Paragard IUD MDL Created in North District of Georgia

Paragard IUD MDL Created in North District of Georgia

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It’s an emerging tort that has potential to amass a number of cases.

Paragard is an IUD (intrauterine device) used to prevent pregnancy. It was approved by the U.S. Food and Drug Administration (FDA) in 1984.

Paragard is owned by Cooper Surgical, maker of surgical and laparoscopic instruments primarily for women’s surgical needs including devices for hysterectomy, pelvic surgery, and C-section procedures.

Because of the large number of reported complications, multidistrict litigation has recently formed in the North District of Georgia. Currently there are 95 cases filed.

Adverse events reported include the device breakage during explant (removal) surgery causing complications and injuries and the need for follow-up surgery to remove the pieces, infertility, and pain.

Other complications include:

  • Organ perforation
  • IUD arms embed in uterine wall
  • Migration outside of the uterus
  • Pieces difficult to locate
  • Ectopic pregnancy
  • Possible hysterectomy

Copper IUD

IUDs are an increasingly popular form of birth control. There are two types – hormonal and copper.

Paragard is a copper contraceptive that is advertised as “100% hormone free.” Made of flexible polyethylene plastic wrapped with a thin layer of copper coil around the arms and stem, Paragard blocks the sperm from reaching an egg and may also prevent implantation. The copper is emitted and incites an inflammatory reaction toxic to sperm and egg.

Paragard is the only copper emitting IUD used in the U.S. Three other IUDs on the market emit hormones – Mirena, Skyla and Liletta.

About the size of a pack of sugar, the user is not expected to feel Paragard. Periods are expected to be heavier and longer with spotting in between. Pregnancy with an IUD in place is associated with an increased risk of miscarriage, premature labor and delivery, and sepsis. There is even a 27% rate of miscarriage when the IUD is removed from a pregnant woman.

Long-term studies on animals to assess the potential of cancer with a copper-containing IUD have not been performed.

 

FDA and Paragard

The FDA has warned that Paragard removal may be difficult because of “partial penetration or embedment of Paragard in the myometrium” (middle layer of the uterine wall).

Since it was approved, the FDA has received more than 40,000 reports of complications associated with Paragard including 15 deaths, however, Paragard remains on the market.

In an FDA letter to CooperSurgical Regulatory Affairs, dated July 2019, the agency warns the direct-to-consumer (DTC) advertising with the dancing Paragard users, makes false or misleading representations about the risks associated with Paragard.

IUDs have long been associated with an increase in pelvic inflammatory disease (PID), infertility and death.

The use of an IUD as a reliable form of birth control has been around for decades but IUDs gained a bad reputation from the complications associated with use of the Dalkon Shield of the 1970s. Hundreds of thousands of women reported problems with pelvic inflammatory disease, infertility, spontaneous abortions, and death.  The Dalkon Shield incident encouraged the passage of the Medical Device Amendments of 1976, that, for the first time, gave the FDA some control over medical devices.

In another case of IUD complications, Bayer offered a $12.2 million settlement in 2018 to thousands of claimants over complications associated with Mirena IUD.


ParaGard MDL

On December 16, 2020, the Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order creating the Paragard MDL. So far, 95 cases have been filed in MDL 2974 in the Northern District of Georgia before U.S. District Judge Leigh Martin May. At the time, there were 80 actions pending in 36 districts.

The defective product action will include manufacturing defect, defective design, marketing, promotion, labeling, packaging, and distribution, and a failure-to-warn, gross negligence, and consumer protection law fraud. The plaintiffs seek punitive damages.

The defendants are alleged to have understood the risks from clinical trials and post-marketing complaints but failed to warn and instead concealed and suppressed the dangers, one complaint reads. (Plendl v Teva et al)

CooperSurgical opposed the centralization of cases but the JPLM rejected claims that the creation of an MDL would generate the filing of voluminous claims without due diligence by lawyers for the plaintiffs. Instead, it found the Northern District of Georgia serviced the convenience of the parties involved.  Six of the actions were already filed in the Northern District of Georgia. None of the cases has been resolved.

