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Essure Birth Control Problems Heard by FDA

/ Defective Products /

NEW YORK – Severe headaches, heavy bleeding and countless other complications could be the result of what was once marketed as a ‘safe’ implant. Thousands of women are now questioning the safety of the popular birth control device “Essure” after many of them have reported severe side effects. ABC News reports some of these women were in Washington, demanding the U.S. Food and Drug Administration (FDA) to pull the product off the market.

“These side effects are real and our experiences are real,” Amanda Holt told the team of FDA panelists.

Patients like Holt have reported a long list of potential side effects ranging in scope and severity. Many women claim the device failed and resulted in pregnancy and in some cases the device may be linked to stillbirths. The device, which is inserted into the fallopian tubes, was placed on the market in 2002 but the device manufacturer didn’t change its warnings until 2014.

Defective product attorneys at Cellino & Barnes are now evaluating Essure cases – and those injured could be entitled to significant compensation.

“This device has been documented to cause severe injuries included but not limited to device migration, perforations and debilitating side effects,” dangerous drug attorney Mike Williams said. “Some women had pain so severe they required doctors to surgically remove the device, which was supposed to be a permanently emplaced contraceptive implant.”

Other birth control devices such as the Merina IUD require removal after five years. Other implants like hip devices can be under warranty for a decade and patients should expect future surgeries. However, Essure is marketed as a permanent implant and it’s not specifically designed to be the surgically removed.

Doctors report some women have even died as a result of complications from the surgery or the device itself.

The FDA panel will recommend more research about allergic reactions and side effects caused by Essure, according to ABC News. The panel will also suggest adjustments to the label and more training for doctors who are implanting or removing the implant.

On its website, the FDA acknowledges receiving a large number of reports and complaints related to Essure, including at least 11 deaths:

From Nov. 4, 2002, Essure’s approval date, through May 31, 2015, the FDA received 5093 medical device reports related to Essure. The majority of reports received since 2013 have been voluntary reports, mostly from women who received Essure implants.

The most frequently reported patient problems during this period were pain/abdominal pain (3353), heavier menses/menstrual irregularities (1408), headache (1383), fatigue (966), and weight fluctuations (936). Most of the reports received listed multiple patient problems in each report. The most frequent device problems reported were patient device incompatibility (941) (for example, possible nickel allergy), migration of the device or device component (482), device operating differently than expected (301), device breakage (259), and malposition of the device (133). Multiple device problems can also be listed in each report.

Seventeen of the reports received were coded as death reports. Six of these reports were mistakenly coded as death, but no death occurred. Five reports involve fetal deaths that occurred in women who became pregnant following placement of Essure. The remaining six death reports were related to a total of 4 adult deaths: one death due to Group A Strep infection post-procedure, one death reportedly due to uterine perforation during device placement, one death related to an air embolism during device removal surgery and one death from suicide.  Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report.

“These are life-altering side effects that stop you from functioning as a person,” Angie Firmalino said in a statement to the FDA.

The FDA reports it has received over 20,000 complaints regarding the product manufactured by Bayer, which defends Essure and continues to market the product to women as an alternate and permanent method of birth control.

If you believe you or a family member has suffered adverse health effects while using this implant, contact an attorney at Cellino & Barnes online today or call 800-888-8888 for a free case evaluation.


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Feds Investigate Popular Birth Control Implant

/ Defective Products /

Feds Investigate Popular Birth Control ImplantNEW YORK – If you’re harmed because of a defective product or a dangerous drug, you deserve answers and in some cases, significant compensation. After hearing thousands of complaints, investigators with the U.S. Food and Drug Administration will search for answers to questions regarding a popular birth control device called Essure, according to ABC News.

The implant, a small metal spring designed to ‘catch’ eggs, was approved by the FDA in 2002 but recently, federal investigators have received over 20,000 complaints from women via Facebook and Twitter.

The manufacturers of the birth control product have acknowledged side effects such as pelvic pain, according to the FDA but New York defective product attorneys say some of the complaints have been more serious.

“In some cases, not only has this product failed to prevent pregnancies, it’s also been linked to severe pain and it could be deadly for women in New York,” defective product attorney Steve Barnes said. “We’re hoping to raise awareness about these side effects and help the women who have suffered because of this device.”

Barnes, a partner at the Law Offices of Cellino & Barnes, said defective products are one of the most common causes of injury and death in America today. According to the FDA, several women have complained about memory loss and hallucinations as the result of the Essure implant. In some cases, these women required hysterectomies to remove the device.

Essure is now the subject of a petition, urging the FDA to issue a recall.

“Over the past several years, the Agency met with patients and patient advocates to better understand patient issues and experiences after Essure placement,” the FDA said in a statement. “We will continue to work with these individuals as we continue our efforts to better understand their experiences with this device.”

Some doctors have reported performing hundreds of operations to remove the device to prevent further pain and suffering. Some of the side effect injuries include severe back pain, unexplainable fatigue, depression, bleeding, headaches, organ perforation, and side effects as the result of nickel allergies.

New York defective product attorneys at Cellino & Barnes are investigating this product and the complications associated with it. If you’ve been injured or suffered severe effects as the result of using Essure or another birth control device, contact the lawyers at Cellino & Barnes to learn more about your legal rights for free.

Medical Device to Stop Blood Clots Linked to 27 Deaths

/ Defective Products /

Medical Device to Stop Blood Clots

NEW YORK – Doctors and attorneys are warning patients of a risky medical device sometimes used to prevent blood clots. According to an NBC News investigation, some of these devices have been associated with further hospitalization, more risky procedures, and in at least 25 cases, death.

The device is called an IVC filter. These metal spider-like implants are placed in the main artery beneath the heart and lungs to protect them from clotting. The filter is meant to act as a trap for clots but it has been document to break apart, releasing small, sharp metal objects into the blood stream.

Investigative journalists with NBC News discovered after the problems with the device began surfacing, one manufacturer hired public-relations giant Hill and Knowlton. The PR firm then developed a crisis management plan, warning that “unfavorable press” could damage stock prices and ruin reputations. The company also retained an outside doctor to conduct a confidential study, which was obtained by NBC News.

The doctor found the IVC filter had higher rates of relative risk for death, filter fracture and movement than all its competitors.

“Further investigation…is urgently warranted,” the doctor wrote in his report.

New York defective product attorneys at Cellino and Barnes say the device has been known to cause further medical treatments but the product remains on the market.

“There could be hundreds or thousands of people with this implant in New York,” defective product attorney Ross Cellino said. “Parts of the metal filter can tear off and pierce vital organs like the heart or lungs.”

Around 250,000 IVC filters are used every year and the U.S. Food and Drug Administration has warned the public of these devices since 2010 but the agency has not removed them from the market.

So far, 27 deaths and 300 other injuries have been associated with one brand of IVC filter alone. With more than 10 different manufacturers putting this product on the market, attorneys say thousands of others face the risk of injury.

“Some patients have described the pain as like a knife being pushed into your stomach,” Cellino said. “In some cases, patients lost consciousness and required immediate surgery to save their lives.”

A company that manufactures IVC filters told NBC News in a statement, “While we can’t speak to the specific details of individual patient experiences, when used as instructed… IVC filters have a safety profile consistent with [published medical guidelines].”

Due to the product’s high risk and dozens of complaints, the FDA now recommends only temporarily using IVC filters to protect against blood clots. The FDA said the device should only be used if medications and other treatments were not effective.

If you believe you’ve been injured by an IVC filter or have any questions regarding the risks associated with these devices, New York defective product attorneys at Cellino & Barnes recommend contacting a lawyer for a free evaluation.

Defective Products and the Painful, Permanent Injuries

/ Defective Products /

Defective Products and the Painful, Permanent InjuriesROCHESTER, N.Y. – Hundreds of defective products can lead to thousands of injuries each year. Federal courts are currently reviewing tens of thousands of injury claims, each blaming a defective product for harm or complications. One such product is transvaginal mesh.

The product is a net-like implant used to keep internal organs from slipping forward or down. However, the product’s design and implantation techniques may lead to serious and painful complications to internal organs.

Rochester defective product attorneys at Cellino & Barnes say, in many cases, the victims weren’t warned about the possible complications.

“Some of these manufacturers may have known that their mesh was causing serious side-effects that negatively impacted the lives of many women in Rochester,” defective product attorney Ross Cellino said. “Some of these injuries are permanent and some women will need surgery to minimize the damage.”

Currently, there are more than 28,000 cases pending against Ethicon, a subsidiary of Johnson & Johnson. Each of these cases blame the company’s pelvic repair systems for serious, ongoing and painful injuries suffered by thousands of women.

Due to the ongoing pain and, in some cases, disability, many cases cite a ‘profound loss of quality of life.’ Ethicon’s vaginal mesh is not the only product facing scrutiny at the federal level. A number of manufacturers face pending litigation.

In 2011, the U.S. Food and Drug Administration (FDA) issued a warning to consumers, informing women of the possible complications, which the FDA said ‘were not rare.’

Last year, the FDA issued proposals to address the risks associated with surgical mesh. The proposals would require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh.

Hundreds lawsuits have been filed against manufacturers since the FDA’s warning. Nearly every case claims the companies failed to tell women about the potential complications they could have and the seriousness of their injuries.

Dangerous Household Products to Take Note Of

/ Defective Products /

Dangerous Household ProductsBUFFALO, N.Y. – Every time a person steps outside their home, they take a risk. Every day, thousands of car accidents send people to the hospital, construction accidents and workplace injuries are not uncommon either. However, many people don’t realize thousands of accidents actually occur inside their own homes.

Nationwide Children’s Hospital in Columbus, Ohio estimates an average of 36,000 bunk bed-related injuries happen in America every year. Thousands of other household products can result in life-threatening injuries as well.

Buffalo defective product attorneys at Cellino & Barnes say products are constantly changing and their dangers may not always be obvious or even labeled.

“There’s a reason many boxes warn parents of a choking hazard when you’re shopping at a toy store in Buffalo,” defective product attorney Steve Barnes said. “Not every toy or product will warn you about its potential risks and hazards, and that can be dangerous.”

Medications and facial cleansers typically stored in a bathroom can be poisonous to children. More than 10,000 cases of poisoning are reported every year due to chemicals known as ‘hydrocarbons’ found in certain bath oils.

Even heavy furniture has been known to send individuals to the emergency room. Nearly 15,000 kids have been admitted to hospitals following furniture tip-overs, such as a large big-screen TV or an armoire.

Studies have found that 9,400 children are treated every year following accidents in high chairs, likely from the high chair falling over, leaving a child’s head exposed to a potentially fatal impact with the ground.

“The Consumer Product Safety Commission is constantly updating its standards and recalling products that can be considered dangerous,” Barnes said. “Still, some accidents go unnoticed or unreported, which is why it’s important to at least contact an attorney and evaluate the potential of your case. In the end, it may prevent another injury.”

The Consumer Product Safety Commission reported 16 incidents of unintentional strangulation, many of which involve bed posts and bunk beds. Nearly every case was fatal.

Keep watching cellinoandbarnes.com/blog for the latest common household recalls.

 

Feds Investigating Hysterectomy Device as Cause of Cancer

/ Defective Products /

Feds Investigating HysterectomyNEW YORK – Federal agents have launched an investigation into a surgical device known to spread cancer in women, according to The Wall Street Journal. The Journal reports the FBI is looking into the makers of laparoscopic power morcellators, used in hysterectomies.

The largest manufacturer of the surgical device is Johnson & Johnson and the FBI may want to know if company execs knew about the tool’s risks before it was pulled from the market last year.

The FBI’s Newark, N.J. office is reportedly overseeing the investigation but an FBI spokesperson declined to confirm the inquiry by saying, “we don’t comment on the existence or nonexistence of any investigation.”

The Journal reports FBI agents have already interviewed a retired pathologist who alerted Johnson & Johnson about potential problems with morcellators in 2006; a doctor who went public after her own cancer was worsened by the tool in 2013; and a California woman who has collected names of close to 400 patients and families of patients who may have been harmed by the device.

The investigation comes nearly seven months after the U.S. Food and Drug Administration warned morcellators shouldn’t be used in most hysterectomy procedures.

 

5 Facts You Should Know About Massive Airbag Recall

/ Car Accident, Defective Products, Driver Safety /

Massive Airbag RecallBUFFALO, N.Y. – The 33.8 million vehicles recalled by Japan’s Takata Corporation is the largest recall in automotive history. The recall is also creating mass confusion among U.S. consumers wondering if their vehicle is part of the recall or if their family is at risk of being victimized by defective air bags.

So many people were trying to log into the National Highway Traffic Safety Administration’s sister website, SaferCar.gov that the site crashed on occasion this week.

“These air bags were installed in more than 50 different vehicle models that could be driving around Buffalo,” car accident attorney Ross Cellino said. “These can pose serious safety hazards to anyone who drives or rides in these vehicles.”

Buffalo car accident attorneys say Takata’s recall was issued when it was discovered that some airbags may spray shrapnel when they inflate and the faulty safety devices have been liked to at least six deaths.

“There are several ways to find out if your car is part of this increasingly large recall and if you or a family member has been in a recent accident, it’s important to know if that vehicle was part of this recall as well,” Cellino said.

-FINDING IF YOUR VEHICLE IS LISTED IN THIS RECALL:

The recalls are posted at SaferCar.gov, in which you type in a Vehicle Identification Number and the site will tell you if your vehicle is part of this specific recall, or others. NHTSA reported receiving over 600,000 requests this week, so consumers may need to be patient.

-ODDS ARE LOW:

Although there is a real danger of being injured by exploding airbags, the odds of suffering an injury associated with this recall is low. Of the 33.8 million vehicles recalled, six people have died worldwide and another 100 have suffered injuries. That equates to a .00031% chance of getting hurt.

-WHAT MODELS ARE INCLUDED?

The Takata airbag recalls began in 2008 when Honda recalled 4,000 Accords and Civics (2001 models). The recalls have obviously expanded, now to include almost every automaker, but it has taken seven years to do so. It is unclear exactly how many models will be included in the company’s final recall, or when that may occur.

-KEEP REPAIR TIME IN MIND

One in seven vehicles are part of this massive recall. Dealerships and auto shops charged with fixing these vehicles may be overwhelmed with the number of repairs and lengthy wait times should be expected but it is important to get your vehicle fixed as soon as possible to prevent serious injuries.

-HOW DO I PAY FOR THE REPAIR?

Buffalo car accident attorneys said in most recall situations, consumers do not pay for the repairs to their vehicles.

“If your vehicle is part of this recall, it’s important to know you shouldn’t pay a dime for someone else’s mistake,” Cellino said. “Recall repairs are free at dealerships, the question now is how much will the airbag manufacturer be ordered to pay?”

There may be other financial consequences as a result of this massive safety recall. For example, vehicle value may drop and there are questions of liability in case of an accident; does responsibility fall on Takata, the automaker, or both?

The latest recall could be just the beginning of an ongoing legal drama in U.S. courts.

 

At Least 80 Deaths Due to Delayed Auto Recall

/ Dangerous Products, Defective Products, Product Recall /

At Least 80 DeathsNEW YORK – A major U.S. carmaker is paying at least $1 million to victims of faulty ignition switches in several popular car models. General Motors Co. set up the $400 million compensation fund after dozens of people died because drivers would inadvertently shut off the engine and disable power steering and air bags.

Last year, the automaker recalled several models of Chevrolet Cobalts, Saturn Ions and other vehicles with ignition switch issues and paid a then record-setting $35 million fine to the National Highway Traffic Safety Administration (NHTSA). The administration claims GM knew about the faulty ignition switches but delayed issuing a recall for years.

“So far, over 4,000 claims have been submitted against the automaker,” auto recall attorney Ross Cellino said. “Hundreds of those are death claims.”

The compensation fund noted 80 death claims have been approved. Every claim was linked to the company’s delayed recall of 2.6 million cars.

“It’s important for all automakers to take responsibility for their mistakes and own up to it as quickly as possible,” Cellino said. “Many of those lives could have been saved; these are people who didn’t have to get hurt.”

For those who believe they’ve been hurt in a recalled vehicle, auto recall lawyers suggest going over your case with an attorney before filing a claim with the car company. According to the compensation fund, if a person or a victim’s family accepts an award, they cannot file a lawsuit against the automaker.

The Detroit News reports fund administrators have, so far, made 126 offers to victims found eligible.

Report: Mesothelioma a “Global” epidemic

/ Defective Products /

Mesothelioma a "Global" epidemicNEW YORK – A pair of Italian researchers say mesothelioma has achieved ‘epidemic’ status in many places and it’s not slowing down.

Claudio and Tommaso Bianchi of the Center for the Study of Environmental Cancer issued a new report detailed in the Indian Journal of Occupational and Environmental Medicine. Their report crunched numbers from cancer registries around the world and found there was an alarming upward trend of mesothelioma cases.

Although the Bianchis found more and more cases are being reported around the globe, the researchers also said that in many countries, mesothelioma data wasn’t even available.

The deadly disease is most often linked to asbestos exposure. According to the Bianchis’ study, the countries with the highest rates of mesothelioma are also countries where asbestos was generally accepted and heavily used as a building additive after World War II.

The Bianchis’ study suggests mesothelioma cases are not only increasing around the world but many countries continue to ignore the risks.

“The lack of data for a large majority of the world does not allow that the consciousness of the risks related to asbestos exposure is reached,” they concluded in their report.

According to U.S. researchers, nearly 2,500 Americans are diagnosed with the cancer every year.

Report: gas tanks still exploding 18 months into recall

/ Auto Accident Information, Car Accident, Dangerous Products, Defective Products, Driver Safety /

Report: gas tanks still explodingDETROIT – Jeep vehicles continue to be linked to deadly collisions more than 18 months after Chrysler issued a recall.

Many Jeep Liberty and Grand Cherokee vehicles were recalled when it was found the gas tanks can explode during rear-end collisions. According to Bloomberg, more than 1 million of these models have not been repaired yet and at least six people have died in highway crashes since the June 2013 recall.

The original recall includes 2002-07 Jeep Liberty and 1993-98 Jeep Grand Cherokee SUVs.

National Highway Traffic Safety Administration (NHTSA) Deputy Director David Friedman said in November that only 3 percent of the 1.56 million affected vehicles were repaired in a six-month period. Bloomberg puts that repair rate as the lowest for any recall of more than 1 million vehicles in the last five years.

Bloomberg estimates a total of 62 people have died from injuries related to Jeep’s exploding gas tanks.

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