Provigil (modafinil) and Nuvigil (armodafinil) are both medications prescribed widely as treatments for extreme sleepiness or other sleeping disorders, which help patients stay awake during normal waking hours. It is believed that both drugs work by enhancing dopamine signals within the brain. However, the stark truth is that the actual wakefulness mechanism of either drug remains unknown. The more common side effects of Provigil and Nuvigil are documented and well established. However, recently, these drugs have been scrutinized further for potential associations with cardiac issues, birth defects, and Stevens-Johnson Syndrome. Both modafinil and armodafinil are listed as schedule IV controlled substances.
Documented Side Effects from Clinical Trials
Originally developed in the 1970s by a French professor in medical sciences, Michel Jouvet, modafinil began as an experimental treatment for narcolepsy in 1986. It wasn’t until 1998 that American drug manufacturer Cephalon gained approval from the U.S. Food and Drug Administration (FDA) to market Provigil in the United States.
According to modafinil’s FDA labeling, the drug was evaluated for safety in over 1,100 patients in placebo-controlled clinical trials and the most common adverse reactions (those affecting 5% or more) were: headache, nausea, dizziness, and insomnia. Beyond the significance of these findings, the FDA’s label also lists the following as some other side effects witnessed during clinical trials at a rate of 1% or more:
Anxiety
Diarrhea
Dry Mouth
Depression
Dyspepsia
Fatigue
Palpitations
Rash
Upper Abdominal Pain
Agitation
Anorexia
Constipation
Contact Dermatitis
Increased Heart Rate
Migraines
Thirst
Tremors
Vomiting
Subsequent Warnings and More Serious Side Effects
Birth Defects and Use by Women
Both Provigil and Nuvigil are classified as “Category C” drugs by the FDA – a designation that the agency, while concerned about their use during pregnancy, does not have enough evidence to suggest a clear safety hazard. Nonetheless, according to some reports, the rate of congenital malformations in babies connected with exposure to modafinil and armodafinil is as high as 15%.
Teva Pharmaceuticals Ireland and Health Canada issued pregnancy and birth defect warnings in 2019 covering Provigil and Nuvigil. The warnings urge healthcare providers not to prescribe either medication to women who are pregnant or who plan to become pregnant. In 2009, the FDA was concerned enough to establish a “pregnancy registry” for Provigil and Nuvigil to gather more information on the possible association of the drugs with fetal development. The registry tracks pregnant women exposed to at least one dose of either medication at least six weeks prior to conception and/or pregnancy.
Birth defects which have been associated with both Provigil and Nuvigil:
Cleft Lip or Palate
Hypospadias
Congenital Heart Defects
Microcephaly
Multi-Organ Hypersensitivity, Skin Rashes and Stevens-Johnson Syndrome
In 2007, after reviewing studies and adverse event reporting through its FAERS system, the FDA revised the labeling for both Provigil and Nuvigil to include information and warnings about serious rashes requiring hospitalization as well as Stevens-Johnson Syndrome (SJS).
SJS is a rare and severe skin reaction to a particular medication. It is an acute inflammatory condition linked with hypersensitive skin reactions. It is typically characterized by widespread blisters on the face and trunk of the body. These red/purple pustules which form over the body are intensely painful. As the reaction progresses, it takes up inside the mucus membranes and can spark blisters in the mouth, nose, eyes, and genitals. SJS requires hospitalization and the recovery time from an SJS reaction can persist from anywhere from several painful weeks to months.
In addition to SJS, the FDA’s label warning includes cautionary language concerning Toxic Epidermal Necrosis (TEN) – similar to SJS, and Drug Reaction with Eosinophilia (DRESS). DRESS, also referred to as “multi-organ hypersensitivity” is typically characterized by fever, rash, lymphadenopathy, and facial swelling alongside other maladies such as hepatitis, nephritis, and myocarditis.
Mental Health and Psychiatric Symptoms
During clinical trials for Nuvigil, some patients reported anxiety, agitation, nervousness, and irritability while on the drug. Other patients during trials reported issues with depression and suicidal ideation. The FDA expressed that caution should be exercised with Nuvigil when it is given to patients with a history of psychosis, depression, or mania and that if psychiatric symptoms emerge – patients and their physicians should consider discontinuing use. These same label warnings extend to Provigil as well.
Cardiovascular Health and Reactions
Some of the clinical subjects involved in the modafinil trial reported adverse cardiac reactions, including chest pain, palpitations, dyspnea, and transient ischemic T-wave changes on the electrocardiogram. The subjects involved also suffered from issues involving mitral valve prolapse or left ventricular hypertrophy. Accordingly, the FDA warns that patients suffering from these maladies should avoid Nuvigil and Provigil, especially if they have had prior issues with stimulants.
Analysis of studies conducted during trials of Nuvigil revealed that patients experienced “small average increases” in mean blood pressure. Another cohort of patients required new or increased use of blood-pressure medication to reduce hypertension. The FDA warns that caution should be exercised before prescribing either Nuvigil or Provigil to patients with known cardiovascular disease or similar issues.
Attorneys across the United States are taking notice of claims that popular “wakefulness” medications, Provigil and Nuvigil may be associated with increased incidences of birth defects. Although at the moment, no multidistrict litigation (MDL) or class-action lawsuits have been filed relative to these claims of birth defects, attorneys have taken it upon themselves to investigate these issues further and are accepting cases.
Provigil is the product name for the drug modafinil, an oral tablet that promotes wakefulness. Nuvigil is the product name for the drug armodafinil – also an oral tablet prescribed for patients having issues with daytime wakefulness. Provigil is manufactured by Teva Pharmaceuticals USA, Inc. and Nuvigil by Cephalon, Inc. (now a subsidiary of Teva). It is not known how either medication works to keep a person awake. However, they are thought to work by affecting certain substances in the brain that control the sleep and wake cycle through dopamine manipulation.
The FDA and Birth Defects
The U.S. Food and Drug Administration (FDA) classifies both Nuvigil and Provigil as “Category C” drugs. This means that the FDA has concerns about the use of both drugs during pregnancy, but will not state that a clear safety hazard exists on the basis of evidence. Nonetheless, both Nuvigil and Provigil have been associated with the following birth defects:
Cleft Lip or Palate
Hypospadias
Congenital Heart Defects
Microcephaly
In 2009, the FDA expressed enough concern about this association that it established a formal “pregnancy registry” for modafinil and armodafinil in order to gather additional information on the potential ramifications for pregnancy and fetal development.
Congenital Heart Defects
Congenital Heart Defects (also referred to as “CHD”) are present at birth in infants and can have a substantial impact on the function of how blood flows into a baby’s heart and through the rest of its body. Types of CHD include the following:
Atrial Septal Defect
Atrioventricular Septal Defect
Coarctation of the Aorta
Double-outlet Right Ventricle
d-Transposition of the Great Arteries
Ebstein Anomaly
Hypoplastic Left Heart Syndrome
Interrupted Aortic Arch
Pulmonary Artesia
Single Ventricle
Tetralogy of Fallot
Total Anomalous Pulmonary Venous Return
Tricuspid Atresia
Truncus Arteriosus
Ventricular Septal Defect
Treatment options for CHD will depend upon the type and severity of the defect. Infants and children may require multiple surgeries to repair the heart or blood vessels. Furthermore, even though a heart defect can be repaired, treatment may not result in a cure. Children with CHD may develop other heart issues over time and require additional surgeries. With that in mind, however, many children born with CHD go on to lead independent lives with little or no difficulty.
