UPDATE: Potential Risks with Liquid-filled Intragastric Balloons – FDA Letter to Health Care Providers

Angel Reyes III In The News, Medical Devices

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UPDATE: The FDA continues to work with the manufacturers to evaluate reports of deaths in patients with liquid-filled intragastric balloon systems used to treat obesity. Since the August 2017 update:

  • The FDA has received reports of five additional deaths that occurred worldwide since 2016. Four of these deaths (three with the Orbera Intragastric Balloon System manufactured by Apollo Endosurgery, and one with the ReShape Integrated Dual Balloon System manufactured by ReShape Lifesciences) occurred following gastric perforation one  day to 3.5 weeks after balloon placement. The fifth death was reported for a patient who had the Orbera Intragastric Balloon System.  The report does not mention a perforation event and the manufacturer is still investigating this death.

Since 2016, the FDA has received reports of a total of 12 deaths that occurred in patients with liquid-filled intragastric balloon systems worldwide. Seven of these 12 deaths were patients in the U.S. (four with the Orbera Intragastric Balloon System, and three with the ReShape Integrated Dual Balloon System).

In collaboration with the manufacturers, the FDA has approved new U.S. labeling for the Orbera and ReShape balloon systems with more information about possible death associated with the use of these devices in the U.S. Please see the statements from each manufacturer (Apollo Endosurgery and ReShape Lifesciences) for additional details about the new labeling.

The FDA recommends health care providers:

  • Instruct patients regarding symptoms of potentially life-threatening complications such as balloon deflation, gastrointestinal obstruction, ulceration, and gastric and esophageal perforation
  • Monitor patients closely during the entire term of treatment with liquid-filled intragastric balloon systems for potential complications, including acute pancreatitis and spontaneous hyperinflation as stated in our February 2017 letter to health care providers
  • Report any adverse events related to intragastric balloon systems through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA will continue to monitor the safety and effectiveness of these approved devices by working with the manufacturers to monitor death reports, assess possible risk factors and mitigations, and ensure that the products’ labeling address these risks. The FDA will keep the public informed as significant new information or recommendations become available.

On August 10, 2017, the FDA issued an update “to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity.” The update states:

Four reports involve the Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and one report involves the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc. All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement.

The FDA update also alerts the FDA has received “two additional reports of deaths in the same time period related to potential complications associated with balloon treatment, one gastric perforation with the Orbera Intragastric Balloon System and one esophageal perforation with the Reshape Integrated Dual Balloon System.

On February 9, 2017, after receiving “several dozen adverse event reports regarding balloon over-inflation of liquid-filled systems” and a separate set of reports indicating that “acute pancreatitis developed in several patients,” the FDA issued a letter to health care providers which recommended that health care providers closely monitor patients with liquid-filled intragastric balloon systems for two types of adverse events:

(1) spontaneous hyperinflation (the liquid-filled intragrastric balloon over-inflating with air or more liquid in patient’s stomachs) or

(2) development of acute pancreatitis. The FDA reported that both adverse events resulted in the need for premature device removal.   See February 9, 2017 FDA letter.

According to the FDA, as of February 9, 2017, labeling for liquid-filled intragrastric balloons did not address the issues of spontaneous over-inflation or acute pancreatitis. Since the issuance of the February 2017 letter, both manufacturers have revised their product labeling to address these risks.

See August 10, 2017 FDA Update.

The FDA has reported that the symptoms of balloon over-inflation include “intense abdominal pain, swelling of the abdomen (abdominal distension), with or without discomfort, difficulty breathing, and/or vomiting” while symptoms of acute pancreatitis include “severe abdominal and back pain.” See February 9, 2017 FDA letter.

The experienced team of trial lawyers at the Reyes Browne Reilley Law Firm focus on the representation of plaintiffs with personal injury claims and survivors with wrongful death claims. Reyes Browne Reilley is currently accepting cases in all 50 states for individuals who had a liquid-filled intragastric balloon system and experienced the injuries or death described above. Please contact our experienced attorneys immediately for a free case consultation – you may fill out the form to the right or call us toll-free 24 hours a day at (877) 977-2286.

Can Your Hip Replacement Kill You?

Angel Reyes III Defects, Medical Devices

Hip-Death-1024x768When Dr. Stephen Tower’s right hip gave out in 2006, he asked his surgeon to implant an artificial one — specifically, a metal-on-metal hip called the ASR XL, made by Johnson & Johnson. He knew what he was asking for, but what he knew wasn’t enough to protect him from a defect in the device.

Five years after his surgery, and in excruciating pain, Dr. Tower underwent more surgery, this time to have the device replaced. When the surgeon sliced into his hip, what he saw looked like a crankcase full of dirty oil. Tissue surrounding the hip was black. Cobalt leaking from the ASR hip had caused a condition called metallosis, destroying not only local muscle, tendons and ligaments, but harming Dr. Tower’s heart and brain as well.

