.

Even though some transvaginal mesh products that were used as a basis for future 501(k) approvals have been taken off the market, the other products are allowed to remain on the market. This has led some people to raise concerns about the 501(k) process. What do you think? Should the 501(k) process be changed?

Youth Soccer & Traumatic Brain Injury

Thu, 10 May 2012 11:13:44 -0500

Everybody loves school sports – promotes family fun, provides lots of exercise, and trends to soccer-mania. Soccer is among one of the sports, most prone to head injuries, traumatic brain injuries to be exact.

How can something like soccer that is so much fun and build character and sportsmanship put student athletes particularly girls at so much risk for potential brain injuries?

Athletes who often head soccer balls were found to have brain abnormalities similar to those found in patients with traumatic brain injuries according to the Radiological Society of North America. Repetitive heading can set off a cascade of responses that lead to brain cell degeneration.

There is compelling evidence that brain changes that look like traumatic brain injury as a result of heading a soccer ball with high frequency. Since soccer is the most popular sport worldwide and is played by children and teens, these findings should be taken into consideration in order to protect soccer players.

Enter the protective head gear sales. Will protective head gear protect youthful soccer players? Head injuries are the hot topic in youth athletics. Taking precaution to avoid head trauma are reaching beyond football and hockey.

Some states like Colorado have endorsed some of the nation's most stringent laws regarding concussions. As of January 2012, coaches are now required to bench players as young as 11 years old when believed to have a head injury. Players are required to have medical clearance before returning to the field. Also coaches must take free annual online training to recognize concussion symptoms.

Here are 10 ways to reduce soccer injuries.

Ban the DMAA Bomb

Wed, 09 May 2012 00:20:04 -0500

DMAA is abbreviated for dimethylamylamine, a speed-like ingredient found in supplements used to lose weight and build muscle.

One Harvard researcher is calling for a DMAA ban because DMAA can narrow blood vessels which in turn can lead to an increase in blood pressure, tightening of thechest, shortening of breath, and consequently, perhaps even cause a heart attack.

Dr. Pieter Cohen, an assistant professor at Harvard says this pharmaceutical chemical (DMAA) has absolutely no place in the supplement world. Cohen thinks there have been six years of inappropriate sales for something that should not have been there in the first place.

Dr. Cohen published a research letter on the subject of DMAA in the Archives of Internal Medicine, urging the FDA to recall DMAA products. Dr. Cohen says he has treated patients who have taken these supplements and considers DMAA more potent than ephedra, which was banned by the FDA in 2004.

Names for DMAA supplements include Napalm, Code Red, Jack3D, Nitric Blast just to name a few of the 200 offerings being sold in GNC, Vitamin Shoppe, and military base stores among other retail outlets.

DMAA has been called "natural" but that term is so abused and there's no proof that the ingredient is indeed natural. DMAA wasn’t previously approved as a supplement; it would technically be considered a drug and subject to more stringent oversight. Dietary supplements don't require approval before hitting the market.

Manufacturers of DMAA supplements have until May 9 to prove that DMAA is safe according to the FDA. Until the FDA says DMAA is not safe then it's business as usual. People using DMAA are urged to take the supplement according to directions.

Two soldiers died and both had used DMAA supplements.

Can Accidents be Caused by Hazardous Conditions on PA Roads?

Mon, 07 May 2012 11:31:35 -0500

Unfortunately, the answer is yes.

Not all accidents are the result of driver negligence or a mechanical failure. Some accidents do occur because of hazardous conditions on the road. Some of the potentially hazardous conditions may include:

Bad signage. Signs may be confusing, difficult to read or missing.
Potholes. Significant potholes can make an otherwise passable road treacherous.
Unsafe road designs. A road may lack guardrails, warnings of steep curves or adequate room for cars to pass.
Untreated roads. Ice and snow may be allowed to accumulate and may not be treated as it is on other roads.

If you have been hurt in accidents caused by hazardous roads in PA then you may be entitled to damages for your accident injuries. It is important to contact a Pennsylvania car accident lawyer as soon as possible so that a full investigation can be done before evidence of hazardous road conditions are fixed or otherwise disappear.

Across the Country, Attorneys Make Headlines with Distracted Driving Awareness

Fri, 27 Apr 2012 12:04:40 -0500

The United States Department of Transpiration as declared April National Distracted Driving Awareness Month. Over 800 Trial Lawyers throughout the United States and Canada are doing their part to spread awareness of this deadly issue.

These lawyers are donating their time and resources to take part in the End Distracted Driving (EndDD.org) Student Awareness Initiative, and will reach approximately 50,000 before the close of the school year. Because Distracted Driving Awareness Month falls in close proximity to prom season, a number of schools are requesting presentations in May and June, making the awareness initiative an even bigger success.

Teenagers have been the target of the Distracted Driving Awareness Initiative because they are the most at risk group to being injured or killed in an automobile accident. According to a study by AAA, 80% of teenagers admit to texting while driving. These young adults grew up with hand held technology and multi-tasking and many believe that their multi-tasking capabilities are no when driving than they are performing any given task.