Microcephaly
Microcephaly is a condition where a baby’s head is much smaller than is expected. This condition can occur because the baby’s brain has not developed properly during pregnancy or shortly after birth. In severe cases of microcephaly, a baby can be left with severe and life-threatening brain damage. Depending upon the severity, however, babies with microcephaly can also suffer from seizures; developmental delay; intellectual disability; problems with movement and balance; difficulty swallowing; hearing loss; and vision problems.
Microcephaly is a lifelong condition and there is no known cure or standard treatment. More severely affected babies will often require care and treatment focused on managing their health issues; as well as therapy to help maximize their physical and intellectual abilities.
Hypospadias
Hypospadias is a birth defect in boys impacting the position of the opening of the urethra. Babies born with hypospadias can form the opening to the urethra somewhere near the head of the penis (subcoronal); along the shaft of the penis (midshaft); or where the penis and the scrotum meet (penoscrotal). Additionally, hypospadias can result in curvature of the penis and abnormal spraying of urine. Hypospadias can be treated with surgery to correct the defect and is usually performed between the ages of 3-18 months old.
Cleft Lip and Cleft Palate
Children born with a cleft lip or cleft palate (sometimes in combination with each other) often have problems feeding and speaking clearly and may have regular ear infections. Both are birth defects that occur when a baby’s lip or mouth do not form properly during pregnancy. As a baby develops during pregnancy, facial tissue forms on each side of the head and join together to make the face. A cleft lip occurs when this tissue does not join completely before birth resulting in an opening in the upper lip. A cleft palate results when the tissue in the roof of the mouth similarly does not join together completely.
Depending upon the severity of the cleft and the existence of other birth defects, surgery can usually be an option for treatment within the first 12-18 months of life. With treatment, most children with clefts can expect to do well and live a happy life.
Anti-Trust Lawsuit
Although there are no large class-actions or MDLs involving birth defects yet, the manufacturers of Provigil and Nuvigil, Teva Pharmaceuticals, and Cephalon (along with generic manufacturers Mylan Laboratories and Ranbaxy Pharmaceuticals) recently paid over $134 million to settle an anti-trust lawsuit brought by the State of California. The lawsuit accused the companies of colluding to keep a generic version of Provigil from coming to the market sooner – a move which would have benefited consumers.
Hernia repair is one of the most common surgical procedures performed in the United States and it is estimated that over 20 million of them occur globally each year. Surgical meshes have been the preferred repair format by the medical profession for over 100 years and more than 80% of hernia repairs in the U.S. use mesh products. Accordingly, a great deal of research over the decades has been focused on developing new meshes made from both organic as well as synthetic materials.
Researchers and surgeons have examined the use of metals, polymers, and biodegradable materials for years as the basis for mesh that is simultaneously resistant to infection will maintain tensile strength, and will rapidly assimilate/incorporate into the surrounding tissue. In the 1950s, Dr. Francis Usher first examined the use of materials such as Nylon, Orlon, Dacron, and Teflon as possible mesh candidate materials. Usher eventually settled on a material known as Marlex and within two years introduced the first marlex-based woven hernia mesh.
On the basis of his work with Marlex, Dr. Usher later discovered that polypropylene mesh offered even more advantages due to its rapid incorporation into surrounding tissue and ease of sterilization. By 1998, research into polypropylene mesh materials had advanced enough that next-generation “lightweight” polypropylene hernia meshes were introduced into the market, largely through the U.S. Food and Drug Administration’s (FDA) “fast track” 510(k) clearance process.
Today there are more than 70 types of mesh on the market. However, despite their prevalence in hernia repair procedures, meshes – and in particular, ones made from polypropylene, have not all proven to be a huge benefit for patients. Some polypropylene mesh products have been linked with serious side effects that include severe pain, infections, tissue fusion, organ perforation, and worse. At the moment, three mesh manufacturers: Ethicon (Johnson & Johnson); Atrium Medical, and Davol (C.R. Bard) are embroiled in large-scale multidistrict litigation (MDL) concerning some of their best-selling hernia mesh products.
Polypropylene Basics
Polypropylene is a “thermoplastic” meaning that at high temperatures its form can be easily manipulated, extruded, or molded – later solidifying when it cools down. It is used in a variety of situations and consumer products ranging from essential parts used in the automotive industry to clothing and even in the surgical mesh.
Polypropylene is typically manufactured either through injection molding or using modern printing/cutting devices called “CNC” machines (Computer Numerical Control). It is preferred for its properties in the surgical setting which include: greater elasticity and toughness; as well as resistance to fatigue. Additionally, polypropylene is relatively inexpensive – making it even more desirable in the highly competitive and lucrative hernia mesh market.
Use of Polypropylene Mesh in Hernia Repair Procedures
Generally, surgical mesh is used to repair hernias in either a laparoscopic or open repair setting. In a laparoscopic procedure, a surgeon will make small incisions into the abdomen with surgical tools that can both repair the hernia and insert/set the mesh device. Open hernia repairs are more invasive and involve a larger incision in the abdomen to either suture the hernia or place a surgical mesh.
Polypropylene mesh is considered to be a “permanent” mesh material meaning it is non-absorbable. Permanent materials like polypropylene have virtues in their strength and ability to be easily manipulated. The size of the pores in polypropylene mesh can have a substantial impact on the reaction of surrounding tissue upon implantation. Smaller pores can result in a strong inflammatory response that can reduce the growth of surrounding tissue. Polypropylene hernia mesh made with larger pores can reduce the inflammatory response but inhibit fibrous tissue growth.
Polypropylene mesh can also be manufactured using a knitting or weaving process which will influence the size of pores and flexibility. Knitted mesh is more porous and flexible, while the woven mesh is generally stronger – but less adept at promoting fibrous tissue growth.
Permanent synthetic mesh materials like polypropylene are often combined with other absorbable materials to create “composite” meshes which, it is believed, will limit issues with inflammation, while promoting the strength and flexibility of the polypropylene. Typically, absorbable materials such as Dexon or Vicryl are used, which will completely degrade over time.
Examples of composite mesh products include:
Issues with Polypropylene in Hernia Repair
Most permanent meshes made with polypropylene were “fast-tracked” through the FDA’s 510(k) clearance process meaning that they went to market without rigorous testing or clinical trials. Many issues with synthetic permanent meshes were overlooked prior to implantation and many of them were not discovered until revealed in “post-market” surveillance required of manufacturers by the FDA. It is largely this type of ongoing review which has unmasked some of the more serious side effects and complications associated with polypropylene meshes.
Propylene Mesh Adhesion
Synthetic meshes made with polypropylene are associated with an increased risk of adhesion in patients. Adhesions are scar tissue that forms around the synthetic mesh and, in some instances, cause tissue in the abdomen to “stick” or bind together. This can result in small or large intestines clumping and pulling on each other causing intense chronic pain. Adhesion can also result in a serious abdominal infection known as peritonitis.