Johnson & Johnson withdrew the ASR XL model from the market in 2010, but continued to sell another similarly problematic model, the Pinnacle, until 2013.

More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers. These suits and others are pulling back the curtain on what some doctors call the Wild West of medicine: the untested and largely unregulated medical device industry.

About 32 million Americans, or about one in 10, have at least one medical device implanted – from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.

Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.

Many people assume that the Food and Drug Administration requires rigorous testing of medical devices before they are approved. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.

Since medical devices didn’t come under regulatory control by the F.D.A. until 1976, the agency simply grandfathered in all devices that were already on the market under a provision known as 510(k), which allows manufacturers to sell most new devices without requiring any clinical testing as long as the manufacturer says its product is “substantially equivalent” to an existing device.

With such shockingly lax regulations, it’s no surprise that device recalls have risen over the years; in 2003, there were eight Class 1 device recalls, which the F.D.A. defines as indicating “a reasonable probability” that a device will “cause serious adverse health consequences or death.” In 2016, that number rose to 117, affecting hundreds of thousands of patients.

FDA Again Strengthens Requirements For Mesh

Angel Reyes III In The News, Medical Devices

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Mesh warnings from the U.S. Food and Drug Administration (FDA) are nothing new, but last week the FDA announced that surgical mesh to treat pelvic organ prolapse (POP) will be reclassified as a Class III (or high risk) medical device. Part of the FDA press release also indicated that manufacturers will need to receive premarket approval (PMA) for their safety and effectiveness in order to keep selling their product.

Back in 2002, surgical mesh was cleared by the FDA as a Class II (or moderate risk) treatment for reinforcing pelvic floor muscles and permanently repairing pelvic organ prolapse. In the 10 years which followed, the agency received thousands of reports about adverse events connected to mesh products.

The FDA first cautioned patients about mesh in 2008. That year, the federal agency reported more than 1,000 mesh adverse reports for (among others) pelvic pain, infection, bleeding, organ perforation, urinary problems (to put it lightly), and vaginal scarring. In 2011, the FDA issued a second warning. They had received nearly 2,000 more adverse reports, and only went do far as to say the events were ‘not rare’. Providers and patients were warned to ‘be aware of the risks’ before pursuring mesh-related treatments.

After those relatively light warnings, it’s no wonder POP-related surgeries using mesh went up between 2008 and 2011. One study found a nearly 45% increase in New York from 2008 to 2011. POP-related surgeries are big business. In the United States alone, there are over 300,000 such surgeries annually.

Only now that there are tens of thousands pending mesh-related lawsuits, and even more advserse events stacking up, the FDA is finally getting serious regarding mesh usage. Unless the five manufacturers currently making transvaginal mesh can document its safety, it’s entirely likely the product will will be gone by the end of this decade.

Data indicates POP repair with surgical mesh is no more effective than POP repair with sutures alone. It’s doubtful anyone will miss mesh at that point. Except for the manufactures who made billions of dollars from mesh.

FDA News Release

The Daily Beast – Transvaginal Mesh Is the Stuff of Nightmares

Jury Awards Over $12 Million in Johnson & Johnson Mesh Trial

Angel Reyes III Defects, In The News, Medical Devices, Products

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Yesterday, a Philadelphia jury ruled Johnson & Johnson (J&J) must pay an injured woman $5.5 million in compensatory damages for its negligence over the defectively designed Prolift pelvic mesh. Today, the jury also awarded her $7 million in punitive damages – a sum intended to punish Johnson & Johnson for having marketed an unsafe product.

This was the second product liability trial involving Prolift mesh, one of the most widely used pelvic meshes produced. The first Prolift trial of Linda Gross in 2013 resulted in a $11.1 million ruling for Ms. Gross but did not find the mesh was defective in its design. That verdict is still under appeal.

In the two-week Philadelphia trial of Patricia Hammons (64) of Indiana, the jury found for the plaintiff on all claims; defective design, a failure to warn doctors about its dangers, negligence in manufacturing, and in bringing Prolift to market.

Attorneys for Ms. Hammons were Shanin Specter of the law firm Kline & Specter and Adam Slater of the law firm Mazie Slater. Plaintiff attorney Adam Slater says he is not settling his clients, and intends to take their cases to verdict. ”J & J has displayed an attitude so far that they don’t care what the jury says, they don’t care what the judge says, they’re bigger than everyone else. They do things on J&J’s terms. That’s my impression of them.” said Slater.

Attorney Shanin Specter (Kline & Specter) said the Prolift pelvic mesh implant has too much mesh which causes scar tissue, mesh contraction and erosion. “The amount of mesh could stretch across two-and-a half football fields”, he told jurors. Ms. Hammons suffers mesh erosion into her bladder and excruciating pain during sex or dyspareunia. The mesh was found to have folded under her bladder and repeated surgeries have caused a shortened vagina.

