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 bloog 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.

 

J & J faces thousands of Risperdal lawsuits

More than 5,000 lawsuits have been filed against Johnson & Johnson for failure to warn doctors and consumers that Risperdal can cause boys to grow large breasts, a condition known as gynecomastia.

Risperdal Litigation

At least 1,500 Risperdal cases have been consolidated in Pennsylvania on behalf of individuals who allege the drug caused excessive male breast growth and other complications. Complex litigation with multiple plaintiffs takes time. First filed in 2010, Risperdal bellwether trials are currently underway in the Philadelphia Court of Common Pleas.

One case now before a jury was brought by a Risperdal user who was prescribed the drug off-label as an 11-year-old boy to treat symptoms associated with Tourette’s syndrome. The plaintiff, who required surgery to remove excess breast tissue that allegedly resulted from his use of Risperdal, claims that Johnson & Johnson and its Janssen Pharmaceutical unit made millions of dollars by improperly promoting unapproved pediatric use of the drug. The lawsuit also alleges the pharmaceutical companies did not adequately warn doctors and consumers about the association between Risperdal and the development of gynecomastia in boys.

Risperdal in the News

Overall, media coverage of this case has been sporadic at best. However, the Huffington Post has released a massive 58,000-word, 15-chapter “DocuSerial,” which casts a bright light on the far-reaching effects of Risperdal. As part of their extensive reporting, the publication released the following short film, entitled, “The Boy with 46-DD Breasts.” The documentary follows the story of Austin Pledger, who developed “large pendulous breasts” as a teen after he began taking the drug for autism at age eight.

 

The Boy With 46-DD Breasts from HuffPost Highline on Vimeo.

Jury awards $2.5 million in Risperdal lawsuit

Boys and young men who develop gynecomastia after taking Risperdal may be eligible to receive financial compensation for both physical and emotional injuries. In February 2015, Pledger was awarded $2.5 million after a judge declared J & J failed to warn the drug could cause breast development. While some Risperdal cases have gone to trial, others settle out of court. Although the terms are confidential, settlements typically include money for surgery, ongoing medical care and counseling.

UPDATE (11/9/15) – In the third bellwether Risperdal trial in Pennsylvania, a jury ordered Johnson & Johnson to pay $1.75 million to a Maryland man who developed female breasts while taking Risperdal. The plaintiff, who had been prescribed Risperdal off-label when he was 9-years-old to treat symptoms associated with autism, was awarded compensatory damages for disfigurement and mental anguish.

Do lawsuits hurt big pharma?

Damages are awarded in a civil lawsuit to “make the plaintiff whole.” In some cases, punitive damages are also awarded to punish the defendant and (hopefully) deter future misdeeds. Unfortunately, most lawsuits against pharmaceutical manufacturers don’t make any difference in how these behemoths do business. Why? Big pharma has very deep pockets, as evidenced by the following statement, which Johnson & Johnson filed with the Securities and Exchange Commission in 2013—a year when their pharmaceutical segment achieved sales of $28.1 billion.

In the Company’s opinion, based on its examination of these matters, its experience to date and discussions with counsel, the ultimate outcome of legal proceedings . . . is not expected to have a material adverse effect on the Company’s financial position.

So, it seems that although Johnson & Johnson—and many of the top pharmaceutical corporations—face thousands of expensive lawsuits, they’ll be just fine. Too bad the same can’t be said for the thousands of hapless victims of corporate greed.

 

Sources:

Brill, Steven. “America’s Most Admired Lawbreaker.” The Huffington Post, September 15, 2015.

Johnson & Johnson. 2013 Annual Report. New Brunswick, NJ: Johnson & Johnson, 2013.

Kristof, Nicholas. “When Crime Pays: J&J’s Drug Risperdal.” The New York Times, September 17, 2015.

Wasserman, Emily. “J&J slapped with 1.75M verdict in Risperdal breast growth case.” FiercePharma, November 10, 2015.

 

 

 

Hidden cancer risks for Hysterectomy and Fibroid Removal

womanpain-1

Uterine cancer is the fourth most common cancer in women in the United States and the most commonly diagnosed gynecologic cancer[1]. Prior to a hysterectomy or fibroid removal (myomectomy), the FDA estimates that approximately 1 in 350 women have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma.[2]

Stages of Endometrial (Uterine) Cancer

Undetected uterine cancer is frequently in Stage I, during which time, a woman could have no symptoms. However, shredding undetected tumors with a power morcellator can spread cancerous cells and upstage the disease. This “cancer seeding” can significantly worsen the patient’s long-term survival. After surgery, the cancer can progress from Stage I to Stage IV rapidly. Uterine cancer that has been upstaged by morcellation, such as leiomyosarcoma, is very aggressive. Some patients had the cancer spread to their spine or lungs. These tumors are difficult to treat, in large part because they are resistant to chemotherapy and radiation.

According to the American Cancer Society, endometrial cancer is staged based on examination of tissue removed during an operation. This is known as surgical staging, and means that doctors often can’t tell for sure what stage the cancer is until after surgery is done.

Stage I

The cancer is only growing in the body of the uterus. It may also be growing into the glands of the cervix, but is not growing into the supporting connective tissue of the cervix. The cancer has not spread to lymph nodes or distant sites.

Stage II

The cancer has spread from the body of the uterus and is growing into the supporting connective tissue of the cervix (called the cervical stroma). The cancer has not spread outside of the uterus. The cancer has not spread to lymph nodes or distant sites.

Stage III

The cancer has spread outside of the uterus or into nearby tissues in the pelvic area.

Stage IV

The cancer has spread to the inner surface of the urinary bladder or the rectum (lower part of the large intestine), to lymph nodes in the groin, and/or to distant organs, such as the bones, lungs, or the omentum (a layer of fatty tissue that covers and supports the intestines and organs in the lower abdominal area).

Hysterectomy and Fibroid Removal Power Morcellator Cancer Symptoms

Some symptoms that could signal upstaged cancer after morcellation, include:

  • Vaginal bleeding or spotting, between periods or especially after menopause
  • Vaginal discharge
  • Pelvic or abdominal pain or a mass
  • Pelvic or abdominal swelling
  • Weight loss
  • Nausea or vomiting

If tumors affect other organs or bones such as the spine, symptoms could include back pain or nerve issues.

In 2014, the FDA issued a black box warning against the use of laparoscopic power morcellators. If you had a minimally invasive hysterectomy or myomectomy (fibroid removal) call us today at 1-800-ELK-OHIO. You may be entitled to compensation.


 

Resources:

[1] U.S. Cancer Statistics Working Group. United States Cancer Statistics: 1999–2011 Incidence and Mortality Web-based Report. Atlanta (GA): Department of Health and Human Services, Centers for Disease Control and Prevention, and National Cancer Institute; 2015.

[2] U.S Food and Drug Administration. (2014, November 24.) Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication. Retrieved from http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm.