Last Updated December 2, 2020

Reasons for Hip Revision Surgery

Patients who undergo THA can usually expect that their prosthesis will last at least 15-20 years – and in some cases, remain within the patient for the rest of their life. However, in approximately 18% of all hip replacement scenarios, doctors will recommend revision surgery. The most typical factors mitigating in favor of revision are:

Recurrent or Repetitive Dislocation of the Hip Joint

Traumatic hip dislocation can occur where the ball of the hip joint is pushed out of the socket. A dislocated hip can be debilitating if not addressed to put the ball and socket back into proper alignment and ensure proper complementation by surrounding muscle and ligament tissue.

Fortunately, dislocation is a relatively infrequent phenomenon among younger patients who follow proper care guidelines given by their physician. However, among elderly patients or those who have THA following fracture, rates of dislocation rise precipitously. Furthermore, patients who have already suffered dislocation are more likely to suffer additional dislocations without corrective surgery as surrounding tissue becomes increasingly disrupted.

Infection

Infection resulting from any surgical setting, including hip replacement, is a very real problem and a possibility all patients must face. Exposure to infectious bacterial agents can occur even in surgical theaters observing even the most stringent sterilization protocols. Additionally, patients who suffer from conditions such as diabetes mellitus, obesity, peripheral vascular disease, or are immunocompromised, may be at even greater than usual risk for infection.

The risk for infection is greatest within the first six weeks following surgery. If infection sets into the prosthesis, the surgeon will usually recommend a battery of tests to identify the type of infectious agent at work, possibly including an aspiration of joint fluid from the hip joint itself.

Once the surgical team identifies the type of infection, they will consider a range of treatment options. Chief among these is the use of targeted antibiotics and revision surgery to eradicate the infection. Typically revision procedures to address infection include:

• Surgical cleansing with intravenous antibiotics.
• A complete exchange of the hip replacement device:
  • Two-Stage: The surgeon will remove the device and infection then clean the bone. A temporary cement spacer will be implanted while the patient undergoes a six-week course of intravenous antibiotics.  Following the antibiotic treatment, a new prosthetic device will be implanted.
  • Single Stage: This procedure entails the removal of the device, total cleansing of the infected joint, and replacement with a new device all at once. Like the two-stage procedure, patients will require six-to-eight weeks of intravenous antibiotics afterward.

Wear and Tear/Loosening

The metal, ceramic and plastic components of a hip joint replacement will rub against each other as part of the normal function of the prosthesis. Over time, however, joint movement can slowly wear down parts of the implant increasing the risk of failure or revision.  

Typical factors contributing to excessive wear and/or loosening include:

• Excessive vigorous physical activity by younger/more active patients
• Obesity
• The type of device (i.e. “metal on metal” vs. “metal on polyethylene” vs “metal on ceramic”)

In some cases, wear and tear from the device will introduce synthetic particles into surrounding tissue as well as the patient’s bloodstream. These particles can then trigger an immune response that fosters progressively worse conditions such as osteolysis (destruction of surrounding bone tissue).

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 which 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.

What to Expect with Hip Revision Surgery

Pre-Operative Protocols

In the weeks and days prior to revision surgery, doctors will order a variety of tests such as X-rays, CT and bone scans to identify the issues which they seek to address during the procedure. Additionally, they may ask for a routine aspiration of the joint to rule out infection risks prior to surgery. Patients should make arrangements for post-surgical assistance around the home and consult with their personal physician concerning medications or other relevant physical conditions. It is recommended that patients stop smoking as long as possible before surgery.

The Revision Procedure 

A hip revision can be a longer and more complex procedure than the original THA surgery. A simple revision can just be a swap of liner components.  A more complex revision can be as involved as a total replacement of all components. However, effective planning and coordination between the surgical team and your personal physician can help ward off more serious complications during and after the revision procedure. 

Post-Operative Matters

Following revision surgery, patients may be allowed to sit up out of bed or even walk the very next day upon the advice of their surgeon. Some pain, but not excessive pain, is to be expected. Patients are typically discharged to their home or to a rehabilitation hospital within 5-7 days post-revision. Afterward, they will usually transition into a physical therapy regimen accompanied by the use of crutches and canes for walking assistance for as many as six weeks. 

