Transvaginal Mesh Sales Halted
The U.S. Food and Drug Administration (FDA) has ordered makers of transvaginal surgical mesh implants to immediately stop the distribution and sale of the products in the United States.
The FDA said that Boston Scientific and Coloplast, the last two companies selling these products in the U.S., have not demonstrated “a reasonable assurance of safety and effectiveness for these devices”.
Transvaginal Mesh Used for Pelvic Organ Prolapse
Transvaginal mesh is used in surgery to repair pelvic organ prolapse (POP) a common medical condition in which the muscles and tissue supporting the pelvic organs (the bladder, uterus, and rectum) become weak or loose. This allows the pelvic organs to press on, into, or out of the vagina. One in eight women will have surgery to repair POP over her lifetime.
History of FDA and Transvaginal Mesh
The FDA approved the first pelvic mesh device for transvaginal repair of POP as a class II moderate-risk device in 2002. Since then, thousands of women and their doctors have filed complaints of injuries resulting from implanted vaginal mesh after POP surgery. The agency issued its first safety communication about pelvic mesh in 2011.
The FDA reclassified vaginal mesh as Class III (high risk) in 2016. As a result of the reclassification, manufacturers were required to obtain premarket approval applications (PMAs), the FDA’s most stringent method of approving medical devices. Some manufacturers voluntarily recalled or discontinued vaginal mesh in the last few years as safety concerns grew.
FDA Ended Sales for Safety of Patients
In reviewing the PMA data submitted by Coloplast and Boston Scientific, the FDA determined that the data didn’t show surgery using mesh was better than surgery using native tissue. Therefore, the benefit of mesh did not outweigh the risk of injury, and the products are not safe to use.
Even though they can no longer sell the devices, Boston Scientific and Coloplast are “required to continue follow-up of the subjects already enrolled in their 522 studies.”
What To Do If You Have Defective Transvaginal Mesh
Any woman who has implanted mesh for POP who is having pain or other complications should contact her doctor immediately. The injuries caused by defective transvaginal mesh include infection, vaginal bleeding or discharge, severe pelvic or groin pain, pain during intercourse, urinary problems, and even organ perforation from implanted mesh eroding into surrounding tissues. Do not delay seeking medical attention if you are in pain.
If you have been injured by a defective transvaginal mesh implant and would like to explore your legal options, call the pelvic mesh lawyers at Thornton Law Firm to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your legal rights.
Call 888-341-1405 for a free consultation with a recognized leader in personal injury and defective drug litigation. You can also contact us online to discuss the details of your case.
Published on May 16, 2017
The FDA has added a boxed warning to the label of diabetes drugs containing canagliflozin (Johnson & Johnson’s brand names Invokana and Invokamet) to warn that these drugs carry an elevated risk of leg and foot amputations.
FDA Confirms Doubled Risk of Lower Limb Amputation When Taking Canagliflozin Drugs
Today’s FDA Drug Safety Communication confirms the approximately doubled risk of lower limb amputations for patients taking Invokana (canagliflozin) or Invokamet (canagliflozin with metformin). The warning is based on new data from two large clinical trials. CANVAS (Canagliflozin Cardiovascular Assessment Study) and CANVAS-R (A Study of the Effects of Canagliflozin on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus) showed about double the rate of amputations from diabetes patients on canagliflozin drugs, as compared to patients taking a placebo. Amputations mostly affect the toes and the middle of the foot. Amputations of the leg, below and above the knee, and to both limbs were also observed.
Europe Requires Amputation Warning on All SGLT2 Inhibitor Drugs, Not Just Canagliflozin
Invokana and Invokamet are classified as sodium glucose cotransporter-2 (SGLT2) inhibitor drugs. SGLT2s trigger the kidneys to release blood glucose into the urine, thereby lowering blood sugar levels. The European Medicines Agency issued a requirement in February of 2017 that the labels of every drug in the SGLT2 inhibitor class carry the amputation warning. The other drugs included as well as canagliflozin (brand names Invokana, Invokamet) are dapagliflozin (brand names Farxiga, Xigduo XR) and empagliflozin (brand names Jardiance, Glyxambi, Synjardy).