Adhesion can also cause either partial or complete bowel obstruction. Complete bowel obstruction can lead to infections such as sepsis and requires surgery to restore blood flow to the intestines.
Propylene Mesh Migration
Typically following laparoscopic procedures, polypropylene mesh can fail to properly adhere to surrounding tissue. This failure then leads to what is called “migration” as the mesh moves from its original insertion point and moves around the abdomen wreaking havoc on the abdominal cavity with infections and abscesses. In some cases, migration can only be remedied with additional surgery that can even be as dramatic as bowel resection.
Propylene Mesh Fistula
Fistulas are abnormal connections between abdominal organs and the intestines which can result when polypropylene mesh “erodes” into the gastrointestinal tract. Depending upon the location of a fistula, fluid can leak into body cavities and inhibit their normal performance. Fistulas can cause diarrhea or severe dehydration.
Propylene Mesh and Bowel Perforation
Bowel perforations are holes that develop in the large intestine which cause severe and even deadly abdominal infections when the contents spill out into the surrounding cavity. Surgeons will typically rush into surgery once a bowel perforation is detected and perform an ileostomy or colostomy to affect tissue healing.
Polypropylene Mesh Recalls and the FDA
Atrium C-Qur
The FDA warned Atrium, the manufacturer of the C-Qur mesh product line, of infection and sterility issues as far back as 2012. Most of the issues related to Atrium’s choice of the manufacturing production line and poor hygiene standards. After Atrium failed to remediate those issues, the FDA issued a Class II recall and sued the company over its poor quality control.
Ethicon/Johnson & Johnson Physiomesh Recall
Ethicon voluntarily recalled its Physiomesh products in 2016 on the heels of a spate of studies which suggested that the permanent synthetic meshes suffered from higher-than-normal rates of revision surgeries and complications.
E-Cigarettes and vaping surged onto the American market in 2007 and immediately enjoyed huge success with the public. Whatever success early e-cigarettes enjoyed, however, was nothing compared to the market gallop that followed the introduction of Juul and its particular brand of cartridge-based nicotine delivery. Juul’s rapid adoption by the vaping public accounts for about 40% of the e-cigarette market and in 2018 its parent company, Juul Labs, Inc. was valued at $15 billion.
Throughout vaping’s early days, e-cigarette manufacturers frequently touted their products as “safe” or “safer than tobacco”. These claims went largely unchallenged until recently. Now, e-cigarette users and their families publicly confront manufacturers about their products and the horrible suffering that they believe comes from vaping.
Additionally, public health officials throughout the United States have started to thoroughly document and study some of the associations they are seeing between vaping, addiction, and respiratory distress:
The American Thoracic Society (ATS) published an article that studied the potential connection between e-cigarette use and Bronchiolitis Obliterans Organizing Pneumonia (BOOP) – a rare lung disorder that makes breathing more difficult.
In November 2019, a respected medical journal documented its extensive look at the bleak long-term health picture for Vaping Associated Lung Injury (EVALI) in the United States. The Centers for Disease Control (CDC) and New England Journal of Medicine have both conducted research linking a thickening ingredient in some vaping products, Vitamin E Acetate, with EVALI. EVALI sufferers frequently complain of symptoms such as cough, chest pain, and shortness of breath.
The December 2019 Mayo Clinic proceedings examined the potential for respiratory distress associated with vaping. Among its findings, the journal concluded that the incidence of vaping-related lung injury is increasing and that e-cigarette compounds present a litany of detrimental effects for human health.
With the rapidly advancing understanding of what vaping products are and the magnitude of the potential harm associated with them, federal and state authorities have stepped-up efforts to either limit access to vaping products or prohibit their use in most public settings.
Federal Regulation of E-Cigarettes and Juul
The U.S. Food and Drug Administration (FDA) has taken the lead role in federal efforts to regulate the e-cigarette and vaping industries. The agency designates vaping devices broadly as “Electronic Nicotine Delivery Systems” (ENDS). In September 2019, then-acting FDA Commissioner, Ned Sharpless, M.D., stated that after witnessing a steady decline in the number of children and young adults using tobacco products, the FDA was seeing a sharp increase in their adoption of ENDS use. Accordingly, oversight of ENDS by the FDA is now a top priority for the agency and involves: developing more science; educating the public, and aggressively enforcing rules on marketing and access to ENDS by children.
In particular, these are some of the ENDS strategies which form the FDA’s approach:
Restricting Youth Access to ENDS
As of August 8, 2016, it is illegal to sell ENDS to anyone under the age of 18 (in some states, the age ranges as high as 19 or 21). Retailers are also legally responsible to verify the age of anyone under the age of 27 purchasing ENDS.
FDA Review of ENDS Products
The Tobacco Control Act, which became effective in August 2016, requires that any ENDS product which wasn’t on the market as of February 15, 2007, must be authorized by the FDA in order to be on the market. Implementation of this requirement has been slow, and ENDS which were on the market before enactment of the Tobacco Control Act technically have more leeway with enforcement. However, in 2019, a federal court in Maryland ordered that applications for ENDS (as well as other tobacco products) were to have been filed with the FDA no later than May 12, 2020.
Preventing Youth ENDS Use
A key facet of the FDA’s ENDS strategy involves addressing the sharp increase in e-cigarette use by teenagers. Part of the agency’s “Youth Tobacco Prevention Plan” focuses on curbing access to tobacco product youth marketing. To date, the FDA has taken some serious action related to limiting youth access to ENDS:
Working with eBay to remove Juul listings and prevent new ones.
Requiring Juul and other ENDS manufacturers to submit documentation on marketing and research of ENDS.
Issuing warning letters to companies which market e-liquids with misleading imagery and packaging that mimicked things appealing to children, such as candy; cookies; juice boxes, and kid-friendly cereals.
Issuing warning letters to companies that manufacture/market/sell ENDS liquids with misleading labeling that imitates prescription cough syrup.
FDA Ban on Flavored Cartridges
On January 2, 2020, the FDA announced the ban of any flavored, cartridge-based ENDS product, other than tobacco or menthol flavorings. The agency has signaled that the ban will be an enforcement priority for the agency.
FDA Investigation Over Possible Juul LInk to Seizures
Bloomberg News obtained communications and memoranda between FDA officials in October 2018 detailing three cases of seizures alongside significant Juul use. While the FDA documentation did not detail any causality between Juul and the seizures, they believe that at a minimum there was an “association” with Juul. Over the next few months, the FDA uncovered an additional 32 reports of e-cigarette use that were believed to be linked to seizures. The FDA announced an investigation into the link between seizures and vaping in April 2019.
State and Local Government Bans on Juul and Other E-Cigarettes
In recent years, various state and local governments have taken a range of approaches to regulating Juul use and vaping in general. Most have adopted regulations limiting vaping in public places largely in the same fashion that they limit the use of tobacco publicly already.
