FDA taking action to protect women before using Essure contraceptive

After receiving thousands of complaints about Essure, the FDA has taken further action to restrict the sale and distribution of this form of birth control.

Essure is a permanent contraceptive device, manufactured by Bayer, and is implanted into the fallopian tubes. The device consists of two metal coils, which, when inserted, cause inflammation. Scar tissue develops in the fallopian tubes, eventually enough to block eggs that are traveling from the ovaries to the uterus.

Continue reading “FDA taking action to protect women before using Essure contraceptive”

Off-label use of breakthrough cancer pain drug linked to serious opioid addiction and death

subsys
Source: Subsys

Cancer patients who are receiving regular pain medication and management can sometimes still experience sudden, intense flare-ups called breakthrough pain.

Subsys, a fentanyl-based pain relief mouth spray, was developed by Insys Therapeutics and approved by the FDA to treat the condition. The drug delivers a painkiller mist 100 times more powerful than morphine for pain that can’t be addressed with other narcotics in the patient’s usual pain management medications. When used as directed, Subsys offers much-needed relief for cancer patients during intense breakthrough pain flares. Continue reading “Off-label use of breakthrough cancer pain drug linked to serious opioid addiction and death”

Opioid-Related Car Accidents Are On The Rise

The opioid crisis opioidis hitting Ohio especially hard.

Abuse of prescription painkillers like fentanyl and oxycodone, as well as heroin, has risen dramatically over the past decade:

In 2005:

  • Approximately 15,000 deaths in the United States
  • 500 deaths in Ohio

In 2015:

  • Approximately 33,000 deaths in the United States
  • 2,700 deaths in Ohio

Alarmingly, experts believe that opioid-related deaths across the United States may actually be underreported.

With masses of people hooked on opioids, all facets of life are affected. Continue reading “Opioid-Related Car Accidents Are On The Rise”

5 Things You Need to Know About Hernia Mesh

hernia meshPhysiomesh®, a surgical mesh commonly used in laparoscopic procedures to repair hernias, was recently withdrawn from the market. The products may be off the market, but anyone who underwent surgery prior to the withdrawal could still be at risk of suffering serious complications and injuries.

Here are five things you need to know about the hernia mesh withdrawal:

  1. Physiomesh was granted market entrance without clinic trials. The FDA prematurely approved the product based on its similarity to other mesh products already on the market.
  2. Ethicon, a subsidiary of Johnson & Johnson, voluntarily withdrew its Physiomesh products from the market in May following reports of severe complications and risks.
  3. Side effects and complications linked to the recalled hernia mesh products include organ damage, infection, chronic pain, migration or shrinkage of the mesh or a need for corrective surgery.
  4. Multiple types of flexible hernia mesh are putting patients at risk. Ten variations of the product in different shapes and sizes were used in procedures to prevent the reemergence of hernias.
    View the full list of affected Physiomesh products.
  5. If you suffered complications after a laparoscopic hernia surgery, you may be entitled to financial compensation. Elk & Elk is currently investigating hernia mesh claims related to surgeries that took place after March 2010.

If you know hernia mesh was used in your laparoscopic hernia procedure, but do not know the product code or type, we can help you find the answers to your questions.

Call 1-800-ELK-OHIO or fill out an online contact form for a free case evaluation.

Pelvic Organ Prolapse: What You Need to Know

What to know if you’ve suffered pelvic organ prolapse

Pelvic organ prolapse occurs when an organ, such as the bladder, Pelvic Organ Prolapsedrops from its normal position and pushes against the wall of other organs and tissue. Though it is an important medical issue to address, the device commonly used to treat this condition poses serious health risks to patients.

Why is transvaginal mesh dangerous?

When someone suffers pelvic organ prolapse, it is often treated using a transvaginal mesh implant. Also known as surgical mesh, this device can hold the bladder in place like a sling.