The new drug application (NDA) for Paragard was previously held by Teva Women’s Health, Inc. from November 10, 1995 to August 11, 2017. Most of the actions filed so far name Teva Pharmaceuticals USA, Inc. et al.

Previously, Duramed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals Inc. DBA Teva Women’s Health Inc., acquired FEI (Finishing Enterprises Inc.) Women’s Health in 2005. The deal included the Paragard IUD.

Duramed was acquired by Teva USA in 2008. Cooper Companies, a Delaware Corporation with headquarters in Pleasanton, California, purchased assets of Paragard IUD in September 2017 for $1.1 billion. CooperSurgical is a subsidiary of Cooper Companies. Under Georgia law, successors-in-interest are liable.

 

Sources:

Pending mdl  https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-January-15-2021.pdf

FDA letter
https://www.fda.gov/media/129526/download

Hand Sanitizer from Mexico on Import Alert

Hand Sanitizer from Mexico on Import Alert

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The warning was issued in January from the U.S. Food and Drug Administration (FDA). More than half of the alcohol-based hand sanitizers sent to the U.S. from Mexico contain dangerous ingredients toxic to Americans. The FDA has now placed all hand sanitizers labeled as alcohol-based and made in Mexico on a countrywide “import alert.”

Young children may have been the unintended victims of more than 900 accidental poisonings which have been reported to poison control centers around the country.

The agency recalled 75 brands of hand sanitizers contaminated with methanol, or wood alcohol. When ingested through the skin, methanol can be toxic and life-threatening when ingested.

Other complications include:

  • Nausea
  • Blindness
  • Vomiting
  • Headaches
  • Blurred vision
  • Seizures
  • Drowsiness
  • Confusion
  • Heart failure

Hospitalizations and deaths have resulted. It can take up to three days before the adverse health events are apparent.

Hand sanitizers are used when there is not a readily available source of soap and water to remove any exposure to the COVID-19 virus. The Centers for Disease Control and Prevention (CDC) recommends using an alcohol-based hand sanitizer with at least 60 percent ethanol, which may also appear on the label as ethyl alcohol (not methyl alcohol) or 70 percent isopropyl alcohol.

 FDA Action Regarding Hand Sanitizers From Mexico

An FDA review of all hand sanitizers from Mexico from April through December 2020 revealed 84 percent of the samples were out of compliance, with more than half containing either methanol or 1-propanol at dangerous levels. Methanol is not a listed ingredient.

Instead, the labels say the product contains ethanol. Some of the labels say “FDA-approved” even though there is no hand sanitizer that has FDA approval.

FDA has been working with the retailers to recall products and remove them from store shelves.

The FDA has issued 14 warning letters to manufacturers for the misleading labels and claims. The first consumer alert letter went out in June 2020 for nine hand sanitizers made in Mexico. From May to June, 15 adults were hospitalized after ingesting the tainted products.

Some people reportedly drink hand sanitizer to get an alcohol high. Others believe ingesting hand sanitizer can disinfect the body internally. Four have died and three suffered vision impairment.

Ironically, it was the FDA that issued a call for more companies to produce over-the-counter (OTC) hand sanitizers when COVID-19 hit the country in early 2020. Looking to cash in, many manufacturers began to manufacture the product. The FDA then relaxed some regulatory requirements for these new products.

The agency then reportedly swung the other way and supplies of hand sanitizer were detained at the border as the FDA required records demanding the hand sanitizer was in compliance with Good Manufacturing Practice requirements. Some law firms are calling that too heavy handed.

 Hand Sanitizer Recalls

The FDA has now expanded its recall to more than 200 different hand sanitizers allegedly containing wood alcohol. While Mexico is the main manufacturer, others are made in Guatemala, Turkey, Korea, China and six states in the U.S.

Of the 20 or more recent deaths associated with hand sanitizers, 16 involving methanol poisoning.  Seven of those cases were linked directly to Mexican-made hand sanitizer.

Costco, Walmart, and CVS all sold the hand sanitizers. The FDA has not revealed to CBS News how many of the poisonous products were sold.

Data from the National Poison Data System in January shows there were 938 hand sanitizer exposure cases in ten days in January that were reported to 55 U.S. Poison Control Centers.  That is a 57% increase from one year ago. Almost 600 cases involved young children under the age of 5.

Nationwide, 1,585 exposed to methanol were reported from May to August 2020, reports the American Association of Poison Control Centers.

It is a problem globally as well. Due to the popular myth that drinking hand sanitizer might clear you internally of the virus, about 800 people have died from drinking methanol, 5,900 have been hospitalized and 60 became blind, primarily in Turkey, Qatar, India, and Iran.

Recalled Brands of Hand Sanitizers

Among the 53 different Mexican manufacturers named in the recall are:

  • Yacana Hand Sanitizer, 70% Alcohol.
  • Blumen Advanced Instant Hand Sanitizer
  • Klar and Danver Instant Hand Sanitizer
  • Modesta Instant Hand Sanitizer
  • Eskbiochem Hand Sanitizer
  • The Honeykeeper Hand Sanitizer
  • Hello Kitty Hand Sanitizer
  • Assured Instant Hand Sanitizers
  • Bio aaa Hand Sanitizer
  • LumiSkin Advance Hand Sanitizer
  • QualitaMed Hand Sanitizer
  • NEXT Hand Sanitizer
  • NuuxSan Instant Antibacterial Hand Sanitizer
  • Modesa Instant Antiseptic Hand Sanitizer
  • Argent Defense Group
  • Dolphin Hands Sanitizer
  • V-Klean Hand Sanitizer
  • Medically Minded
  • Protz Real Protection
  • Alcohol Antiseptic

Consumers can check the “do-not-use” list at www.fda.gov/handsanitizerlist.

If someone ingests methanol, the antidote is an IV medicine called fomepizole which makes methanol less toxic to the body. It’s important to seek medical treatment immediately if this has happened to you or someone close to you.

 

Sources:

FDA
https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use?ftag=MSFd61514f

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-place-all-alcohol-based-hand-sanitizers-mexico-import

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/grupo-yacana-mexico-sas-de-cv-609824-01262021
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/grupo-yacana-mexico-sas-de-cv-issues-voluntary-nationwide-recall-all-lots-yacana-hand-sanitizer-due

https://www.accessdata.fda.gov/CMS_IA/importalert_1171.html

CBS
https://www.msn.com/en-us/news/us/hundreds-of-americans-poisoned-by-hand-sanitizer-this-month/ar-BB1d93RH

Natl Law Review
https://www.natlawreview.com/article/fda-places-all-alcohol-based-hand-sanitizers-mexico-import-alert

Morbidity and Mortality Weekly Report, August 14 2020

Upcoming Hernia Mesh Trials Ahead Name 3 Makers in 15,000 cases

Upcoming Hernia Mesh Trials Ahead Name 3 Makers in 15,000 cases

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If the upcoming hernia mesh product liability trials are any indication, they could exceed the 100-thousand pelvic mesh cases amassed in West Virginia multidistrict litigation (MDL).

Thousands of litigants claim that an implanted polypropylene hernia mesh injured them severely. So far, there are three MDLs that have formed and since the COVID-19 court shutdown litigants had to be patient in 2020. With the new year, that may change.

Bellwether trials are being scheduled for the three mesh makers.

Ethicon, a division of Johnson & Johnson, Atrium Medical, and C.R. Bard/Davol are facing 15,000 cases filed by plaintiffs who claim defective design of the hernia mesh. With more than one million hernia meshes implanted in the U.S. every year, the potential numbers of litigants may ultimately exceed the pelvic mesh litigation.

Ethicon makes its hernia mesh from the same polypropylene (PP) that is used in pelvic mesh. It tends to shrink, erode, migrate, and become infected once implanted. Nerve damage is also reported as is sepsis and fatalities.

Ethicon’s PHYSIOMESH™ MDL 2782 is located in the Northern District of Georgia, Atlanta Division, MDL 2782 (1:17-md-02782-RWS).

So far, there are 3,334 cases filed there. The first trial is set for January 25, 2021 before Judge Richard Story.

Ethicon’s PHYSIOMESH™ is a flexible composite mesh coated with DS (Polydioxanone) film. The unique design was supposed to minimize adhesions and inflammation while facilitating incorporation of the mesh into the abdomen. Instead, plaintiffs argue that the layers coating the polypropylene prevented adequate incorporation of the mesh into the body and weakened the strength of the mesh. Physiomesh was taken off the market by Johnson & Johnson in May 2016.