Complications and Risks from Revision Surgery

Revision surgery, like other major procedures, is not without inherent risk.  Possible medical complications associated with any surgery include, but are not limited to:

• Allergic Reactions to Certain Medications
• Blood Loss
• Heart Attacks/Strokes/Kidney Failure/Pneumonia
• Nerve Damage

Risks more commonly associated with THA and revision surgery also include:

• Deep Vein Thrombosis (DVT) is a widely recognized risk factor following hip revision 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.
• Infection following revision surgery 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. Common postoperative infection symptoms include swelling, stiffness, pain, redness, fevers, night sweats, and chills.

Metal-on-Metal Hip Implants and Higher Rates of Revision Surgery

Starting in the early 2000s, several manufacturers aggressively marketed hip-joints through the 510(k) process featuring a “Metal-on-Metal” (MoM) coupling feature between the ball and socket of the joint. In MoM joints, 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 which will wear off of the device and embed in surrounding tissue as well as metal ions of cobalt and chromium entering the bloodstream. 

The bottom line for patients implanted with MoM joints is that they suffer damage and pain, device failure, loosening, and the increased 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.

Recalls and Lawsuits of MoM Hip Replacement Devices

Smith & Nephew Metal-on-Metal and Hip Resurfacing

Smith & Nephew is a United Kingdom-based joint device manufacturer with operations in the United States. In 2017, Smith & Nephew was named a defendant in Multidistrict Litigation (MDL-2775) occurring in federal court in Maryland before Judge Catherine C. Blake. At the center of the litigation naming Smith & Nephew are several hundred claims alleging defects involving the company’s MoM Birmingham Hip Resurfacing (BHR) implants and its R3 hip joint products. The BHR was the subject of a recall for all units implanted between 2006 and 2015 due to high rates of failure and revision surgeries as was the R3 in 2012 due to issues with erosion and metallosis.

Stryker LFIT V40 Femoral Head and Rejuvenate/ABG II Hip Implant

Stryker is a Michigan-based medical device manufacturer that traces its founding back to Dr. Homer Stryker, an orthopedic surgeon, and his device inventions dating back to 1941. Today Stryker is an international giant that claims $14.9 billion in sales in 2019. In 2016, Stryker announced a recall of its LFIT V40 femoral heads manufactured before 2011 following post-market surveillance showing a higher-than-average rate of failure with symptoms in patients similar to those suffering from metallosis. Similarly, Stryker recalled its Rejuvenate and ABG II implants in 2012 (after only 2 years on the market due to post-market research indicating issues common to MoM devices. Both the LFIT V40 and the Rejuvenate/ABG II devices are the subject of ongoing multi-district litigation in federal court in Massachusetts (MDL-2768) and Minnesota (MDL-2441).

DePuy Orthopedics ASR Hip Implant and Pinnacle Hip Implant

DePuy Synthes is a subsidiary of global pharmaceutical and medical device manufacturer Johnson & Johnson. In 2010, DePuy Synthes issued a voluntary global recall for its ASR Acetabular System following evidence that emerged through post-market surveillance that patients were suffering considerable pain, immune system reactions, inflammation, and the need for revision. The symptoms were consistent with MoM injury and potential design flaws. Similarly, Depuy Synthes’ Pinnacle MoM hip implant is alleged to cause a condition called “osteolysis” which occurs when bone surrounding the hip joint dissolves due to instability and metallosis. Pinnacle has not been the subject of a recall as of this date.  However, both the ASR Hip Implant and the Pinnacle Hip Implant are subjects of multi-district litigation in Ohio (MDL-2197) and Texas (MDL-2244).

Zimmer M/L Taper Hip Prosthesis and Versys Femoral Head (MDL-2859)

Indiana-based Zimmer Biomet Holdings, Inc. developed and marketed the Zimmer M/L Taper hip implant with its proprietary Kinectiv Technology. This model of the M/L Taper with the Kinectiv technology utilized a modular MoM design that featured a cobalt-chromium coupling. In court documents, claimants allege that the Zimmer hip joint suffers from corrosion which introduces metal fragments into surrounding tissue as well as elevated levels of metals into the bloodstream causing pain, swelling, tissue necrosis, and other ailments.

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Sources Cited (20)

1) “Hip Revision” https://my.clevelandclinic.org/health/treatments/17104-hip-revision

2) “How Long Does It Take to Recover from Hip Replacement Surgery” https://www.thedacare.org/News-and-Events/Symptoms-and-Conditions/How-Long-Does-it-Take-to-Recover-from-Hip-Replacement-Surgery.aspx

3) “About Hip Revision Surgery” https://www.cedars-sinai.org/health-library/diseases-and-conditions/r/revision-hip-surgery.html

4) “Osteolysis” https://www.hss.edu/condition-list_osteolysis.asp

5) “Revision Total Hip Replacement: An Overview” https://www.hss.edu/conditions_revision-total-hip-replacement-overview.asp

6) “Revision surgery of metal-on-metal hip arthroplasties for adverse reactions to metal debris” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6055775/

7) “When to Have Hip Revision Surgery Due to Metal-on-Metal Prostheses” https://holycrossleonecenter.com/when-to-have-hip-revision-surgery-due-to-metal-on-metal-prostheses/

8) “REVISION HIP REPLACEMENT” https://www.stefankreuzermd.com/revision-hip-replacement.html

9) “Preventing Blood Clots After Hip or Knee Replacement Surgery or Surgery for a Broken Hip” https://www.ncbi.nlm.nih.gov/books/NBK107165/#:~:text=DVT%20is%20the%20most%20common,or%20weeks%20after%20the%20surgery.

10) “PREVENTION AND TREATMENT OF BLOOD CLOTS AFTER HIP AND KNEE REPLACEMENT SURGERY” https://www.stoptheclot.org/about-clots/toolkit-for-knee-hip-replacement-patients/prevention-and-treatment-of-blood-clots-after-hip-and-knee-replacement-surgery/

11) “Deep Vein Thrombosis” http://www.ucihealth.org/medical-services/orthopaedics/hip-knee-surgery-services/deep-vein-thrombosis

12) “BLOOD CLOTS IN ORTHOPEDIC SURGERY FACT SHEET” https://www.stoptheclot.org/about-clots/toolkit-for-knee-hip-replacement-patients/orthopedic-surgery-fact-sheet/

13) “Blood Clots After Surgery” https://www.webmd.com/dvt/blood-clots-after-surgery

14) “Hip Dislocation” https://www.hss.edu/condition-list_hip-dislocation.asp

15) “Dislocation Following Total Hip Replacement” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4298240/

16) “Risk factors for dislocation after primary total hip replacement: a systematic review and meta-analysis of 125 studies involving approximately five million hip replacements” https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30045-1/fulltext

17) “Hip replacement” https://www.mayoclinic.org/tests-procedures/hip-replacement/about/pac-20385042

18) “Total Hip Replacement Fundamentals” https://my.clevelandclinic.org/health/treatments/17102-hip-replacement

19) “Signs & Symptoms” https://www.sahortho.com/joint/signs-symptoms#:~:text=Thigh%20or%20groin%20pain%20is,a%20sign%20of%20implant%20loosening.

20) “Hip Replacement Loosening Symptoms” https://www.verywellhealth.com/hip-replacement-loosening-2548623#:~:text=The%20most%20common%20cause%20of,This%20problem%20is%20called%20osteolysis.

Last Updated November 23, 2020

A hernia is a condition where an organ, intestine, or fatty tissue (typically in the abdomen) pushes through a weak spot in a surrounding muscle or connective tissue. They are usually caused by a combination of pressure and the development of the weak spot. Hernias are more common later in life – although they can manifest at birth. Factors contributing toward hernia development are obesity; lifting heavy objects; diarrhea or constipation; or persistent coughing/sneezing. Additionally, poor nutrition, smoking, and overexertion can contribute to the formation of a hernia.

The only way to repair a hernia is with surgery.  Hernia surgery is one of the most common surgical procedures performed worldwide.  The most straightforward method is for a surgeon to make an open incision into the abdomen and then attempt to repair the breach in the tissue wall with sutures.  However, this type of procedure has a high rate of “recurrence” meaning that the sutures do not hold up well over time and further procedures become necessary.

As an alternative to sutures, surgeons prefer to use mesh devices as a tool to strengthen the area around hernias and make a repair that has less possibility of recurrence. Historically, surgical mesh has been used to repair hernias for well over a century in the United States. Today, more than 80% of hernia repair procedures performed in the U.S. involve mesh and there are more than 70 types of mesh commercially available.

Hernia Surgical Mesh Treatment Options

The most common type of hernia repairs involve inguinal hernias. Other types of repair procedures can involve the following types of hernias:

• Femoral
• Inciscional
• Ventral
• Umbilical
• Hiatal

For some types of hernias, surgeons may elect to take a “wait-and-see” approach if the patient is not experiencing any serious complications. Instead, they will opt, with the patient, to monitor the hernia to ensure it is not getting any larger or causing other issues.

When surgery is a necessity, doctors will opt for one of two incision protocols based upon the patient’s condition and needs. The choice of the incision will also inform their choice of mesh device.

• Laparoscopic: This involves the surgeon making a small incision in the abdomen which will allow for surgical tools to be inserted to effect hernia repair. Not all mesh devices are well-suited for this type of procedure.
• Open Repair Surgery: This is a more traditional incision near the hernia for the purpose of repairing weak muscle tissue. If sutures are used instead of mesh, the procedure is referred to as a “primary closure”

Among laparoscopic incisional procedures, surgeons will choose a repair “approach” to effectuate repair. The most common approaches involve the position of the hernia relative to the peritoneum – the tissue lining your abdominal wall. Accordingly, these approaches are referenced as:

• Transabdominal Preperitoneal (TAPP): The surgeon will go into the peritoneal cavity to place a mesh device over possible hernia sites.
• Totally Extraperitoneal (TEP): The surgeon will not enter the peritoneal cavity and mesh will be used to seal a hernia from outside of the peritoneum. 
• Intraperitoneal Onlay Mesh Technique (IPOM): Introduced in the early 1990s, IPOM involves a small incision where gas is blown into the abdomen to get better visibility for the surgeon.  Once surgical tools are inserted through the incision, surgeons can place and suture a hernia mesh directly onto the peritoneum where it can come into contact with the intestines or other abdominal organs.

Types of Hernia Mesh

Surgical hernia mesh is typically constructed either from animal tissue or entirely man-made (“synthetic”) materials. Synthetic mesh, such as those made from polypropylene, are made into “knitted” or “non-knitted” sheet formats. Furthermore, they can be “absorbable” or “non-absorbable” materials – or even a combination of the two. The animal-derived mesh is usually considered to be absorbable and will degrade over time while promoting new tissue growth to strengthen the hernia repair. Consequently, the absorbable mesh is not generally regarded as a long-term repair solution.

Potential Issues and Complications with Hernia Mesh

Most new mesh brands, in particular the synthetic ones, were “fast-tracked” for review by the U.S. Food and Drug Administration (FDA) through its abbreviated 510(k) clearance process which does not require stringent testing or clinical trials prior to implantation. In post-market surveillance, some common mesh brands have been associated with the following issues in patients:

• Migration: Movement of the hernia mesh within the body.
• Contraction: The mesh will collapse on itself and no longer cover the hernia location.
• Adhesion: Scar-like tissue creation that can cause the tissue to “stick” or bind together.
• Fistula: Leakage into body cavities or through the skin due to an abnormal connection between the organs or intestines.
• Perforation: A hole or the bowels or neighboring organs due to contact irritation or an abrasion from the mesh.

Some mesh devices have been the subject of recalls and litigation. If you were implanted with a hernia mesh product and you are now experiencing pain and/or having to undergo invasive revision or removal surgery, you may be interested to explore your options for receiving compensation for suffering and medical expenses.

Last Updated November 10, 2020

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:

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.

Last Updated October 27, 2020

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.

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2. “DailyMed: Nuvigil – Armodafinil” https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d878aed0-ddbf-8fa1-abf7-d3e480260845

3. “State of California v. Teva Pharmaceuticals, et al.” https://oag.ca.gov/sites/all/files/agweb/pdfs/antitrust/provigilsettlement/complaint.pdf

4. “Taking Provigil While Pregnant: What You Need to Know” https://www.therecoveryvillage.com/provigil-addiction/provigil-while-pregnant/

5. “Facts about Cleft Lip and Cleft Palate” https://www.cdc.gov/ncbddd/birthdefects/cleftlip.html

6. “Facts about Hypospadias” https://www.cdc.gov/ncbddd/birthdefects/hypospadias.html

7. “Facts about Microcephaly” https://www.cdc.gov/ncbddd/birthdefects/microcephaly.html

8. “The Safety of Stimulant Medication Use in Cardiovascular and Arrhythmia Patients” https://www.acc.org/latest-in-cardiology/articles/2015/04/28/10/06/the-safety-of-stimulant-medication-use-in-cardiovascular-and-arrhythmia-patients

9. “First-Trimester Pregnancy Exposure to Modafinil and Risk of Congenital Malformations” https://jamanetwork.com/journals/jama/fullarticle/2759460

10. “What are Congenital Heart Defects?” https://www.cdc.gov/ncbddd/heartdefects/facts.html

11. “Modafinil: Potential Risk of Congenital Malformations When Administered During Pregnancy” http://www.hpra.ie/docs/default-source/default-document-library/important-safety-information—modafinil99170c2697826eee9b55ff00008c97d0.pdf

12. “Practical Use and Risk of Modafinil, a Novel Waking Drug” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3286657/

13. “Health Canada Warns that Modafinil May Cause Fetal Harm” https://aasm.org/health-canada-warns-modafinil-fetal-harm/

14. “FDA Pregnancy Categories” https://chemm.nlm.nih.gov/pregnancycategories.htm

15. “Armodafinil While Pregnant: What You Need to Know” https://www.therecoveryvillage.com/armodafinil-addiction/armodafinil-while-pregnant/#gref

16. “Mechanisms of Modafinil: A Review of Current Research” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2654794/

Last Updated November 14, 2020

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.

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Sources Cited (23)

1) “Past, Present and Future of Surgical Meshes: A Review” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5618132/

2) “A History of Polypropylene Hernia Mesh and Its Many Problems” https://herniamesh.legalexaminer.com/technology/medical-devices-implants-technology/a-history-of-polypropylene-hernia-mesh-and-its-many-problems/

3) “Everything You Need To Know About Polypropylene (PP) Plastic” https://www.creativemechanisms.com/blog/all-about-polypropylene-pp-plastic

4) “Suture versus preperitoneal polypropylene mesh for elective umbilical hernia repairs” https://pubmed.ncbi.nlm.nih.gov/24980854/

5) “Current Issues and Challenges in Polypropylene Foaming: A Review” https://www.researchgate.net/publication/282672632_Current_Issues_and_Challenges_in_Polypropylene_Foaming_A_Review

6) “RECENT PROBLEMS AND FAILURES WITH PP MESH IMPLANTS HAVE LED TO THOUSANDS OF HERNIA AND SURGICAL MESH LAWSUITS” https://www.plasticexpert.com/plastic-technology/are-polypropylene-mesh-implants-safe/

7) “Surgical approach to abdominal wall defects: history and new trends” https://www.sciencedirect.com/science/article/pii/S1743919113600084

8) “Mesh infection in cases of polypropylene mesh hernioplasty” https://pubmed.ncbi.nlm.nih.gov/32096086/

9) “Complications of polypropylene mesh for the treatment of female pelvic floor disorders” https://pubmed.ncbi.nlm.nih.gov/21965260/

10) “Biologic versus Synthetic Mesh Reinforcement: What are the Pros and Cons?” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4477030/

11) “Polypropylene mesh implantation for hernia repair causes myeloid cell–driven persistent inflammation” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6413778/

12) “Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3424888/

13) “Urogynecologic Surgical Mesh Implants” https://www.fda.gov/medical-devices/implants-and-prosthetics/urogynecologic-surgical-mesh-implants

14) “Polypropylene mesh implantation for hernia repair causes myeloid cell–driven persistent inflammation” https://insight.jci.org/articles/view/123862

15) “Recurrent urinary tract infection due to hernia mesh erosion into the bladder” https://www.researchgate.net/publication/7970758_Recurrent_urinary_tract_infection_due_to_hernia_mesh_erosion_into_the_bladder

16) “Surgical Mesh: Use and Complications in Women” https://my.clevelandclinic.org/health/articles/16298-surgical-mesh-use-and-complications-in-women

17) “Polypropylene mesh and systemic side effects in inguinal hernia repair: current evidence” https://pubmed.ncbi.nlm.nih.gov/30915679/

18) “Life after mesh: One patient’s harrowing experience with transvaginal mesh” https://www1.racgp.org.au/newsgp/clinical/life-after-mesh-one-patient-s-harrowing-experience

19) “Mesh Information for Patients – Frequently Asked Questions (FAQs)” https://centralcarolinasurgery.com/posts/news/mesh-information-for-patients-frequently-asked-questions-faqs/

20) “Mesh materials and hernia repair” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5571666/

21) “Late-onset Deep Mesh Infection: A Study of Eight Cases Detected from 2666 Consecutive Patients with Abdominal Wall Hernia Repairs” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4976579/

22) “The Many Types of Hernia Mesh Explained” https://michiganherniasurgery.com/posts/hernia-repair/the-many-types-of-hernia-mesh-explained/

23) “Hernia Surgical Mesh Implants: FDA Activities” https://www.fda.gov/medical-devices/hernia-surgical-mesh-implants/hernia-surgical-mesh-implants-fda-activities

Last Updated November 16, 2020

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.

Updated December 17, 2020

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:

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.  

Last Updated November 7, 2020

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.

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Sources Cited (16)

1) “How to Quit Vaping” https://teen.smokefree.gov/quit-vaping/how-to-quit-vaping

2) “Ready to Ditch Vaping? 9 Tips for Success” https://www.healthline.com/health/how-to-quit-vaping

3) “Quitting vaping? Here are 5 tips for handling nicotine withdrawal” https://truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-vaping-here-are-5-tips-handling-nicotine

4) “6 Steps to Quit Vaping or Smoking” https://www.psychologytoday.com/us/blog/working-through-shame/201906/6-steps-quit-vaping-or-smoking

5) “Vaping Addiction and Nicotine Withdrawal” https://teen.smokefree.gov/quit-vaping/vaping-addiction-nicotine-withdrawal#:~:text=Nicotine%20is%20in%20most%20vapes,help%20manage%20your%20withdrawal%20symptoms.

6) “5 Vaping Facts You Need to Know” https://www.hopkinsmedicine.org/health/wellness-and-prevention/5-truths-you-need-to-know-about-vaping

7) “Adult Smoking Cessation—The Use of E-Cigarettes” https://www.cdc.gov/tobacco/data_statistics/sgr/2020-smoking-cessation/fact-sheets/adult-smoking-cessation-e-cigarettes-use/index.html

8) “Electronic Cigarettes” https://www.cdc.gov/tobacco/basic_information/e-cigarettes/index.htm

9) “Quit Smoking” https://www.cdc.gov/tobacco/quit_smoking/index.htm

10) “Vaping Illness Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street” https://www.fda.gov/consumers/consumer-updates/vaping-illness-update-fda-warns-public-stop-using-tetrahydrocannabinol-thc-containing-vaping

11) “Want to Quit Smoking? FDA-Approved Products Can Help” https://www.fda.gov/consumers/consumer-updates/want-quit-smoking-fda-approved-products-can-help

12) “ELIMINATING YOUTH ELECTRONIC CIGARETTE AND OTHER TOBACCO PRODUCT USE: THE ROLE FOR DRUG THERAPIES” https://www.fda.gov/media/120342/download

13) “E-Cigarettes are More Addictive than Traditional Cigarettes—A Study in Highly Educated Young People” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6651627/#:~:text=The%20nicotine%20dependence%20levels%20measured,1.6%3B%20p%20%3C%200.001).

14) “Nicotine Addiction From Vaping Is a Bigger Problem Than Teens Realize” https://www.yalemedicine.org/stories/vaping-nicotine-addiction/

15) “Four E-cigarette Health Risks for Kids” https://www.nm.org/healthbeat/healthy-tips/emotional-health/vaping-4-risks-for-kids

16) “How Hard Is It to Quit Vaping?” https://elemental.medium.com/how-hard-is-it-to-quit-vaping-c58cf754d913

Last Updated November 9, 2020

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

Last Updated October 26, 2020

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