The mesh is causing major injuries, including infection, erosion of the uterus and perforation of other major organs. A plastic-like substance used in the mesh called polypropylene reportedly cuts through organ walls, causing severe bleeding, pain and infection.

One blogger claimed her physician told her the implanted mesh was covered with mucosa, a membrane naturally created within the body. The membrane on the woman’s device eroded away, leaving the exposed mesh touching the walls of other organs in her pelvis.

What can I do if I’m injured by surgical or transvaginal mesh?

You are not alone. More than 300,000 women underwent transvaginal mesh procedures. Many of the individuals who have pursued a lawsuit against the manufacturers of the mesh have obtained successful outcomes.

Victims of transvaginal mesh injuries could receive compensation to cover all medical bills, time missed from work and any other expenses resulting from their injuries. Let the attorneys at Elk & Elk represent your best interests.

It is important to remember that you will not be taking action against the doctor who implanted the mesh. The manufacturers of the mesh are the responsible parties, and have no relation to your physician in regard to the lawsuit.

For more information about the transvaginal mesh lawsuit, click here, contact us online or call 1-800-ELK-OHIO for a free, no obligation case consultation.

 

Fluoroquinolone Antibiotics Linked to Aortic Injuries

Recent studies* indicate that users of fluoroquinolone antibiotics, including Cipro®, Levaquin® and Avelox® are twice as likely to suffer from aortic aneurisms and tears of the aorta—the largest blood vessel in the body.

Last year, doctors wrote more than 26 million fluoroquinolone prescriptions to treat common infections. Unfortunately, these antibiotics have been linked to collagen degradation, which can weaken the aorta, causing it to bulge (aortic aneurysm) and split apart (aortic dissection). Damage to the aorta can lead to strokes, heart attacks, internal bleeding and death.

What are fluoroquinolones?

Fluoroquinolones are a group of wide-spectrum antibiotics, used to treat a variety of problems, including sinus infections, bronchitis and urinary tract infections. They include:

  • Avelox ® (moxifloxacin hydrochloride)         
  • Cipro ® (ciprofloxacin)
  • Cipro ® XR (ciprofloxacin)
  • Factive ® (gemifloxacin mesylate)
  • Floxin ® (ofloxacin)
  • Levaquin ® (levofloxacin)
  • Maxaquin ® (lomefloxacin hydrochloride)
  • Noroxin ® (norfloxacin)        
  • Proquin ® XR (ciprofloxacin hydrochloride)
  • Raxar ® (grepafloxacin hydrochloride)         
  • Zagam ® (sparfloxacin)        

How do fluoroquinolones damage the aorta?

Use of fluoroquinolone antibiotics has been associated with several collagen-related disorders, including tendon rupture, tendinopathy, and retinal detachment. In 2008, the USA Food and Drug Administration issued a black box warning for fluoroquinolones, indicating that these medications were associated with tendonitis and tendon rupture.

Collagen is also a major component of the aortic wall. Since fluoroquinolones have been known to degrade collagen, researchers began to question whether fluoroquinolones may cause or aggravate damage to the aorta, including aortic aneurysm and dissection.

A study by researcher Chien-Chang Lee, MD, of National Taiwan University Hospital and colleagues published in JAMA Internal Medicine found, “Use of fluoroquinolones was associated with an approximately 2-fold increase in risk of aortic aneurysm and dissection within 60 days of exposure.”

What is an Aortic Aneurysm?

The aorta is the largest blood vessel in the body. It carries oxygenated blood away from the heart to the rest of the body. Weakness in the aortic wall can cause it to widen and balloon outward, much like a damaged garden hose. In acute cases, the aorta can rupture and cause severe internal bleeding.

Warning Signs of Aortic Aneurysm

Unfortunately, many people with aortic aneurysms don’t know there’s a problem because they do not experience any symptoms. However, if the aneurysm becomes very large, it may cause pain, numbness, blood clots, or other symptoms. Affected areas vary, depending whether the bulge in the aorta is located in the chest (thoracic aneurysm) or abdomen (abdominal aortic aneurysm). A ruptured aneurysm causes a dramatic drop in blood pressure, sending the person into shock and damaging vital organs.