Massachusetts became the first state to place restrictions on the sale of flavored tobacco, including menthol, in November 2019. It was followed in 2020 by New York, New Jersey, and Rhode Island. Later in 2020, California became the first state to ban the sale of flavored e-cigarettes and menthol cigarettes. New York, California, and New Jersey also ban vaping in public areas including bars and restaurants, similar to existing state tobacco use prohibitions. Additionally, these states have enacted statewide vaping bans that generally mimic preexisting bans on public smoking:
Oregon
Utah
North Dakota
Vermont
Maine
Delaware
Of the remaining states, many permit local municipalities to enact regulations limiting the sale of vaping implements and e-cigarette use. It is estimated that at least 300 local communities have taken up restrictions on vaping and e-cigarette use.
Valsartan is a medication that is part of a broader class of drugs known as Angiotensin II Receptor Blockers (“ARBs”). Originally, Valsartan was marketed in the United States under the brand name Diovan, although it is now widely available in its generic format. It is usually prescribed as part of a regimen to combat high blood pressure and hypertensive disorders. However, it can also be used to combat issues associated with Chronic Kidney Disease (CKD) and End-Stage Renal Disease (ESRD) in patients suffering from type-2 diabetes.
ARBs like Valsartan are very popular and have been prescribed to millions of Americans over the years. The medical community considers Valsartan to be a valuable tool to help combat a range of cardiovascular and other maladies frequently associated with type-2 diabetes.
Very recently, however, Valsartan’s generally unblemished reputation has come under intense scrutiny after certain batches of generic medication were found to be contaminated with N-Nitrosodimethylamine (NDMA), an extremely potent carcinogen. It is believed that improper manufacturing processes at plants in Zhejiang, China, and Telangana, India, are to blame for the NDMA contamination. These factories were outsourced by generic drug manufacturers to maximize the profitability of their brands and operated with little or no oversight or monitoring for safety and quality. Consequently, contaminated medications made their way through the supply chain and into batches circulated through the United States, Canada, and Europe.
As a result, in 2018, the U.S. Food and Drug Administration (FDA) began a series of voluntary recalls and alerted consumers and the medical community to be alert about contamination that may have already made it onto the market.
Drugs and Manufacturers Subject to the FDA Recall
It is very important to remember that not every batch of Valsartan was contaminated with NDMA. On certain batches and certain manufacturers were subject to testing and recall. Some of the manufacturers included on the FDA recall list include:
Teva Pharmaceuticals (Major Pharmaceuticals on the label)
Prinston Pharmaceutical, Inc. (Solco Healthcare, LLC on the label)
Mylan Pharmaceuticals, Inc.
RemedyRepack, Inc.
Teva Pharmaceuticals USA/Actavis
Torrent Pharmaceuticals Limited
AvKare (Teva/Actavis)
A-S Medication Solutions, LLC
Bryant Ranch Prepack, Inc.
NuCare Pharmaceuticals, Inc.
H.J. Harkins Company, Inc.
PharmaPac
Hetero Labs, Inc.
Preferred Pharmaceuticals, Inc.
Northwind Pharmaceuticals, Inc.
Aurobindo Pharma USA, Inc.
The complete list of recalled batches and manufacturers can be found here.
What is the Cancer Risk from NDMA Contamination?
NDMA is an organic chemical that is listed by the International Agency for Research on Cancer (IARC) as a group 2A carcinogen, meaning it is likely to cause cancer in humans because research has shown it to cause cancer in animals. In animal studies, NDMA has been shown to be acutely toxic to rats and even short bursts of exposure can lead to multiple organ damage in other animals. NDMA can occur both in nature or as the result of industrial manufacturing processes.
With that in mind, the FDA has offered some perspective on the risk associated with contaminated ARBs. In its updated announcement, the agency estimated that if 8,000 patients took 320mg of valsartan (the highest dose) contaminated with NDMA, there may be one additional cancer case during the lifetimes of those patients. The estimate is based upon average impurity levels in a single tablet of valsartan.
Additionally, the risk for developing certain types of cancer in humans can be attributed to a number of factors: genetic predisposition; environment; smoking, drinking, and eating habits; and obesity. It is, therefore, difficult to pin the risk for a specific type of cancer on NDMA contamination in Valsartan.
How Can I Tell if I Have a Recalled Batch of Valsartan?
Consumers can search the FDA’s Valsartan recall website here to find out which lot numbers were impacted by the recall as well as read the FDA’s official announcement. Next, they will want to look at their own drug containers to see if there is information indicating that they are part of a recalled lot.
Bottles and Vials:
Drug bottles will usually have a lot number printed next to the expiration date, either next to the barcode or underneath the dosing instructions.
Blister Packs:
Medication in blister packs will usually have the lot numbers and expiration dates printed on the foil side of the backings.
Cream and Gel Tubes:
Expiration dates and lot numbers on medications sealed in tubes, such as creams and gels, will usually be positioned at the end furthest from the cap – near what is called the “crimp”.
What Should I Do if I Have Recalled Valsartan?
If you believe you have contaminated or recalled Valsartan, you should immediately contact your physician. Make sure you have your packaging and prescription information ready for them in case he or she asks for it.
Your physician will be able to give you guidance on what next steps to take to replace your medication as well as discuss any symptoms you may be experiencing. Furthermore, your physician can give you advice on how to properly dispose of any contaminated medication.
Adult use of combustible tobacco products, such as cigarettes has been on a continuous decline in the United States since the first Surgeon General’s report was released in 1964. In 2018, cigarette smoking among adults in the U.S. fell to 14%, the lowest on record for available data. However, this trend has been augmented by e-cigarettes, sometimes referred to as: e-cigs; vapes; e-hookas; vape pens; or by the brand name “Juul”; which entered the market in the U.S. around 2007. As of 2018, about 3.2% of American adults reported that they are regular e-cigarette users. Approximately half of adults who use e-cigarettes also smoke combustible tobacco – a behavior known as “dual-use”.
For many years, the use of e-cigarettes and vaping was touted (largely by manufacturers) as a safe alternative to smoking, and a useful tool to help with tobacco smoking cessation. While much remains to be learned about the long term health consequences of vaping, evolving research suggests that the increased exposure to nicotine, in combination with the aerosolized compounds released into the lungs by vaping, nonetheless present the potential for serious health consequences.
Because vaping is a much more sophisticated and efficient method for the delivery of nicotine, quitting can be quite a challenge for adults as well as teens. Nicotine addiction is a well-documented phenomenon as is nicotine withdrawal. Accordingly, if you are thinking about quitting your vaping habit – it helps to understand the effects of nicotine as well as have a plan for successfully countering nicotine withdrawal.
How Addictive Is Vaping?
E-cigarettes contain nicotine just like regular cigarettes. Research on nicotine suggests it may be as addictive as heroin and cocaine. Because of the vaporizing mechanism in e-cigarettes, users tend to receive much higher concentrations of nicotine than they would from an ordinary tobacco cigarette. Furthermore, users of e-cigarettes can even buy extra-strength nicotine cartridges or augment the voltage of the e-cigarette to increase the amount of nicotine.
Nicotine is dangerous for adults as well as teens. However, it presents particular problems for early brain development when it is used by teens. Adolescent brains tend to be more sensitive to “rewards” which trigger dopamine in younger brains. Dopamine is a well-understood neurotransmitter that gives the brain a “feel-good” feeling and encourages the brain to repeat actions that promote dopamine release. The more dopamine triggers in the brain, the more association with nicotine rewards become engrained. When addicted e-cigarette users, and in particular, teens, attempt to quit vaping, nicotine cravings become a huge problem in the absence of a consistent dopamine rush.
What Are the Potential Dangers?
Compared to regular cigarettes and the volumes of research that have emerged over several decades, e-cigarettes have only been on the market for a relatively short amount of time. Even so, doctors and scientists have been successfully accumulating copious research on e-cigarettes in an effort to understand more fully what their impact is on human health.
Nicotine Exposure
Even short-term exposure to nicotine has been demonstrated to include tremors and an increase in heart rate, blood pressure, and respiration. Nicotine is a teratogen meaning it can promote the growth of tumors. Furthermore, nicotine exposure for pregnant mothers and small children can have long term impacts on fetal brain development or even potentially lethal consequences if ingested.
BOOP
The American Thoracic Society (ATS) published an article on the prevalence of Bronchiolitis Obliterans Organizing Pneumonia (BOOP) in patients claiming they use e-cigarettes. BOOP is a rare inflammatory lung disorder involving flu-like symptoms and coughing that make breathing very difficult in sufferers.
EVALI
The Journal of the Missouri State Medical Association’s November 2019 edition gave an extensive look into the increasingly bleak outlook for Vaping Associated Lung Injury (EVALI) in the United States. The articles noted that as of its publication, there were 2,051 cases of e-cigarette or vaping lung product uses associated with lung injury (with 39 reported deaths) in the U.S. Overwhelmingly, EVALI patients complain of symptoms like cough, chest pain, and shortness of breath. Of the documented cases expressing EVALI, 86% of the patients reported using THC-containing products. In February 2019, the New England Journal of Medicine and the Centers for Disease Control (CDC) had both established research pieces linking Vitamin E Acetate, a thickening fluid used predominantly in THC vaping products with EVALI.
How Difficult Is It to Quit Vaping?
Again, due to the short amount of time most e-cigarette products have been on the market, hard data on vaping and quitting is mostly still emerging. However, the American Lung Association has noted that it is observing people having a greater difficulty trying to quit vaping than they did with combustible cigarettes. E-cigarette users tend to inhale more deeply and hold the vapor for longer periods of time than ordinary tobacco smoke. Accordingly, they tend to dose the brain with substantially more nicotine, more frequently throughout the day. Consequently, the symptoms and effects of nicotine withdrawal on e-cigarette users may even be more profound than they are on ordinary tobacco smokers.
While the U.S. Food and Drug Administration (FDA) has approved nicotine patches, gum and lozenges to help quit combustible tobacco use, no similar method has been approved to assist vapers with quitting.
What Are Some Methods for Quitting Vaping?
Because nicotine is addictive, the human brain and body become conditioned to its presence. For most users of nicotine, removal of nicotine from their bodily systems will come with some immediate side effects. For e-cigarette users serious about quitting, it helps to first reconcile all of the reasons why you should quit – and then have a plan for how you are going to address and cope with some of the side-effects of kicking the nicotine habit.
Step One – Tell Yourself Why You Want to Quit
Determining why you want to quit using nicotine is usually a good place to start on the path to successfully kick the habit. Perhaps you are concerned with the litany of potential ill-health effects connected with vaping. Maybe you’re thinking that if you quit, you’ll save a lot of money or help protect loved ones from second-hand exposure to nicotine. There is no wrong reason to quit.
Step Two – Understand the Challenges That Come with Nicotine Withdrawal
In the absence of nicotine after vaping, the body and mind must adjust. This adjustment is called nicotine withdrawal and it is usually accompanied by nicotine cravings. Typical nicotine withdrawal symptoms can include:
Feeling irritable
Headaches
Increased sweating
Anxiety
Sadness
Feeling tired
Difficulty with concentration
Insomnia or difficulty sleeping
Increased hunger
Intense cravings for e-cigarettes
Step Three – Have a Plan to Cope with Nicotine Withdrawal
Withdrawal symptoms will vary from person-to-person. Some will enjoy success going “cold-turkey” while others will struggle with cravings and other symptoms. With that in mind, cravings will tend to wear off over time the longer your body has to adjust to being nicotine-free.
Some tips for creating a strategy to kick the habit include:
Build a Support Team
You don’t have to deal with nicotine withdrawal alone. Reach out to family and friends to let them know what’s happening and what type of support you would appreciate from them. Remember to always be gracious for their help.
Talk to Your Physician
Ask your doctor if he or she has any ideas or support resources to help you kick the vaping habit.
Exercise
Physical activity is an excellent way to stave off craving impulses. Jogging, lifting weights, or going for short walks can help release brain chemicals which will give you the same “feel good” impulse as the dopamine cycle triggered by nicotine.
Coping with Stress
Vaping is frequently a solution for users who feel “stressed out”. This leads to a vicious cycle of cravings. Cultivate meditation or deep breathing exercises to help you better cope with stressful situations to avoid the temptation to vape.
Distractions
Cravings are usually a moment-to-moment problem, and generally, only last a minute or two. Finding distractions, like reading, listening to music, or solving a puzzle can help divert your mind long enough for the craving symptoms to pass.
Acknowledge Your Success
Take time to recognize your success getting out from under the yoke of vaping. Whether it’s the first few hours or the first 1,000 days – be sure to congratulate yourself.
Proton Pump Inhibitors (PPIs) are drugs first developed in the mid-1970s which are designed to limit the production of digestive acid by blocking a key enzyme in the stomach wall. Specifically, PPIs stop certain cells in the stomach lining from pumping or producing acid. Since first gaining approval by the U.S. Food and Drug Administration (FDA), PPIs such as omeprazole and esomeprazole have experienced extreme popularity both in their prescription and over-the-counter (OTC) formats with patients. Prilosec (omeprazole) generated over $26 billion for AstraZeneca before falling “off-patent” – only to be replaced with Prilosec (esomeprazole) which generated another $48 billion in sales for the company.
Without a doubt, PPIs have been a huge commercial success and millions have used them as part of a comprehensive strategy to combat peptic ulcer disease, non-ulcer dyspepsia, and Gastroesophageal Reflux Disease (GERD) among other digestive afflictions. However, PPIs also come with a range of possible side effects: some common, others not so common. Furthermore, recent studies regarding the long-term use of PPIs have suggested possible adverse side-effects which have the potential to be life-altering or worse.
More Common Side Effects
Documented side effects for PPIs include the following:
Headache
Nausea
Stomach Pain
Gas
Constipation
Diarrhea
Rash
Vomiting
Constipation
Fever
Cold or Flu-like Symptoms
Other Possible Serious Side Effects
Acute Interstitial Nephritis, Chronic Kidney Disease, and End-Stage Renal Disease
Recent reporting and studies have raised concerns about a possible association between PPI use and acute injury to the kidneys. In particular, several case reports have suggested a link between PPIs and the development of Acute Interstitial Nephritis (AIN). AIN is a kidney disorder in which the spaces between the kidney tubules become inflamed and swollen. Symptoms of AIN associated with PPI use include:
Malaise
Fever
Nausea
Lethargy
Weight Loss
If left unchecked, AIN can progress to Chronic Kidney Disease (CKD), a condition that encompasses the gradual loss of kidney function. Unfortunately, the symptoms of CKD are not always readily apparent for sufferers and may not become obvious until kidney function has already been substantially impaired. While the onset of CKD is gradual, its effects are serious and it brings a substantially increased risk of death from cardiovascular events.
Long-term suffering with CKD can regrettably lead toward End-Stage Renal Disease (ESRD) otherwise known as complete renal failure. ESRD occurs when a person’s kidneys are no longer able to function properly. ESRD treatment options require either frequent dialysis or a kidney transplant for the patient to survive.
Note: in 2014 the FDA required prescription PPIs to carry warnings on their labels concerning the risk of AIN.
Hypomagnesemia
Hypomagnesemia, otherwise known as magnesium deficiency, is a condition where this important element’s presence in the blood is lower than normal. Magnesium is critical to the operation of the heart, lungs, and kidneys among other critical organs, and is of central function to the body’s metabolism. In 2011, the FDA issued a safety warning concerning the association between PPI use and magnesium deficiency and recommended monitoring of magnesium levels in patients who have been on PPIs for a long duration.
Clostridium Difficile Associated Diarrhea
In 2012, the FDA issued a safety communication concerning increased risk from PPIs and Clostridium Difficile Associated Diarrhea (CDAD). Clostridium difficile is a bacteria that can cause serious diarrhea that does not improve. After reviewing reports from the FDA’s Adverse Event Reporting System (AERS), the agency noted that many reports of patients undergoing treatment with PPIs and who manifested CDAD suggested the possibility of a linkage. It should be noted that most of the reporting involved elderly patients who were also taking doses of broad-spectrum antibiotics or had other conditions that may predispose them to CDAD. However, the FDA could not rule out the role of PPIs in the development of CDAD.
Small Intestine Bacterial Overgrowth
Small Intestine Bacterial Overgrowth (SIBO) is a condition where there is an abnormal increase in the bacterial population of the small intestine. SIBO can occur as a result of surgery or disease and can cause diarrhea, weight loss, and malnutrition. The Mayo Clinic recently reported that PPI use may also carry an increased-risk for SIBO in patients.
Cancer Risk from Long Term Use
There are no definitive research or medical links between PPI use and cancer. However, two studies conducted in 2017 and 2018 included data and conclusions that support further research into any potential relationship between PPIs and gastric cancer. Specifically, researchers at the University of Hong Kong and others in Sweden conducted similar studies examining the relationship between PPIs and H. Pylori infections in the gastrointestinal system. H. Pylori are bacteria that live in the digestive tract and cause ulcers and increase the risk of stomach or esophageal cancer. It is theorized that long-term PPI use can contribute to an increased level of H. Pylori in the digestive tract and possibly, therefore, the increased risk. Although the two research studies arrived at the same conclusion, their findings are not without controversy and have been contradicted by researchers elsewhere.
Heart Attack Risk
In June 2015, the Stanford Medicine journal reported on a data-mining study carried out at Stanford Medical School linking PPIs with an elevated risk of a heart attack. Although researchers were quick to point out that their study did not illustrate a causative link between PPIs and heart attack risk, they stated that the report combed through the health records of nearly 3 million people and found indications that PPI use was associated with a roughly 20% increase in the rate of a subsequent heart-attack in all adult PPI users.
Risk of Fractures of the Hip, Wrist and Spine
The FDA issued a drug safety communication for all PPIs in May 2010, revising the labeling to include safety information about the possibility of increased risk of fractures to the hip, wrist, and spine. The FDA’s decision came on the heels of its own reviews of several studies that reported an increased risk of fractures with PPI use. In fact, the FDA said that some studies found that those of the greatest risk of fracture were those who received high doses of PPIs or used them for a year or more.
Dementia and Cognitive Decline
The Harvard Medical School published an article in 2016 highlighting the findings of a study that shed light on the potential for dementia and cognitive decline with long-term PPI use. Specifically, a 2015 study published in the neurology Journal of the American Medical Association (JAMA) showed a possible association between chronic use of PPIs and dementia risk. Experts compared prescription PPI intake and diagnosis of dementia among approximately 74,000 adults ages 75 and older.
All of the participants in the study were dementia-free at the time that the study commenced. However, follow-up interviews eight years later seemed to indicate that chronic PPI users had a 44% rate of increased risk for dementia. Men were at a slightly higher risk than women and occasional users of PPIs had a much lower risk.
The article publishers and researchers are quick to point out that the study does not mean PPI users will automatically get dementia. It only points to a “statistical association” and the need for ongoing research and discussion about the potential for linkage.
Proton Pump Inhibitors (PPIs) have been aggressively marketed and prescribed to the American public for many years as a potent tool in the fight against Gastro-Esophageal Reflux Disease (GERD) and a host of other digestive disorders. PPI drugs like Prilosec have been a runaway success for global pharmaceutical giants like AstraZeneca, PLC, accounting for over $26 billion in revenue. AstraZeneca liked Prilosec so much, in fact, that as soon as it fell out from under patent protection, it rolled out another PPI just like Prilosec, called Nexium (marketed as “The Purple Pill”) which went on to generate another $48 billion for the firm.
However, years after entering the market and after many millions of doses, clouds have emerged on the PPI horizon. Cumulative medical journal and scholarly studies published over several decades have associated long-term use of PPIs with kidney injuries. Furthermore, in 2014 the U.S. Food and Drug Administration (FDA) required prescription PPIs to carry warnings on their labels concerning Acute Interstitial Nephritis. Against this backdrop of increasingly dire scientific reporting, nearly 14,000 lawsuits alleging that PPIs have caused renal disease and related injuries have been consolidated into one massive multidistrict litigation in federal court in New Jersey (MDL-2789).
PPIs and Potential for Kidney Damage
Patients who take PPIs have demonstrated an increased risk of kidney damage that could lead to kidney failure. Researchers at the University of Buffalo School of Pharmacy have published studies showing that PPI users have a “four-fold” increase in their risk of acute kidney injuries which, in turn, can lead to more consequential injuries such as Chronic Kidney Disease.
Acute Interstitial Nephritis and Chronic Kidney Disease
PPIs have been specifically associated with a condition known as Acute Interstitial Nephritis (AIN) – a kidney disorder in which the spaces between the kidney tubules become swollen (inflamed). The risk of developing AIN from drugs such as PPIs increases over time due to prolonged use. Prolonged AIN symptoms can progress to Chronic Kidney Disease (CKD) a condition that carries with it a substantially increased risk of death and cardiovascular events.
End-Stage Renal Disease
End-Stage Renal Disease (ESRD) is typically the next stage toward complete renal failure following long-term suffering with CKD. Essentially, a sufferer’s kidneys are no longer able to function properly in a way that the body requires. Treatment for ESRD requires either frequent dialysis or a kidney transplant for the patient to survive.
