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.

Sebring Lead Crisis: 11 More homes test positive, village cited

The Ohio Environmental Protection Agency has announced the latest water samples taken by the village of Sebring revealed elevated lead levels in the tap water of 11 homeowners who asked for their water to be tested. The state agency said that 34 of 698 samples taken in Sebring since January 21, 2016 have showed lead levels above the federal allowable level of 15 parts per billion.

EPA Cites Sebring for Failing to Warn Residents

On February 9, the Ohio EPA issued yet another Notice of Violation to the village for failure to communicate recent test results and guidance to homeowners and failing to submit its required weekly report on water chemistry.

“When EPA staff followed up this weekend to conduct cautionary testing on a few homes that tested above the federal allowable level, it became evident that the village had not notified these residents of their recent test results as quickly and thoroughly as they should have,” Ohio EPA Director Craig Butler said in a press release. “I expect the village to keep the public in mind and provide prompt information to its residents.”

Earlier this year, the Ohio EPA barred James V. Bates, the operator of the Sebring water treatment plant, from operating any water treatment system in Ohio and initiated steps to revoke his license. Amid accusations of negligence, the agency opened a formal investigation of Bates to determine if he endangered public health by falsifying reports. Bates has publically denied the allegations.

Lead: Flint and beyond

In the wake of widespread media coverage of Flint’s disastrous response to lead-tainted water, lead has garnered national attention. On February 9, a New York Times article discussed the pervasiveness of elevated lead levels in the tap water of communities across the country – highlighting the village of Sebring:

In Sebring, Ohio, routine laboratory tests last August found unsafe levels of lead in the town’s drinking water after workers stopped adding a chemical to keep lead water pipes from corroding. Five months passed before the city told pregnant women and children not to drink the water, and shut down taps and fountains in schools.

Due to corroding pipes, lead began to leach into Sebring tap water. The Department of Health offered free blood screening and confirmed that six people, including five children, had elevated lead levels. Although no safe blood lead level in children has been identified, according to the CDC, experts now use “a reference level of 5 micrograms per deciliter (μg/dL) to identify children with blood lead levels that are much higher than most children’s levels.”

EPA Warning: Lead is stored in the bones

Although most homes are now testing within allowable levels, for some Sebring residents, the damage has already been done. In a letter to Sebring residents, the state EPA offers this chilling warning:

Lead can cause serious health problems if too much enters your body from drinking water or other sources. It can cause damage to the brain and kidneys, and can interfere with the production of red blood cells that carry oxygen to all parts of your body. The greatest risk of lead exposure is to infants, young children, and pregnant women. Scientists have linked the effects of lead on the brain with lowered IQ in children. Adults with kidney problems and high blood pressure can be affected by low levels of lead more than healthy adults. Lead is stored in the bones, and it can be released later in life. During pregnancy, the child receives lead from the mother’s bones, which may affect brain development.

How long does lead stay in the body?

Lead can be absorbed by different parts of the body, where it remains for varying times:

  • 35 days in blood
  • 40 days in soft tissues
  • 3 to 4 years in trabecular bone (Also known as cancellous or spongy bone, trabecular bone is found at the ends of long bones, as well as in the pelvic bones, ribs, skull and the vertebrae in the spinal column.)
  • 16 to 20 years in cortical bone (Cortical bone forms the outer shell of most bones and makes up about 80 percent of your skeletal mass. It is much denser than trabecular bone, harder, stronger and stiffer.)

Lead affects the brain and nervous system, reproductive capabilities, the kidneys, the digestive system and the ability to make blood.

Residents exposed to lead who are concerned about the health of their family and protecting their legal rights should contact an experienced Lead Poisoning Attorney for a case evaluation.

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.

Avoid having surgery during the summer: What Ohio hospitals aren’t telling you

by R. Craig McLaughlin

It’s the championship football game and your favorite team is driving down the field to score a touchdown. Your star quarterback and seasoned offensive linemen are working together like a well-oiled machine. Everyone is in perfect sync and the entire team is seemingly moving as one. Your team can’t be stopped.

But wait! What’s this? A time out is called and in come a slew of substitutions. Your veteran quarterback and linemen are replaced by a rookie and four other practice squad players, who are being asked to play positions they have never played before.

For the rest of the game, lack of experience, unfamiliarity with each other and poor communication between the players lead to sacks, turnovers and a loss for your team.

Would the fans ever tolerate a change in personnel like this during the middle of an important game? No way!

But this is exactly the type of substitution that happens at Ohio’s teaching hospitals every summer and it puts patients at risk.

The most dangerous month for surgery

Every July, at teaching hospitals like The Cleveland Clinic, Ohio State University Hospital and Cincinnati Children’s Hospital Medical Center, there is a change of health care providers that threatens the safety of the patients at these facilities.

This is when the most experienced residents graduate and leave the hospital. These graduating residents have spent the past three to six years training under the guidance of more experienced doctors and the patients at these teaching hospitals served as their case studies.

However, these experienced residents are replaced by brand new doctors who just graduated from medical school. To compound the problem, the remaining residents who have been at the hospital for a year or two are now being asked to assume new and unfamiliar roles. Consequently, this can be a very dangerous time for patients at these teaching hospitals.

A medical team performing an operation
Do you know which month is most dangerous for surgery?

This is such a dangerous time of year for patients that studies show the rate of patient deaths and complications from medical procedures increases between 8% and 34% during the month of July.

Dr. John Young of the University of California, San Francisco, reported these findings in a study he published in the Annals of Internal Medicine. Every year this “July effect” – as the hospitals sometimes refer to it – affects about 100,000 doctors in teaching hospitals around the country. According to Dr. Young, no other industry undergoes such a dramatic change in personnel on such a regular basis.

Steps for a safer medical operation

So what can you do to protect yourself and your family members? Here are three tips from an experienced Ohio medical malpractice attorney:

1. Ask your doctor if he or she will be performing your surgery at a teaching hospital where doctors in training may be involved in your care. Some hospitals are not teaching hospitals or your procedure might be performed at a surgery center that does not use residents. If that is the case, then you likely won’t be affected by this problem.

2. If your surgery is elective and it is safe for you to put it off, request that your surgery be scheduled during the first six months of the year. At that time, the doctors being trained at a teaching hospital will be more experienced and familiar with the hospital’s policies, procedures and nursing staff, and there will be less of a chance for a mistake to be made.

3. If you have to have your surgery during the summer months because it can’t wait, let it be known that you want the most experienced doctor to perform your surgery and to be very involved in your care. Ohio’s teaching hospitals are important to train the doctors of the future, but your health and well-being should not suffer because you are being used as the guinea pig for a brand new doctor.

 

Craig McLaughlin represents people who have been seriously injured or killed as a result of nursing home neglect, motor vehicle crashes, defective products, workplace accidents and medical negligence. He has been recognized by Super Lawyers, Martindale-Hubbell, AVVO and is a life member of the Multi-Million Dollar Advocates Forum and Million Dollar Advocates Forum.

5 tips from an Ohio nursing home neglect lawyer for choosing a good nursing home for a family member

By Craig McLaughlin

In 2010, the United States Census Bureau recorded the greatest number of people age 65 and older in census history.  The number was 40.3 million people, or 13% of the population, and that number is only going to go up into the future.  As people live longer, many Ohioans are going to need medical care and assistance that can only be found at a nursing home.  There are almost 1,000 nursing homes in Ohio. So how can you find out what is a good nursing home vs. a bad one? Here are 5 quick tips to help you select a nursing home for your family member.

1. Check out the nursing home on the Ohio Department of Health and Medicare websites

choosing the right nursing home
Photo: Ulrich Joho/CC BY 2.0

The Ohio Department of Health (ODH) is responsible for monitoring and regulating nursing homes in Ohio.  These facilities are subject to regular inspections by investigators from the ODH.  The ODH puts out the Long-Term Care Consumer Guide which contains inspection reports, facility details, family satisfaction survey scores, and resident satisfaction survey scores.

Many Ohio nursing home residents pay for their care by using Medicare and Medicaid.  In order for a nursing home to receive payment from the government, it must comply with minimum standards that are established.  The Federal Centers for Medicare and Medicaid Services monitors and compares these facilities to see which ones are doing a good job. Their website, Nursing Home Compare, contains quality of care information on more than 15,000 nursing homes.

2. Visit the nursing home to see how the staff interacts with each other

I recommend that you actually go and visit the nursing home and spend an hour or two in the waiting area or other common areas of the facility and just observe what happens in a typical day.  Pay attention to how the nurses, therapists, and aides interact with each other.  Chances are if they are being rude to each other, then they are going to be rude to your family member, especially when you’re not there.  Also, watch to see if they are taking the time to talk to the residents or are too busy gossiping with each other and are ignoring the residents.

3. Ask questions of the nurses and nurse’s aides

In the past, many of the owners of Ohio nursing homes lived in the same community and knew many of the residents before they even started living at the nursing home.  They treated the residents like family.  This has changed as more and more nursing homes are bought up by large national corporations who are more concerned with cutting costs in order to improve their stock price.  With Medicare reimbursement and Medicaid reimbursement rates remaining flat and expenses going up, this often results in staffing of the nursing homes being kept to the bare legal minimum. This means nurses and aides are often overworked and underpaid.

I encourage you to ask actual nurses and nurse’s aides at the nursing home how long they have been at that particular facility.  If the nurses and aides have been there a long time, then that is a good sign the employees are being compensated fairly, are not being stretched too thin, and will likely provide better care to your family member.  Also, ask them if they work a lot of overtime or double shifts. If the answer is yes, then that can be a bad sign that patient care is going to be negatively affected by short staffing.  Please remember you need to get past the marketing person who is giving you a fancy brochure and a tour of the facility and ask questions of the actual care providers.

4. Give the nursing home the smell test

It’s a sad fact aging can lead to the loss of bowel and bladder control.  A person’s medication can also cause gas.  These things can lead to some unpleasant, but not unexpected smells, at a nursing home.  However, if the facility smells like stale urine, then that can be a sign the nursing home is not being cleaned routinely or correctly.

5. Give the nursing home the taste test

Ask the nursing home if you can eat a meal in the dining area. Where the residents eat, how the food looks, and how it tastes is also a good indicator of the quality of care your family member will receive at the nursing home. If a lot of the residents eat their meals in their rooms instead of the dining area, then that can be a sign that they are not receiving a lot of attention from the staff.  Is the food visually appealing? Is it edible? Food is often very important not only for good physical health, but also can improve the spirits of your family member.

With the baby boomer generation getting older and people living longer, it should be no surprise that new nursing homes are being built in Ohio.  But how do you know if these new facilities or existing nursing homes are any good? If you are faced with the difficult decision of putting your loved one into a nursing home or some type of assisted living facility, then I encourage you to follow these five tips in order to select a safe place for your family member.

 

Craig McLaughlin represents people who have been seriously injured or killed as a result of nursing home neglect, motor vehicle crashes, defective products, workplace accidents, and medical negligence. He has been recognized by Super Lawyers, Martindale-Hubbell, AVVO, and is a life member of the Multi-Million Dollar Advocates Forum and Million Dollar Advocates Forum.