What is an Aortic Dissection?

An aortic dissection happens when the inner layer of the aorta tears, causing the inner and middle layers of the aorta to separate (dissect). This can lead to aortic rupture or decreased blood flow (ischemia) to organs. Aortic dissections most frequently occur in the upper (thoracic) part of the artery, but may also occur in the abdominal aorta. An aortic dissection may also cause aortic aneurysm. Symptoms of aortic dissection usually begin suddenly and include severe chest pain.

Sources:

Lee C, Lee M, Chen Y, et al. Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral FluoroquinoloneJAMA Intern Med. 2015;175(11):1839-1847. doi:10.1001/jamainternmed.2015.5389.

Daneman N, Lu H, Redelmeier DA. Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. BMJ Open 2015;5:e010077. doi:10.1136/bmjopen-2015- 010077

Jury awards $72M in J & J baby powder case

johnson&johnson-newsletterOn Feb 22, a jury in Missouri awarded $72 million in damages to the family of Jacqueline Fox, a woman who died of ovarian cancer after using Johnson’s Baby Powder for genital hygiene for decades. Fox was just one of thousands of women from across the country who filed claims against Johnson & Johnson for failing to warn consumers of the dangers associated with talc, the mineral used in baby powder.

During the trial, Fox’s attorneys presented a September 1997 internal memo from a J & J medical consultant, which criticized the company for claiming that studies at the time did “not demonstrate any real association” between talcum powder and ovarian cancer. The memo reads in part:

At that time [1994] there had been about 9 studies (more by now) published in the open literature that did show statistically significant association between hygienic talc use and ovarian cancer. Anybody who denies this risks that the talc industry will be perceived by the public like it perceives the cigarette industry: denying the obvious in the face of all evidence to the contrary.

The St. Louis Post-Dispatch reported that one juror, Jerome Kendrick, 50, found Johnson & Johnson’s internal memos to be very compelling. “They tried to cover up and influence the boards that regulate cosmetics,” Kendrick said. “They could have at least put a warning label on the box but they didn’t. They did nothing.”

How does talcum powder cause cancer?

Talc is a mineral that is one of the main ingredients in Johnson’s® Baby Powder and Shower to Shower. Like asbestos, talc is a silicate that has been studied in relation to cancer risk. Studies spanning more than three decades indicate that manufacturers of powders containing talc have failed to warn consumers of serious health risks. Researchers have found that when women apply baby powder in the genital area, talc fibers can migrate through the reproductive system to the ovaries. These fibers can cause the ovaries to become inflamed and affect the immune system, increasing a woman’s risk of developing ovarian cancer by as much as 30 percent.[1]

Ovarian cancer is often deadly

Although Fox initially brought the civil suit, her son took over as plaintiff following his mother’s death in October—just two years since her diagnosis. According to the American Cancer Society, ovarian cancer only accounts for about 3 percent of cancers among women, but it causes more deaths than any other cancer of the female reproductive system. Following the widespread media coverage of this landmark case, women across the country have grown worried about the link between talcum powder and ovarian cancer.

Thousands of women with ovarian cancer have filed talcum powder lawsuits across the country and Elk & Elk is actively pursuing new claims on behalf of victims and their families. If you have been diagnosed with ovarian cancer and have questions about talcum powder, contact the experienced attorneys at Elk & Elk for a free, confidential case review.

The case is Hogans et al v. Johnson & Johnson et al, Circuit Court of the City of St. Louis, Missouri, No. 1422-CC09012.