Lawsuits and Allegations
Complaints have been filed in courts across the United States, many of which have been consolidated in MDL-2789, by people suffering from a range of renal maladies including AIN, CKD, and ESRD who also took either prescription or over-the-counter (OTC) versions of PPIs (or both). In their complaints, many sufferers allege that manufacturers knew of the risks of renal damage from PPIs (in particular Nexium) going back to the late 1980s and that research as far back as 1992 associated PPIs with kidney damage. Furthermore, they claim, studies by the Yale School of Medicine in 2006 made findings of a connection between PPIs, AIN, and CKD in most patients. Some of the claims also reference a 2016 study in the Journal of the American Society of Nephrology that found that PPI use, including Nexium, was independently associated with 20%-to-50% higher risk for CKD.
Sufferers allege that, with all of the mounting scientific evidence compiling, that companies like AstraZeneca and other manufacturers either knew or should have known of the increased risk for CKD posed by PPIs. They claim that manufacturers instead took no action to warn doctors or patients of the risk of kidney disease – and even continued to claim that PPIs such as Nexium did not have any associated risks of kidney injury.
Lawsuit Profiles
Hope Butler
A resident of Ohio, Ms. Butler was among the very first to file a PPI lawsuit naming AstraZeneca in the U.S. District Court for the Southern District of Ohio in March 2017. She states in her complaint that she used prescription Nexium between 2010 and December 2016. Ms. Butler filed her lawsuit after her diagnosis with CKD in March 2015 and her discovery of the increased potential for kidney disease associated with PPIs.
Cheryl Lear
Cheryl Lear, a chronic sufferer with GERD, nonsteroidal anti-inflammatory drug-induced gastropathy, and other peptic disorders from Duval County, Florida, filed a lawsuit naming AstraZeneca, Wyeth Pharmaceuticals, and Pfizer, Inc. (among others) in federal court in 2017. She began taking prescription Prilosec in 2012 and later prescription Protonix through September 2013. Ms. Lear filed her lawsuit after suffering several years with acute kidney injuries, culminating with CKD, and upon learning of the potential connection with her long term use of Prilosec and Protonix
Lawsuits Are Still Being Filed
Individuals who have taken either a prescription or OTC PPIs and have suffered from kidney damage or related illnesses may be able to take legal action. Although each potential case is unique, types of compensation sought typically include medical expenses, loss of income, and pain and suffering. Case reviews are free and do not involve any obligation whatsoever.
In the United States, the number of Total Hip Arthroplasty (THA) procedures performed in recent years has increased substantially – especially in a growing number of young patients. Physicians and clinicians believe hip replacement surgery is one of the most cost-effective ways to improve the quality of life in suffering patients. However, although there are generally many benefits to suffering patients from hip replacement surgery – as with any invasive procedure, there are risks and the possibility for complications.
The vast majority of patients who undergo THA find significant pain relief and improvement in mobility following the procedure. Bearing that in mind, there are factors such as patient obesity or other medical conditions such as diabetes, liver disease, heart disease, or other uncemented prostheses which may contribute negatively to the postoperative outcome. Patients are always recommended to develop an open line of communication with their physicians and surgeons to identify specific risks prior to surgery and possibly undertake lifestyle modifications such as quitting smoking or losing weight.
The bottom line for both doctors and patients is to avoid unfortunate complications which can have life-altering consequences as well as the need for follow-up surgical procedures known as “revision” surgery. Below are some of the more significant and unwelcome risks associated with hip replacement surgery:
Blood Clots
Deep Vein Thrombosis (DVT) is a widely recognized risk factor following hip replacement surgery. DVT is a blood clot in the leg that can break loose and become a Pulmonary Embolism (PE) that travels through the body and into the lungs where it can cause illness and death. DVT can occur in any vein in the body, however, they tend to manifest the most often in the lower extremities of the body.
Symptoms of DVT may not be obvious or even recognizable to the patient. In fact, DVTs can occur with no symptoms at all about half of the time. When there are visible symptoms, they usually look/feel like:
Swelling in the leg
Red, discolored, or white skin
A cord in a leg vein that can be felt
Rapid heartbeat
Slight fever
Warm skin
More visible surface veins
A dull ache, tightness, tenderness, or pain in the leg
Any patient with symptoms that concern them should call their physician immediately.
Risk factors for DVT or that may contribute to DVT include obesity, inherited traits that cause clotting, being older than 60, and having Type-A blood.
Patients can take steps to prevent DVT following surgery as well and physicians may prescribe exercise/physical therapy, compression stockings, and anti-clotting medicines to help combat the risk.
Hip Dislocation
Traumatic hip dislocation occurs when the ball of the hip joint is pushed out of the socket and is usually the result of an incident such as an auto collision or a high-impact fall. A dislocated hip can result in life-changing and long-term issues that can be debilitating if not addressed promptly.
Hip dislocation following THA is relatively infrequent among healthy people under the close guidance and care of a physician. However, there tend to be higher rates of dislocation among some sets of hip replacement patients, such as the elderly or those who have suffered from previous hip injuries.
If a patient or physician suspects that a hip joint has dislocated, they will typically conduct a physical exam and order imaging of the hip with either a CT scan or MRI. An orthopaedist usually can manipulate the hip-joint back into place while the patient is under anesthesia. However, if the damage appears to be more severe, revision surgery may be necessary.
Infection
Infection following surgery for THA is a possibility and a very serious problem. Accidental exposure to bacteria such as staphylococcus aureus can occur even in the midst of the most stringent sterilization protocols.
People who live with certain conditions, such as diabetes mellitus; obesity; peripheral vascular disease; or are otherwise immunocompromised; are at greater risk for developing infections even in a hospital setting.
Common symptoms of joint-infection following surgery include:
Increased stiffness and pain
Swelling
Redness
Wound drainage
Fevers, nightsweats and chills
Fatigue
Treatment options for joint-infection depend upon the extent and depth of the infection. Superficial infections in soft tissue are relatively easy to treat with oral antibiotics or even intravenous (IV) antibiotics. For deeper infections, including those within the joint itself, treatment may require surgical treatments such as debridement – or removal of the infected soft tissue and thorough cleaning of implanted devices and spacers.
Damage to Joint Structures
There exists a distinct possibility that soft muscle and joint tissue surrounding the hip will be damaged during surgery. This damage, in some cases, can result in leg weakness or decreased feeling in the leg.
Loosening of the Prosthetic
A new hip joint should fit naturally with the existing bone and surrounding tissue. However, over time, one or both ends of the replaced joint may loosen the bond to the natural bone causing pain or other problems.
When a hip replacement is implanted, it is either pressed or cemented into position to fit tightly into the bone of the thigh or pelvis. A hip replacement may start to loosen due to factors involving: weight, age, sex, and activity levels. Statistics have shown that women, people over 60, and those with a Body Mass Index (BMI) under 25 tend to have the least amount of issues with loosening.
The most common issue connected with the loosening of the hip joint is Osteolysis – a condition akin to the bone around the implant seemingly “melting away”. Because of the weakened bone around the hip joint, it begins to come loose and wobble.