Plaintiff Jim Crumbley had Physiomesh implanted which failed. He alleges defective design and manufacturing, failure to warn, negligence and a violation of Georgia’s consumer protection laws.

Atrium Medical

Atrium’s C-Qur hernia mesh lawsuits numbered 2,378 as of October and are consolidated in an MDL in New Hampshire before Judge Landya B. McCafferty in Concord (MDL 2753). Currently there are 2,477 with 2,433 unresolved. Carrie Barron is the lead plaintiff in this MDL with her trial set for January 20, 2021. Followed by Martha Luna. Case No.16-md-2753-LM.

Atrium is headquartered in Merrimack, New Hampshire.

Like Physiomesh, C-Qur is a polypropylene mesh coated with three fatty acids made of highly purified pharmaceutical grade fish oil. The presence of the oil allegedly presents a high rate of infection and rejection, organ perforation, inflammation, and encapsulation of the mesh with scar tissue which results in pain. Patients implanted with C-Qur have complained of adhesions of the mesh to the bowel, rashes, poor memory, and chronic dental problems.

C-Qur was recalled by the FDA in 2013 after a number of adverse events were reported to the agency. The hernia mesh was not removed from the shelves of hospitals or doctor’s offices. Atrium simply wrote a letter notifying doctors to be aware the mesh coating could stick to the packaging.

C.R. Bard/ Davol & Ventralight ST Hernia Mesh

Plaintiff, Steven Johns is the first case that will go to trial April 19, 2021 in the Bard MDL (2846) based in the Southern District of Ohio. Columbus Ohio.  (Case 2:18-md-2846).

The New Jersey-based company is facing more than 8,000 product liability claims naming Bard’s Ventralex, Perfix, 3DMax.

In September, U.S. District Judge Edmund A. Sargus denied the manufacturer’s motion for summary judgment. Judge Sargus ruled the defense experts cannot say the mesh “is in no way defective,” or that the warnings about the risk are sufficient.

The judge issued a pre-trial order that the jury may award punitive damages to those who have been severely injured by the defective Bard Ventralight ST hernia mesh medical device. Failure to warn is party of the case against the defendant and Johns’ doctor said if he had been fully informed by Bad Davol he would not have used this mesh on the plaintiff.

Steven Johns v. C.R Bard, et al. (Case No. 2:18-cv-01509-EAS-KAJ), alleges he faces pain, hernia recurrence, and adhesions. Johns had surgery to remove the mesh and replace it with a new Ventralight ST.

West Virginia Product Liability Laws

West Virginia Product Liability Laws

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Roughly 30,000 new products hit the American market every year, and the vast majority of those products never cause injury or illness. However, those that do tend to leave significant destruction in their wake. Products that are marketed irresponsibly, designed poorly, or otherwise unsafe can leave victims with tens of thousands of dollars in medical bills and other expenses.

If you or someone you love has been injured by a defective or dangerous product in West Virginia, it’s time to talk to an attorney and find out what your legal options are.

Types of Defects

A faulty product may be considered defective for a variety of reasons. While many people assume that fault always comes back to the company selling the product, liability can actually fall on any party involved in the design, creation, marketing, or distribution of the product.

The main types of product defects include:

  • Design defects. When the design of something is inherently flawed in a way that makes it unsafe to use, liability falls on the party responsible for designing the product. In this type of claim, the product was manufactured to the specifications given, but the specifications given were flawed.
  • Manufacturing defects. In this situation, the product was designed in a way that would make it safe and effective for the intended market. However, during the manufacturing of the product, errors occurred. Perhaps the company responsible for manufacturing did not perform proper maintenance on their machinery, used subpar materials, or skipped steps in the manufacturing process.
  • Marketing defects. Products are designed with a target market in mind and created for a specific use. If marketing paints products in a different light by recommending them to groups for whom the product is unsafe or recommends using products in a way that they should not be used, the marketing firm could be liable for victims’ losses.

Different Types of Liability Theories

Depending on the circumstances of your injury and the product that caused it, your lawyer may explore different theories of liability to determine which is best suited to your case. The main three theories used in these cases are:

  • When designing, creating, and marketing products, companies are expected to use a reasonable amount of caution to ensure that they are not putting consumers in harm’s way. If they fail to meet this standard and cause injuries, they may be liable for the damage caused.
  • Breach of warranty. Many products come with express or implied warranties. When companies fail to follow through on the terms of their warranties and someone is injured because of it, they may be held responsible for the consumer’s financial losses.
  • Strict liability. In some cases, it is nearly impossible to prove that a product caused an illness or injury. However, this does not mean that the product did not cause illness or injury. Under strict liability, a company involved in the design, creation, or marketing of a product may be held liable even if it cannot be proven that they were negligent.

Damages for a West Virginia Product Liability Claim

When you are injured because of a defective product, you can seek compensation for your losses. What you actually get is dependent on the details of your case, how competent and aggressive your attorney is, and how much pushback you get from the liable party. Some of the compensation you may ask for includes:

  • Medical bills, current and future. Medical bills are a leading cause of bankruptcy in the United States, so if someone else is liable for your injuries it is only fair that they also cover your medical expenses. Generally, this only includes medical costs you have already incurred. However, if your injury is serious enough to require ongoing or long-term care, you may also seek compensation for future medical expenses.
  • Lost wages and future loss of income. Taking time off work can be financially devastating, especially considering that most Americans live paycheck to paycheck. Whether you have to take a few days off of work to get treated for your injuries or you spend months away from work trying to heal, you deserve compensation for your lost wages. You may be awarded additional compensation if your ability to work is permanently affected.
  • If an injury leads you with permanent disability, you should receive compensation for the expenses that come with this significant change. You may need money to rework your home for disability access, purchase adaptive equipment, and pursue occupational therapy to learn how to live with your limitations.
  • Property damage. Some defective products cause property damage. Consider, for an example, a defective microwave that explodes and destroys your kitchen. These losses should also be compensated.
  • Pain and suffering. Not every loss comes with a clear financial cost. That doesn’t mean that those losses shouldn’t be compensated. Pain and suffering, mental anguish, loss of enjoyment of life, and other non-financial losses are still compensable.
  • Punitive damages. If your case goes to court, you may be awarded punitive damages. Courts award punitive damages not to make the victim whole, but to punish the liable party and discourage similar behavior in the future. In a product liability case, this may be done if the company knew about the defects beforehand but chose to go to market anyway.

Why You Need a West Virginia Product Liability Attorney

The field of product liability law is complex, and without an attorney to help you with your claim, it’s unlikely you’ll get far in your quest for compensation. There are multiple legal theories that may be applicable to your case and you’ll need to meet a substantial burden of proof to get compensation.

An attorney can take this weight off your shoulders and allow you to focus on healing from your injuries. Through their investigation, they will figure out which party is liable for your injuries, how the product directly led to your injuries, and what it will take for you to receive fair compensation.

From there, they will move on to negotiations. Companies spend a substantial amount of money on their legal teams, so you want an attorney who is aggressive and willing to stand up to corporate lawyers. A seasoned attorney will build a solid case that proves why you deserve compensation and fight back against the other side’s efforts to discredit your injuries. And if your case goes to court, they will be ready to fight for every penny you deserve.

Contact a West Virginia Product Liability Lawyer Today

Defective products cause untold amounts of damage every year, but you don’t have to fight the company alone. With the help of an experienced product liability attorney, you can pursue just compensation for your injuries. Get in touch with an attorney today to help you with your case.

Elmiron Bladder Pain Drug Warning Added by J&J

Elmiron Bladder Pain Drug Warning Added by J&J

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Made by Janssen Pharmaceuticals, a division of Johnson & Johnson, Elmiron (pentosan polysulfate sodium), was approved by the U.S. Food and Drug Administration (FDA) to protect the bladder wall from irritants in urine, which causes interstitial cystitis or painful bladder syndrome.

Elmiron actually works like heparin and is a weak anticoagulant, acting like a blood thinner.