 


Source:

[1] A 2013 study indicated that women who use powder containing talc in the genital area have a 20% to 30% higher risk of ovarian cancer than those who do not. (Terry KL, Karageorgi S, Shvetsov YB, Merritt MA, Lurie G, Thompson PJ et al. Genital Powder Use and Risk of Ovarian Cancer: A Pooled Analysis of 8,525 Cases and 9,859 Controls. Cancer Prev. Res. 2013;6:811-21.)

 

Essure Birth Control Under Fire

iStock_000013959692XSmallUPDATE (2/15/16) Elk & Elk is now actively pursuing legal action for victims of Essure. Call 1-800-ELK-OHIO for a free consultation.

Facing a wave of public criticism, Bayer has agreed to add warnings to the patient information booklet for Essure – a permanent birth control device consisting of coils inserted into a woman’s Fallopian tubes. The new language includes warnings of pelvic pain and device migration.

On the market since 2002, the device has been implanted in nearly 1 million women worldwide. Promoted by manufacturers as cheaper and less invasive than traditional tubal ligation, the Essure system has become a source of irritation for both Bayer and patients, with over 3,000 women speaking out about adverse reactions to the implants on social media sites.

According to news reports, a majority of the women are experiencing side effects from an allergy to nickel, which is a component of the coils. Originally, doctors were advised to test women for nickel allergies before implanting the Essure coils, but the manufacturer asked the FDA to remove that requirement a few years ago.

Other women complain of extreme bloating, skin rashes and headaches. Photos posted include broken coils that had been removed and X-rays of coils that perforated the fallopian tubes.

Reporting is crucial

Despite the growing anecdotal evidence regarding alleged risks associated with Essure, the FDA can only respond to official reports of serious adverse events. Even if you have spoken to your physician, it does not guarantee a report has been filed. If you wish to file a report, you can complete the paperwork yourself or ask for assistance from a friend, family member, or healthcare professional.

Adverse Events

According to the FDA, an adverse event is “any undesirable experience associated with the use of a medical product in a patient.” If an event is serious, it should be reported to the FDA. Examples of serious adverse events include, but are not limited to, death, life-threatening effects, hospitalization, disability or permanent damage, birth defects, and other important medical events.

For more information about reporting adverse events or to file a report online, visit the FDA’s MedWatch website.

You can also download instructions with the Consumer-Friendly Voluntary Reporting Form (PDF – 1.2MB).

 

NOTE: This blog was originally posted in November of 2013 and has been updated to include new information.

 

Source:

“Bayer changes Essure patient booklet to include health warnings on its birth control” by Lauren Gilger and Maria Tomasch, ABC, November 12, 2013.

Massive IVC Filter Study Underway

The Surgeon General estimates about one half million Americans are affected by blood clots annually and between 100,000 and 180,000 people die of pulmonary embolism (PE), a blood clot that travels to the lungs. To combat this problem, doctors implant hundreds of thousands of Inferior Vena Cava (IVC) filters inside patients each year to stop blood clots before they reach the lungs. Retrievable IVC filters have been reported to cause serious injuries if left in the body too long, however some physicians fail to remove the filters once the threat of pulmonary embolism has passed.

PRESERVE Study Investigating IVC Filter Safety

IVC filters have been linked to catastrophic injury and death.In August of 2010, the FDA issued a medical alert, warning that retrievable IVC filters can move or break, causing serious injuries, prompting researchers to begin investigating the devices. In 2014, the FDA issued an updated safety communication and in 2016, a study entitled, Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) began enrollment. The IVC Filter Study Group Foundation, sponsored jointly by the Society for Vascular Surgery (SVS) and the Society of Interventional Radiology (SIR), oversees the project. Over the course of the five-year study, 2,100 patients are expected to participate through 60 different medical sites around the U.S. 

“Our foremost commitment is to patient safety, and this study will help determine how well filters prevent pulmonary embolism and how they function over the course of their implantation,” said Matthew S. Johnson, Fellow of the Society of Interventional Radiology and professor of radiology and surgery at Indiana University School of Medicine.