The defense team blamed pain during sex on the plaintiff’s hysterectomy she underwent in 2009 and additional prolapsing of her small bowel and uterus. “Prolift had nothing to do with the fact she later developed the bowel prolapse”, said Specter.

Ethicon removed Prolift from the market three years ago after the U.S Food and Drug Administration required it to do three year post-approval monitoring for its effects on women. If you or a loved one has suffered due to transvaginal mesh related injuries, contact the legal team at Reyes Browne Reilley Law Firm to confidentially discuss your legal rights and mesh removal options.

Sources:

Mesh Medical Device News Desk

Philly.com

Hundreds of Endo Transvaginal Mesh Lawsuits Being Settled

Angel Reyes III In The News, Medical Devices

More than 100 plaintiffs have reached a settlement with American Medical Systems Inc, a subsidiary of Endo International PLC which has agreed to pay $830 million as a result of personal injury lawsuits stemming from the health complications allegedly caused by trans-vaginal mesh devices. The company is presently trying to resolve approximately 20,000 ongoing lawsuits that claim the trans-vaginal mesh devices have caused chronic pain, incontinence and other problems such as surgical complications when attempting to remove them. Vaginal mesh devices are a treatment recommended by doctors to thousands of women who were implanted with theses defective devices after suffering from conditions known as “pelvic organ prolapse” and “stress urinary incontinence” which are caused by child birth, hysterectomy and menopause.

Many drug companies and medical manufacturers such as Endo International PLC subsidiary American Medical Systems Inc., thought they had come up with a solution to the above medical conditions with their trans-vaginal mesh products marketed under names like Apogee and Perigee as well as other names. The term trans-vaginal comes from the way the device is inserted into the women. A doctor inserts a trans-vaginal mesh into a women’s vagina rather than having to use surgery which is more invasive and risky. These products it has been claimed do more harm to women than good and manufacturers, marketers and others are being sued by thousands of women for damages and pain and suffering caused by trans-vaginal mesh products. And the plaintiffs are winning.

In May 2015, a women was awarded $25 million for pain and suffering and $75 million in punitive damages as a result of having used the trans-vaginal mesh devices made by Boston Scientific and Ethicon. The device caused the women to have to undergo several revision surgeries.

Johnson & Johnson was forced to pay a women $5.7 million after several surgeries failed to remove her trans-vaginal mesh device that had grown into the surrounding tissue.

These are just a few of the hundreds of successful lawsuits being brought in 2014 and 2015 regarding fraud and negligence on the part of manufacturers, marketers and doctors involved in selling, implanting, and removing trans-vaginal mesh devices for women. If you or a loved one has suffered complications associated with one of these devices, please give our experienced DFW product liability lawyers a call for a free consultation. You will speak with one of our experienced and knowledgeable DFW medical malpractice attorneys about your experience with the trans-vaginal mesh device.

Defective CareFusion 203 EnVe and ReVel Respiratory Ventilators Recalled

Angel Reyes III Defects, Medical Devices, Personal Injury, Uncategorized

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The U.S. Food and Drug Administration (FDA) announced a class I recall of over 100 lot numbers of CareFusion 203 ventilators after a power connection failure was observed in over 250 incidents. Reports list EnVe and ReVel models losing power and shutting off caused by a misalignment of pins where the external power connector meets the input port of the ventilator.

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Breaking News: Boston Scientific Transvaginal Mesh Verdict

Angel Reyes III In The News, Medical Devices

scales-of-justice-balance-transvaginal-mesh-case-300x300A Dallas jury has awarded in excess of $73 million to Martha Salazar for her transvaginal mesh implant lawsuit against Boston Scientific. The Dallas jury heard testimonies from Martha Salazar and representatives for Boston Scientific before reaching their decision in favor of Salazar.

Salazar alleged that her operation, which took place on January 17, 2011, was performed by Dr. Jorge Lopez to solve incontinence and instead caused worse medical problems. Medical problems caused by Salazar’s implant include dyspareunia, pain and irreversible nerve damage to femoral and obturator nerve. Some damage caused her to walk with a limp, has gone through numerous surgeries to repair the damage and faces many more.

Among Salazar’s claims are that she was inadequately warned of the dangers of the procedure, as well as belief that Boston Scientific did not properly test the product used in her surgery on humans. She claimed that Boston Scientific withheld information regarding clinical trials, including the lack of study regarding the obturator approach during implant.

The verdict reached by Salazar’s case proves that when medical companies try to take advantage of patients, they will be met with a strict verdict. If you are considering a lawsuit regarding transvaginal mesh surgery or placement, the experienced dangerous device lawyers at Reyes Browne Reilley can help you get the right outcome to your case.

