FDA warning on uterine device draws opposition from doctors | Newsday

Nearly 50 doctors across the United States sent an open letter to the U.S. Food and Drug Administration on Monday calling on the agency to “revise or rescind” its position on a controversial device that had been used on more than 50,000 women annually until the agency cautioned against it last year.

The device, known as a laparoscopic power morcellator, had been widely used to remove benign growths known as fibroid tumors from the uterus or to completely remove the uterus itself in a hysterectomy.

Serious concerns arose, however, when deadly cancer cells harbored in the fibroids of some women were dispersed throughout the abdomen once shredded by the blades. Some fibroids hide rare and dangerous leiomyosarcomas, an aggressive cancer that can prove difficult to treat.

Source: FDA warning on uterine device draws opposition from doctors | Newsday

Advertisements

Providing Local Representation to Out-of-State Motorists

As summer fast approaches, many see this time of year as an opportunity to escape the cold weather being suffered in the northern states, squeeze in a vacation, or are burdened with traveling for work as business begins to increase. Unfortunately, this also means that our state highways and interstates are packed with such travelers. Increased traffic plus high speeds can often lead to disastrous results. The coastal region of Georgia in not only unique in that it attracts a healthy portion of those travelers, but it is also home to a stretch of interstate 95 that has unfortunately earned a reputation for high speeds and tragic accidents.

Often those accidents involve out-of-state motorists who now find themselves injured and away from their home venue. This feeling can be quite uncomfortable, leaving some feeling helpless and questioning what they can possibly do to be made whole again. Fortunately, the laws of the state of Georgia provide that an injured party can seek to bring a claim in the venue in which they were injured. However, an injured party is unlikely to be familiar with some of the local customs, laws, and surroundings areas. Seeking out local representation is beneficial because more often than not, the majority of witnesses, medical providers, critical evidence, and possible parties involved in the accident are located in that venue.

This is where our firm can help. We pride ourselves in not only providing excellent legal representation to our local community, but also representing out-of-state parties injured locally. We seek to provide representation that allows you to return to your regular life at home, while we take care of your interests here in Georgia.

If you are involved in an accident in Georgia, but are unsure how your out-of-state residency effects your case, please give us a call.

FDA Alert: RegeneSlim Appetite Control Capsules: Recall – Presence Of DMAA

 FDA Warning

ISSUE: Regeneca Worldwide a division of VivaCeuticals, Inc., is conducting a voluntary nationwide recall of its appetite controldietary supplement, lot # EX0616R15814 and lot #11414RE5516, because FDA analysis confirmed the presence of DMAA. DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA has warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.

via FDA Alert: RegeneSlim Appetite Control Capsules: Recall – Presence Of DMAA.

Some Doctors Ignoring FDA Advice to Stop Using Power Morcellators

FDA Warning

The Wall Street Journal (5/22, A1, Levitz, Kamp, Subscription Publication, 5.51M) reported that the FDA has discouraged Doctors from using power morcellators to remove uterus and uterine fibroids.  The agency had warned against using the procedure because of concerns it could accidentally spread cancer to other parts of the body.

A morcellator is a surgical instrument used for division (“morcellation“) and removal of large masses of tissues during laparoscopic surgery

This comes in the wake of Johnson & Johnson suspending worldwide sales its power morcellators on April 30, 2014.

If you have to to undergo laparoscopic surgery for removal of uterus and uterine fibroids, make sure you confirm with your doctor that he/she is not planning on using a power morcellator.

Nathan T. Williams

TheWilliamsLitigationGroup.Com

Removal of Faulty Mesh May Not Solve Women’s Problems

In the 1990’s, doctors began using mesh implants to give extra support to a woman’s organs after organ prolapse surgery.  Shortly after surgeons began using these mesh implants, the FDA began receiving a large number of complaints and problems attributable to the mesh. Most of these problems involved infection, mesh erosion, bleeding and pain.  In April 2014, the FDA reclassified many mesh implants as “high-risk” and stated it would now require stricter oversight of the products.

Many injured patients have taken their cases to court. There are currently over 49.000 pending federal lawsuits against seven different mesh manufacturers. The manufacturers with the most cases are American Medical Systems, Ethicon, Boston Scientific, C.R. Bard, Coloplast, Cook Medical and Neomedic.

Now, it has been reported that removal of the faulty mesh may not improve patient’s symptoms.  A study of 214 women conducted by the University of California found that 1/3 of women who had the mesh removed still experienced moderate to severe pain.  It also found that 28% of those women still experienced urine leakage on a daily basis and pain during sex.

At this point, it appears that many women will continue to suffer from mesh implants long after removal.

Please let us know if you or someone you love has experienced any problems with vaginal mesh implants.  We can help.