According to the PRESERVE website, the study is unusual because, “More typically, studies follow one or two devices. Studying filters produced by seven different manufacturers at once is an enormous undertaking. The trial will follow 300 patients per device.”

Participating Manufacturers:

  • ALN Vena Cava Filter – ALN Implants Chirurgicaux
  • Option™ Elite Retrievable Vena Cava Filter – Argon Medical Devices, Inc. (designed and manufactured by Rex Medical)
  • VenaTech® LP Vena Cava Filter – B. Braun Interventional Systems Inc.
  • Cook Günther Tulip Vena Cava Filter – Cook Incorporated
  • DENALI® Vena Cava Filter System – CR Bard Peripheral Vascular, Inc.
  • Cordis OptEase® Retrievable Vena Cava Filter – Cordis Corporation
  • Cordis TrapEase® Vena Cava Filter – Cordis Corporation
  • Crux® Vena Cava Filter System – Volcano Corporation

“The treatment of deep vein thrombosis in trauma patients has challenged physicians to know the best way to take care of those patients,” said co-principal investigator Dr. David Gillespie, chief of vascular and endovascular surgery at Southcoast Health System, Fall River, Mass. “There are a lot of devices from different manufacturers to choose from. Physicians have been using the retrievable filters with the idea they will retrieve them, but for many reasons they often don’t.

IVC filter lawsuits  

Patients from across the country who were harmed by IVC filters have begun to file lawsuits against device manufacturers, seeking compensation for their injuries. Sadly, some family members of IVC filter patients filed a wrongful death claim as a result of the dangerous device.

IVC filters: 4 things you should know

Each year, doctors implant about a quarter of a million IVC filters into patients at risk for blood clots. New studies have revealed serious dangers associated with these devices.

Doctors usually treat blood clots with an anticoagulant, also know as a blood thinner. However, blood-thinning medicines are not safe for some people. If you are at risk for a pulmonary embolism (blood clot in lungs) your doctor may implant an inferior vena cava (IVC) filter. IVC filters are devices placed into a large vein in your abdomen to catch blood clots.

Unfortunately, IVC filters have been associated with catastrophic injuries. If you have a blood clot filter, you should discuss the following topics with your doctor.

Top 4 facts about IVC filters

  1. The longer an IVC filter remains, the higher the risk of injury. Once a patient’s risk for blood clots has passed, retrievable IVC Filters should be removed — between 1-2 months after implantation. Long-term risks associated with IVC filters include lower limb deep vein thrombosis and IVC occlusion. In one study, only 8.5 percent of IVC filters were successfully removed.[1]
  2. The device is connected to 27 deaths. A recent NBC investigative report revealed that at least 27 deaths have been linked to IVC filters. According to the news outlet, “Serious questions are being raised about [IVC filters] implanted in thousands of Americans at risk for blood clots — including whether the manufacturer told all it knew about potentially fatal flaws.”
  3.  The FDA has received many reports of serious injuries. The device can migrate, fracture, move to the heart or lungs, perforate and be difficult to remove. These injuries may be related to how long the filter has been implanted.
  4. A new study suggests that IVC filters do not provide any medical benefit. “High rates of prophylactic IVC filter placement have no effect on reducing trauma patient mortality and are associated with an increase in DVT events.”[2]

The medical device attorneys at Elk & Elk are investigating claims involving IVC filters. If you had any retrievable IVC filter implanted after 2002, call 1-800-ELK-OHIO today. You may be eligible for compensation.


 

References

[1] Sarosiek, Shayna, Mark Crowther, and J. Mark Sloan. “Indications, complications, and management of inferior vena cava filters: the experience in 952 patients at an academic hospital with a level I trauma center.” JAMA Internal Medicine 173.7 (2013): 513-517.

[2] Hemmila, Mark R., et al. “Prophylactic Inferior Vena Cava Filter Placement Does Not Result in a Survival Benefit for Trauma Patients.” Annals of Surgery, 262.4 (2015): 577-585.