Enhancement Medical Recalls Expression Gel for Undocumented Concentration

Angel Reyes III Dangerous Drugs, Medical Devices

08192014The Food and Drug Administration (FDA) has announced a recall of all units of Expression 1.5cc gel used in intranasal splint procedures. The gel, manufactured by Enhancement Medical, may have been manufactured without proper monitoring of the concentration of hyaluronic acid. Improper concentrations of active ingredients can cause adverse reactions in patients.

An initial recall of certain lots of Expression gel was issued in August 2013 after Enhancement Medical received 68 complaints of patients experiencing the following adverse effects after use.

  • swelling.
  • lumps.
  • firmness.
  • pain.
  • bruising.
  • redness.
  • itching.
  • discoloration.
  • and, development of hard nodules.

 

Enhancement Medical’s analyses of the recalled lots found that the adverse reactions were due to a hyper-concentration of hyaluronic acid. Further investigation led Enhancement Medical to recall all units since the original manufacture date of August 15, 2012 after the company was unable to confirm that the final concentration of all units of Expression gel contained the correct concentration of hyaluronic acid.

The FDA is also tracking cases where Expression gel was used as a dermal filler to fill facial wrinkles, a use for which the gel is not approved. Health care providers have been alerted to discontinue use of Expression gel for any reason and return any unused product to the manufacturer.

Medical device and drug recalls typically take place only after the FDA has received complaints of adverse reactions. It is important for patients and medical professionals to report unusual or severe side effects as soon as possible to help the FDA and manufacturers determine whether or not the product is defective or dangerous.

Vascular Solutions Recalls Some Langston V2 Dual Lumen Catheters Due to Defect

Angel Reyes III Defects, Medical Devices

07092014On May 23, the Vascular Solutions company issued a voluntary nationwide recall of 40 lots of their Langston® V2 Dual Lumen Catheters. The company received two reports of incidents where the inner catheter separated from the hub during use, potentially entering the patient’s circulatory system. But in each report, the catheter was retrieved without injury.

The lots recalled were manufactured between January 2014 and April 2014 and included model numbers 5540 and 5550. Vascular Solutions estimates that a total of 8,580 of the recalled catheters were sold between March to May 2014 and approximately 3,847 were unused in the field as of July 3.

The recall includes the following lot numbers:

  • 569436-569437
  • 569962-569965
  • 570177-570178
  • 570337-570341
  • 570504-570507
  • 570592-570593
  • 570674-570675
  • 570744-570746
  • 570836
  • 570926-570929
  • 571099-571103
  • 571350
  • 571412-571415
  • 571727

Hospitals that received the catheters have been asked to cease use and return unused products to Vascular Solutions for replacement. At this time, 86 percent of the defective catheters have been accounted for and are in the process of being returned.

Although the company initiated the recall in May, the press release from Vascular Solutions did not go public until July 3, and the information was not published to the FDA medical device recall page until July 7. With an estimated 14 percent of the defective medical devices still potentially in use, there is still a chance of patient injury from these catheters.

As a patient you cannot guarantee the safety of the medical equipment your doctor uses. However, you can help reduce your risk of adverse reactions to medications and equipment by informing your doctor of any allergies or past complications with medical care. Remember, if anything seems unusual about the equipment used in your care, alert a staff member immediately.

Image courtesy Vascular Solutions

Surgical Navigation Application Defect Highlights Software Recalls

Angel Reyes III Medical Devices

spine-CT-scanThe Brainlab, Spine & Trauma 3D 2.0 Navigation Software manufactured by Brainlab AG is being recalled due to faults with programming.

Recalls of defective products have taken place for well over a century, but most involve physical products. This latest revelation is part of a new generation of recalls – those affecting software.

The Brainlab AG application allows healthcare workers to create 3D maps of the inside of a human body, reducing the need for surgical examinations. During surgeries, the software allows doctors to precisely monitor the position and orientation of instruments, making operations less invasive, improving patient recovery time.

The FDA has released a list of guidelines operators should adhere to until an updated version of the software is available. Nationwide, there are more than 130 locations using the medical device application.

Brainlab is not alone in producing products with faulty software. In February, Toyota was forced to issue a recall on all new Prius automobiles. A total of 1.9 million vehicles had been manufactured with a glitch in programming that occasionally caused motors to shutdown, going into failsafe mode. Prius owners were asked to return their car to a dealer for a software update that took about 40 minutes to complete.

Nissan has its own challenges lately, issuing a recall of almost a million vehicles due to a defect in software controlling airbags.

Mazda recalled Mazda 6 cars manufactured between 2010 and 2012, because the vehicles attracted spiders. Their solution was a software update, warning drivers of arachnids in the engine.