Loosening issues may necessitate a repair surgery known as a Hip Revision. Revision surgery may also be recommended if an infection has developed in the tissue surrounding the joint.
Femur Fracture
Bone fractures in combination with prosthetic joint replacements are referred to as “periprosthetic fractures”. They are generally rare but are a very serious complication of hip replacement surgery. These types of fractures usually occur years after surgery and can be challenging to repair due to the age of the patient. They are usually the result of a fall or other similar trauma. Most cases of periprosthetic fractures require surgery to treat.
Metal-on-Metal Implants and Metallosis
In Metal-on-Metal (MoM) hip implants, the metal ball and metal cup slide against each other during walking or running. This friction between the ball and socket can cause the release of metal particles that will wear off of the device and embed in surrounding tissue as well as metal ions of cobalt and chromium entering the bloodstream. Over time, this leaching of metal from the joint into surrounding tissue causes “Adverse Local Tissue Reaction” (ALTR) and/or “Adverse Reaction to Metal Debris” (ARMD). The bottom line for patients implanted with MoM joints, however, is that they suffer damage and pain, device failure, loosening, and the need for revision surgery. Furthermore, patients implanted with MoM hip joints can also suffer from a condition known as “metallosis” – a potentially fatal complication arising from metallic erosion in the joint which induces pain around the joint, pseudotumors, and a noticeable rash.
Prior to 2016, MoM hip devices marketed in the United States were subject to the FDA’s less rigorous 510(k) clearance process which allowed them to be implanted in human patients without first subjecting them to the same standards of scientific review and lab testing as the FDA’s more rigorous Pre-Market Approval (PMA) process. In May 2016, following numerous recommendations, the FDA required all MoM manufacturers to immediately cease and desist from marketing MoM devices until they can be demonstrably approved under PMA conditions with valid supporting scientific evidence. It is worth noting that to-date, there are no FDA-approved MoM hip replacement devices marketed for use in the United States.
Hip Revision
Despite the overall favorable statistics concerning THA, hip replacement surgery can still fail for a number of reasons. When hip replacement failure occurs, a physician may recommend a second procedure to examine or even remove some of a patient’s prosthesis and replace it with a new device. This second procedure is known as a “revision”.
The hip revision could turn out to be a longer and more complex procedure than even the first surgery. Additionally, there are different types of hip revision surgery depending upon the extent of injury or replacement. In some cases, only parts of a prosthetic joint may be addressed, while in another revision – the entire joint may be replaced.
As discussed earlier, a physician may order a revision on the basis of a range of circumstances, including infection; fracture; loosening; dislocation, or reaction to metallosis. Revision surgery carries similar risks as primary hip replacement surgery. However, the success rate for revision surgery is generally lower due to issues with the structural strength of the bone.
Patients undergoing revision surgery can take certain steps to minimize risks in advance, such as:
Avoiding overuse of the joint
Avoiding sports which involve jumping
Maintaining a healthy weight
Following revision surgery, patients should keep in close contact with their physician and surgeon if additional pain develops suddenly or it appears that an infection has developed.
Surgical mesh devices used to repair hernias have been available for over a century in the United States and hernia repair is one of the most common surgical procedures performed today. In fact, more than 80% of hernia repairs performed in the U.S. use mesh, and, at the moment, there are more than 70 types of meshes commercially available.
It goes without saying that the hernia mesh industry is both profitable and competitive and manufacturers are incentivized to bring as many “new and improved” products to market as soon as possible. Most new hernia mesh brands are pushed through the U.S. Food and Drug Administration’s (FDA) 510(k) clearance or “fast track” process with little testing or laboratory review. Accordingly, hernia mesh devices sometimes present serious medical issues and complications for the patients into whom they are implanted.
Hernia Mesh Adhesion
Adhesions are bands of fibrous scar tissue that sometimes form following abdominal surgery. In some instances, these scars will form tissue that “sticks” or binds together inside of the body. Adhesions make normally slippery internal tissues collect together and can pull on small or large intestines causing intense pain. This condition can also form in people who develop peritonitis, an infection that spreads to the membrane covering the abdominal organs.
In cases where adhesive tissue becomes severe, bowel obstruction can result and cause cramp-like pains as well as other symptoms such as:
Abdominal pain
Nausea and vomiting
Abdominal swelling
Inability to pass gas and/or infrequent bowel movements
Dehydration (dry skin, severe thirst, infrequent urination, swollen/dry tongue)
In cases where adhesive bowel obstruction is partial, surgery may be avoided with rehydration and insertion of a small suction tube through the nose into the stomach to prevent additional bloating. Complete bowel obstruction caused by adhesion often requires surgery to restore blood flow.
Hernia Mesh Contraction
Mesh contraction (sometimes referred to as “mesh shrinkage”) is a phenomenon that, when it occurs, usually does so within two months of being implanted in the body. It is usually characterized by a failure of the implanted mesh to adequately meld with surrounding tissue which results in the mesh no longer covering the hernia location. This often leads to the recurrence of the hernia and further surgery to retrieve the defective mesh and repair the hernia.
Hernia Mesh Migration
Mesh migration occurs when a surgically implanted mesh (typically through laparoscopic implantation) fails to adequately adhere to surrounding tissue and begins to move freely through organ cavities in the abdomen. Migration can result in serious complications for patients, such as erosion into viscous. As a consequence of erosion due to migration, infections and abscesses can form. If treatment for migration and erosion into the bowels is required, it can involve additional procedures such as laparotomy; bowel resection; mesh resection/removal, or anastomosis; followed by another procedure to repair the original hernia.
Hernia Mesh Fistula
Abdominal fistulas can form when a defective hernia mesh fails to properly adhere to surrounding tissue or “erodes” into the gastrointestinal tract. The mesh can cause an abnormal connection between internal organs and the intestines creating fluid leakage into body cavities (or even through the skin). Depending upon the location of the leakage, fistulas may cause diarrhea or poor absorption of nutrients and dehydration. Other fistulas may manifest no symptoms at all and even close on their own after a few weeks or months.
Physicians will ordinarily seek to locate a fistula using barium tracers, CT scans, and fistulograms to closely examine the stomach, bowels, or other areas of the abdomen. Treatment for fistulas may involve antibiotics; immunosuppressants; surgery or intravenous nutritional supplements.
Bowel Perforation Following Hernia Mesh Implantation
Hernia mesh migration and/or erosion can sometimes result in direct trauma to the bowels in the abdomen known as “perforation”. A perforation is a hole that can develop anywhere in your gastrointestinal tract between your throat and your rectum. When that hole or puncture occurs on your large intestine, it is a “bowel perforation”. A perforated bowel can cause the contents of the bowel to spill into your abdomen resulting in an infection known as peritonitis and eventually a more deadly condition known as “sepsis”. Common signs of a perforated bowel are:
Severe stomach pain
Chills
Fever
Nausea
Vomiting
Bowel perforations are considered a medical emergency and physicians will seek to treat them immediately by first running X-rays and bloodwork to determine if an infection has developed. Next surgeons will work to repair the perforation. In some cases, the surgeon will perform an ileostomy or colostomy to empty the contents of the bowel while allowing the tissue to heal.
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