Nathan T. Williams

Pradaxa (dabigatran): Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

New FDA Medwatch Alert
May 13, 2014
Pradaxa (dabigatran): Drug Safety Communication – Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin

 

Audience: Cardiology, Patient, Pulmonology, Internal Medicine, Orthopedics, Neurology.
ISSUE: The FDA recently completed a new study in Medicare patients comparing Pradaxa to warfarin, for risk of ischemic or clot-related stroke,  bleeding in the brain, major gastrointestinal (GI) bleeding, myocardial infarction (MI), and death. The new study included information from more than 134,000 Medicare patients, 65 years or older, and found that among new users of blood-thinning drugs, Pradaxa was associated with a lower risk of clot-related strokes, bleeding in the brain, and death, than warfarin. The study also found an increased risk of major gastrointestinal bleeding with use of Pradaxa as compared to warfarin. The MI risk was similar for the two drugs.

Does your hip hurt months or even years after being replaced?

Many companies that manufacture modular hip replacements have been under fire by consumers for making and promoting hip replacements that are prone to failure and other serious side effects.  The manufacturer of Stryker® Rejuvenate and ABG II hip implants has been the target of over 700 lawsuits since 2013.  Our firm, The Williams Litigation Group, is currently handling these cases.

Stryker® Rejuvenate and ABG II modular hip implants were introduced to the market in 2009 after receiving FDA approval through the 510(k) approval process. Between 2009 and 2012, an estimated 20,000 patients received Rejuvenate or ABG II hip implants.

How are they different from traditional hip implants?

Stryker’s Rejuvenate and ABG II hip implants differ from metal‐on‐metal hip implants. Rejuvenate and ABG II hip implants use a ceramic cup as opposed to the metal‐on‐metal ball and cup design which has plagued other hip implants. Due to the ceramic cup, Stryker’s Rejuvenate and ABG II modular hip implants were originally believed to be immune from the defects caused by the metal‐on‐metal wear. Unfortunately, Rejuvenate and ABG II implant metal neck piece can rub against the metal stem causing the release of metal debris and implant fretting, galvanization, and corrosion.

What kind of problems or side effects can they cause?

Patients have experienced a host of problems from the Rejuvenate and ABG II hip implant corrosion and fretting. Soft tissue damage and destruction are common, as are increased levels of chromium, cobalt and titanium, which can lead to metallosis. Metallosis, the adverse reaction to heavy metals in the body, can result in pain, limited mobility, failure of the hip joint, pseudo‐tumors, and dissolution of the bone. Revision surgery is often required.

Stryker’s notice to patients and recall:

In April 2012, Stryker issued an Urgent Field Safety Notice to surgeons and hospitals, acknowledging it had received reports of device failure. This notice specifically referred to failures of the taper neck junction between the neck and stem due to corrosion and fretting and complications including tissue necrosis, metallosis, adverse soft tissue reaction, and pseudotumor formation.

Stryker initiated a voluntary recall of the Rejuvenate Modular and the ABG II modular hip stems in June 2012. Stryker reported that the recall was due to the risks associated with the modular neck stems, including fretting and corrosion of the neck junction, adverse tissue reaction, and pain or swelling of the hip.

Do you or a loved one have a Stryker hip implant?

If so, and you are experiencing pain or weakness, please call us or fill out the below Contact Form for a free consultation.  You may be entitled to compensation.

Nathan T. Williams

Williams Litigation Group, P.C.

912-264-0848

TheWilliamsLitigationGroup.Com

How Common are Pharmacy Errors/

Very. You should check every prescription you have filled to confirm that you have the correct medication – this especially true with your children’s medication. Many chain pharmacies (CVS, Walgreens, etc.) actually have a “pill identifier” label on the outside of the bottle. This label describes the shape and color of the pill that is supposed to be in the bottle. Some chain pharmacies (i.e. Wal-Mart) don’t currently provide this label. You should always confirm that both the label on the outside of your bottle is correct as well as the shape, size, and inscription on the pill is correct. There are many websites which provide pill identifier services that allow you to type in the name, shape, size, and inscription of the medication to confirm you have the right meds. You should be mindful that the same generic drug can often change shape, size, color, and/or inscription depending on the generic manufacturer. You should ALWAYS confirm with your pharmacist any time your medication changes in any way.

We recently represented a client who had received the wrong medication from Wal-Mart and almost died after taking it for a period of time. To say that it was frightening to learn what Wal-Mart’s corporate policies on its pharmacists confirming the right pills were in the right bottle is an understatement. We were fortunately able to obtain a substantial jury verdict on the client’s behalf.

In a nutshell – pharmacies, especially chain/volume providers, are WAY more concerned in filling as many prescriptions as humanly possible than they are on ensuring the correct medications are being provided to their patients. So, pay close attention to your medications because they aren’t.

Nathan Williams
http://www.TheWilliamsLitigationGroup.com