While these presentations are aimed at changing the students behavior, The Distracted Driving Awareness is not limited the presentation to self awareness only. Distracted Driving is not a teen problem, it is an “everyone problem”. Students are being encouraged to change not only their behavior, but to encourage their parents, many of which drive distracted according to the students, to improve their behavior as well.

These lawyers and their mission to raise awareness not only reached North American high school students, but also the attention of the local media. Reporters through out the country have been doing human interest stories on these presentations, creating a ripple effect that is bringing distracted driving awareness to the masses.

Fosamax Length of Time for Side Effects

Sat, 21 Apr 2012 13:52:39 -0500

Many people have many questions about Fosamax and the serious side effects that may result from taking Fosamax.

Below, we will explain four important Fosamax timing issues:

Fosamax length of time for side effects is important to know. It can take years for Fosamax side effects to start. While you should be aware of the symptoms of potential side effects when you start the drug, it is important to not let your guard down as the years pass without incident.
Fosamax to clear from body takes how long? There is not yet conclusive evidence about how long it takes Fosamax to completely clear the body. However, it is important to know that Fosamax is designed to stay in the body long term and that how long Fosamax remains in body is important.
How long to take Fosamax should be discussed with your doctor. Some doctors are now recommended that Fosamax be stopped after five years because of potential complications. As always, it is important to talk to your doctor about your own risks and when you should stop taking Fosamax.

For more information about Fosamax and how it may affect your body long term, please talk to your doctor about the benefits and risks so that you can make an informed decision.

What do Philadelphia Depuy Recall Lawyers Do?

Sat, 21 Apr 2012 13:48:49 -0500

Philadelphia Depuy recall lawyers represent patients who have been hurt by bad hips or hips that fail. When a client contacts a Depuy hip implant attorney, the attorney will talk to the client, review medical records, and discuss legal options with the client. In some cases, a lawyer will recommend that a client file a lawsuit or join an existing class action lawsuit, to protect his or her rights to a potential recovery.

Once a lawsuit is filed, Depuy hip recall lawyers in Pennsylvania will fight hard for an injured victim’s just recovery. That recovery may include compensation for medical expenses, out of pocket expenses, lost income and pain and suffering, for example.

To find out whether or not you might have a case, please contact an experienced Philadelphia Depuy recall lawyer today for a free consultation.

RIP to a Philadelphia Original: Dick Clark

Wed, 18 Apr 2012 17:48:13 -0500

Was American Bandstand the original reality TV or a prelude to Dancing with the Stars?

The “stars” were everyday cool Philly kids who were good dancers and slick dressers. If you didn’t live in Philly, you wanted to go there; you wanted to be on the show; you wanted a glimpse of Dick Clark; and you wanted to rock and roll your heart out. You wanted to come from school and forget about doing chores or homework and just be left alone in your own little world to watch American Bandstand.

More than anything you wanted to be a “regular” on American Bandstand even though you lived nowhere near Philadelphia or Pennsylvania for that matter.

Dick Clark, the man behind all this magical music making for the Baby Boomer generation has died at 82. According to the New York Times article, TV producer and host Dick Clark died of a "massive heart attack" after a medical procedure at St. John's Hospital in Santa Monica.

What medical procedure?

America’s oldest living teenager suffered from Type 2 diabetes, a stroke, and heart disease prior to his death.

New Years Eve will never be the same again.

What brand of hip implant do you have?

Wed, 18 Apr 2012 06:23:12 -0500

Take an informal survey of friends and family who have had hip implants. Ask what brand of hip implant do they have? Most likely blank stares will be the answer. Some may know metal on metal, metal on polyethylene, or metal on ceramic hip replacements, but most will be unaware of the brand or model.

You can jog their memories with Stryker, DePuy, Zimmer, Pinnacle, Biomet, and Wright among others though no recollection comes to mind. Yet, if you ask what brand of contact lenses or dental adhesive they use – brands easily roll off the tongue. Why so? Perhaps, brand recognition occurs because the contact lenses or dental adhesive packaging is personally handled and rests in the medicine cabinet.

Would a patient who has had a hip implant actually know the brand? Would you know the difference between primary acetabular components and primary femoral components? The answer is most likely no, unless you have reviewed your complex medical records.

So, as hip replacement patients, when you hear on TV or read on online about all the hip implant complications, what can you do?

Taking stress urinary incontinence out of the closet

Mon, 16 Apr 2012 01:47:14 -0500

Women: Come out of the closet. You no longer need to die of embarrassment because of stress urinary incontinence (SUI).

When plucky, perky, gorgeous actress and model Lisa Rinna opts to be the spokesperson for Depends underwear – you know that this product is not your grandmother’s diapers and you have more options than risky vaginal sling surgery.

What is SUI? Stress incontinence is losing urine without meaning to during coughing, sneezing, laughing, lifting something heavy, or exercising. The sphincter pelvic muscles support the bladder and urethra. If the sphincter weakens, it’s unable to prevent urine from flowing when pressure is placed on the abdomen by coughing, sneezing, laughing, lifting, or exercising.