It is not a cure, but Elmiron promised to provide some relief to the painful symptoms for the three to eight million women affected from the pain associated with the inflammation or irritation of the bladder. It’s estimated up to four million men may also suffer from interstitial cystitis, which may be due to a defect in the protective lining of the bladder.

Symptoms include a burning sensation and urinary urgency, a feeling of discomfort of pressure in the bladder or lower abdomen, pain during intercourse, and pelvic floor muscle pain.

Now, 24 years after its approval, Elmiron is linked to maculopathy, the most common cause of blindness.

Janssen Pharmaceuticals, a division of Johnson & Johnson, added a warning in June concerning a potential life-altering retinal disorder – pigmentary maculopathy. This was added to the side effects already appearing on the instructions for use (IFU) including abnormal liver function, nausea, diarrhea, and hair loss.

Sufferers usually experience vision loss after at least two years. The vision problems must have onset within a year of stopping the drug or during its use. Damage may stop if caught in the early stages of drug use.

Scientific Studies

Three ophthalmologists conducting a review of patients at Kaiser Permanente in Northern California found about one-quarter of users of Elmiron displayed signs of eye damage. Taking a closer look at 91 patients who had taken an average of 5,000 pills found 22 patients with signs of drug toxicity.

Emory Eye Center in Atlanta, Georgia also noted six patients who were long-term users of Elmiron developed changes to their macula, the part of the eye which allows us to see with detail and clarity.

Lawsuits alleging a failure to warn the public and doctors about the risk of vision problems are now being filed. Tens of thousands of patients may be affected.  Patients who have filed report they are experiencing blurred vision and vision impairment including retinopathy and maculopathy.

Patients with liver issues should consult with their doctor before using the drug.

WARNINGS

Retinal Pigmentary Changes

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor. Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.”

Symptoms of Elmiron use may include:

* Dimming vision

* Difficulty reading

* Difficulty adjusting to the light

* Loss in a field of vision

* Loss of night vision

* Difficulty seeing objects that are close

* Blindness

* Halo vision

* a diagnosis of pigmentary maculopathy

*A diagnosis of macular degeneration

* A diagnosis of Macular Retinopathy

* A diagnosis of Retinal Deterioration

* A diagnosis of Pattern dystrophy

LEARN MORE:

American Academy of Ophthalmology news release

FDA Prescribing Information for Elmiron

May 2018, Pigmentary Maculopathy Associated with Chronic Exposure to Pentosan Polysulfate Sodium

Multi-District Litigation Formed for Allergan’s Textured Breast Implants

Multi-District Litigation Formed for Allergan’s Textured Breast Implants

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Litigation is proceeding in New Jersey federal court concerning Allergan’s Biocell Textured Breast Implants. The multidistrict litigation (MDL 2921) was formed in December before The Honorable Judge Brian R. Martinotti and Judge Joseph Dickson.

Back in 2017 and earlier in 2011, the FDA warned about a rare form of cancer – anaplastic large-cell lymphoma, a cancer in the lymphatic system.  This rare form of Non-Hodgkin’s lymphoma can develop after a breast implant procedure, specifically textured breast implants, according to the FDA.

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) may be the result of the texture on the implant, created to keep it in place. The increased surface caused by the texturing may retain more bacteria than a smooth implant. One theory is that biofilms form creating chronic inflammation.

So far, 393 defective product complaints have been filed with 375 actions still pending. In August, a federal judge decided plaintiffs can not withhold their names from Allergen. Plaintiffs filed pleadings asking to use a pseudonym or initials to avoid disclosing personal medical information.

Common Facts

The MDL is addressing some common facts – when did Allergan know or should have known about the risks of textured breast implants and their connection to a rare form of cancer and whether the company provided adequate warnings, testing and manufacturing of the implants.

While the Allergan products were supposed to have been removed from the market last year, not all of the implants have been accounted for.

Because of that, the FDA on September 12, 2019 – FDA announces Class I global recall of Allergan Natrelle BIOCELL textured products, saline and silicone breast implants plus tissue expander. Class 1 is the most serious recall.

At that time, the agency found there were 573 BIA-ALCL cases involving 481 Allergan breast implants. This includes 33 deaths, frightening news for the more than 300,000 woman who have breast augmentation annually in the U.S.

The reason for the additional is incomplete device tracking data on about 52,000 BIOCELL breast implants. Patients were told to reach out to Allergan to determine if the company has their implant information or to contact the surgeon or hospital to retrieve their medical records.

Allergan also makes Biocell textured implants for other names including Natrelle, Inamed, and McGhan.

Initially, in July 2019, Allergan announced a worldwide voluntary recall of BIOCALL textured breast implants and tissue expanders, both saline and silicone filled. Allergan also makes Natrelle smooth and Microcell breast implants and tissue expanders which are not named in the recalls.

AbbVie (ABBV) a global pharmaceutical company based in Chicago, purchased Irish-based Allergan plc in May 2020 for $63 billion. Allergan is best known for its Botox and Juvéderm brands in the aesthetics division. This was one of the biggest deals in pharmaceutical industry.

Not Breast Cancer

In a new analysis, the FDA calls its findings a spike in cases. Among the 160 cases seen from July 2019 through January 5, 2020, the total of unique cases of BIA-ALCL came to 733. Three deaths were included. Of those cases reported to the FDA, 85 percent were Allergan implants.

A 2016 paper published in Aesthetic Surgery Journal found chronic inflammation from scar tissue may be the body’s way of responding to a foreign body, triggering an immune response and cancer. The lymphoma is always found in the scar tissue capsule.

Not only are the breast implants the subject of a recall but so are the tissue expanders, used in breast reconstruction following a mastectomy. An expander is intended to be a temporary implant.

The problem- a risk of anaplastic large cell lymphoma (BIA-ALCL), which is a cancer of the immune system. The FDA finds that the Allergen textured breast implant represents six times the risk of BIA-ALCL. The real-life consequences find that among 573 cases, 481 of those patients had the textured implants at the time of diagnosis.  Among the 573, there were 13 deaths.

The BIA-ALCL is usually successfully treated by removing the scar tissue and the implant. Additional radiation and chemotherapy may not be needed.

Chronic Inflammation

Why use a textured breasts implant?

Some surgeons have chosen a textured implant because they are reported to hold their position better and may be ideal for patients who have had mastectomy. Included in the recall is the Allergan Natrelle 133 and 133 Plus tissue expanders. To date they have not been associated with the cancer even though they have the same proprietary texture.

This recall is for the unused stock of BIOCELL implants and tissue expanders from doctor’s offices and hospitals. Patients with the troubling implants were told they did not need to have them removed.

Patients worried do not have to have the implants removed. Allergan had sent an urgent warning to U.S. customers, primarily surgeons, instructing them to return all unused implants.

As of early 2020, cases of ALCL associated with textured implants are blamed on 36 deaths and 733 cases of ALCL.

The cancer is identified in the scar tissue and fluid surrounding the implant. BIA-ALCL can spread throughout the body. Symptoms of this type of cancer are pain or swelling near the breast implant. Other symptoms of this type of cancer are:

  • Lumps in the breast or armpit
  • Breast hardening
  • Changes in the appearance of the breast
  • Redness or rashes
  • Weight loss
  • Fatigue

The BIOCELL textured implants represent less than 5% of the market of all breast implants in the U.S. and 10% of ALL breast implants sold in the U.S. Look at the FDA to determine if your particular textured breast implant is included.

LEARN MORE:

See NIH https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5908488/
https://trofire.com/2020/08/24/fda-announces-new-analysis-of-breast-implant-related-cancer-and-illness/

 October 2020 Medpage today
https://www.medpagetoday.com/hematologyoncology/breastcancer/88999

https://news.abbvie.com/news/press-releases/abbvie-completes-transformative-acquisition-allergan.htm

https://www.theguardian.com/business/2019/jun/25/botox-maker-allergan-bought-by-us-drug-giant-abbvie-for-63bn

July 2019
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders

June 2020
https://www.fda.gov/medical-devices/safety-communications/fda-requests-allergan-voluntarily-recall-natrelle-biocell-textured-breast-implants-and-tissue

In June of 2020, Allergan launched a multi-pronged campaign to contact patients who may not be aware of the year-long campaign.
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/allergan-voluntarily-recalls-biocellr-textured-breast-implants-and-tissue-expanders