An average adult bladder can hold over 2 cups of urine. Before considering risky vaginal sling surgery – ask your doctor about pelvic floor muscle training, electro stimulation therapy, behavior modification, lose weight if overweight, prescribing some medications, stop smoking, and avoid alcohol & caffeine, are some alternatives.

Risks associated with SUI vaginal tapes or vaginal slings surgery:
Based on reports filed with the Food & Drug Administration, the most frequent complications include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including painful sexual intercourse.

Treatment for these various types of complications included additional surgical procedures (some to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

Would Depends underwear be as effective? That’s a question for you and your doctor to decide. It’s important to research and weigh the benefits vs. the risks of SUI vaginal tape surgery.

What Do Trans Vaginal Mesh Lawyers Do?

Tue, 10 Apr 2012 20:03:06 -0500

Trans vaginal mesh lawyers have one primary responsibility. That responsibility is to protect the rights of a woman who has been harmed after transvaginal mesh surgery.

When you contact a transvaginal mesh attorney, your lawyer will want to know what happened to you after your vaginal mesh surgery. If you suffered significant side effects and were not informed of the potential risks then you may be able to pursue a surgical mesh lawsuit.

A transvaginal mesh lawyer is on your side. Your lawyer wants you to get the recovery that you deserve and will actively pursue a settlement and/or litigation to help you get the relief that you deserve. To find out more about what a transvaginal mesh lawyer does and how an attorney might help you, please call an experienced lawyer today.

OxyElite Pro Deaths – Should You be Concerned?

Tue, 10 Apr 2012 19:59:00 -0500

If you take OxyElite Pro then it is important that you be informed of potential risks before you take the supplement. While it is still legal to buy DMAA containing supplements, such as OxyElite Pro, in the United States, the United States Army has expressed concerns about the safety of DMAA and is currently doing a review to determine whether it should allow the supplements to be sold on Army bases. The review comes after the death of two servicemen who allegedly took DMAA supplements prior to their deaths.

Are OxyElite Pro Deaths common? There is simply not enough information to answer that question yet. With OxyElite Pro and Jack3d taken off market on Army bases, we know that there is a concern and we know that supplement users should be aware of the Army’s concerns and take the necessary steps to protect their own health.

Difference between transvaginal mesh, slings/tapes

Fri, 06 Apr 2012 17:00:16 -0500

Which of these medical devices is causing you problems?

That would depend on which procedure you had to correct what problem. For instance, if you had surgery to correct pelvic organ prolapse (POP) – then your doctor would have used transvaginal mesh, also called a graft. If you had surgery to correct stress urinary incontinence (SUI) your doctor would have used a sling or tape.

However, for some reason, the catch all phrase transvaginal mesh has been deemed the culprit.

The mesh resembles a panty-liner in size and shape but is made from porous material to provide support for prolapse. The sling or tape is thinner, shorter, like a mini hammock to support the urethra. Transvaginal mesh is a more invasive surgery than a sling or tape.

Manufacturers of both these implants include Boston Scientific, CR Bard, AMS, Ethicon/Gynecare, just to name a few.

Actos, Is it Safe to Use After Bladder Cancer?

Sun, 01 Apr 2012 06:07:25 -0500

Actos is a popular drug to treat Type 2 diabetes. However, it is not without risks. While there is not yet a definitive answer as to why Actos causes bladder cancer, a connection has been made between the drug and the development of this dangerous disease.

Currently, Actos remains on the market in the United States despite adverse FDA reports on Actos drug. In August 2011, the Actos label was changed to recommend that the drug not be used in patients who have active bladder cancer. The label change also recommended that caution be used in patients who have previously had bladder cancer.

What does the label change mean for you if you have already had bladder cancer? Should you take Actos? Is it safe? It is important to talk to your doctor about your concerns and about how best to manage your risk of bladder cancer and your Type 2 diabetes so that you can make informed decisions about your health.

Moving into Distracted Driving Awareness Month

Tue, 27 Mar 2012 16:26:49 -0500

April is National Distracted Driving Awareness Month. With the increasing popularity of cell phones, texting and internet accessibility on our mobile devices, and the addiction to those devices, we are also seeing an unfortunately increase in the amount of deaths caused by drivers who cannot break from these devices while behind the wheel.

A recent report by the Governor’s Highway Safety Association, based on data supplied by all 50 states, shows that the number of 16 and 17 year old drivers killed in car crashes increased significantly in the first half of 2011.

Unfortunately teenagers and young adults in their twenties are the most at risk of being killed in a car crash.

Traditionally, groups such as Mother’s Against Drunk Driving (MADD) and Students Against Drunk Driving (SADD) have advocate on behalf of safe driving against the potential dangers of alcohol and drug use behind the wheel. With the increasing distractions resulting from the endless capabilities of our mobile phones and electronic devices, we are seeing an increase in organizations dedicated to raising awareness of the dangers of distracted driving among young people.

Some of the recent players in educating students against the dangers of impaired/distracted driving include NODD.org, EndDD.org, DopeItAndDrive.com, FocusDriven.org, KidsAndCars.org, and NOYS.org.