FDA Recommendations for Diabetes Patients and Their Health Care Providers When Using Canagliflozin
The FDA issued the following recommendations to patients, and to health care providers:
Patients taking canagliflozin should notify your health care professionals right away if you develop new pain or tenderness, sores or ulcers, or infections in your legs or feet. Talk to your health care professional if you have questions or concerns. Do not stop taking your diabetes medicine without first talking to your health care professional.
Health care professionals should, before starting canagliflozin, consider factors that may predispose patients to the need for amputations. These factors include a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Monitor patients receiving canagliflozin for the signs and symptoms described above and discontinue canagliflozin if these complications occur.
Reporting Adverse Events While Taking Invokana and Invokamet
The FDA encourages patients health care professionals and patients to report adverse events or side effects related to the use of canagliflozin and other medicines to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. You can do this by calling 800-332-1088 to request a reporting form; by using their online reporting form; by downloading an online form and submitting by mail, or by faxing the form to 1-800-FDA-0178.
What Can You Do?
If you have taken the canagliflozin-containing diabetes drugs Invokana or Invokamet, or any other SGLT2 inhibitor drug, and suffered an amputation, you may have a claim for damages. Contact the defective drug attorneys at Thornton Law Firm for a free, thorough evaluation of your legal rights at 1-888-341-1405. Or tell us your story using our online contact form. Like all lawsuits, Invokana claims must be filed within short time limits. Seek legal advice as soon as possible to protect your rights.
Call 888-341-1405 for a free consultation with a recognized leader in personal injury and medical device litigation. You can also contact us online to discuss the details of your case.
Published on April 27, 2017
On March 31, the U.S. Food and Drug Administration (FDA) announced a manufacturer’s voluntary recall of a popular brand of auto-injector medical device – the Epipen – used to treat patients with severe allergies. This announcement came nearly two weeks after a similar recall was issued for the same devices in seven other countries. The recalls were a direct response to consumer complaints that the devices failed to operate as marketed.
Mylan Acknowledges Some EpiPen, EpiPen Jr Units May Have Defective Parts
Mylan NV sells the EpiPen and EpiPen Jr auto-injectors, which are actually manufactured by Pfizer. Both devices are designed to inject epinephrine–adrenaline–into patients who suffer from severe allergic reactions. When a patient goes into sudden anaphylactic shock, pressing the EpiPen or EpiPen Jr into the thigh is supposed to deliver an instant dose of epinephrine.
But according to news reports, Mylan admitted there have been at least two cases where the EpiPens failed to work. The company said the two affected patients “were able to use different EpiPens” and did not suffer any permanent damage. Nevertheless, Mylan issued a voluntary recall on March 20 for approximately 80,000 EpiPens sold in Australia, New Zealand, Japan, Denmark, Norway, Finland, and Iceland.
The March 31 notice extended that recall to the United States. The FDA said that at the present time, 13 specific lots of EpiPen and EpiPen Jr distributed between December 17, 2015, and July 1, 2016, were under recall. This includes devices with the following lot numbers:
Mylan claims the defective EpiPens “may contain a defective part” that prevents them from activating correctly. If that happens, the FDA warns there is a “life-threatening risk” of an improperly treated allergic reaction. Mylan is offering free replacements of any defective units. Customers can contact Mylan online or call 877-650-3494 for more information.
Have You Been Injured Due to a Defective Drug or Medical Device?
Even before these recalls, Mylan was already facing public scrutiny for its marketing of the EpiPen. Last year, the per-pen price rose more than 600 percent–from $47 to $284–and since the company only sold the EpiPen in pairs, many consumers were paying more than $600 to fill a prescription. Following a Congressional investigation, Mylan promised to “reimburse consumers for some of their out-of-pocket costs.”
Regardless of cost, drug manufacturers have a legal and moral obligation to produce safe, effective products. If you have been injured due to a defective EpiPen or any other medical device, it is important to speak with a Boston defective drug lawyer as soon as possible. Call Thornton Law Firm, LLP today at 888-341-1405 to schedule a consultation with one of our attorneys, or tell us your story here and we’ll call you to discuss your legal options..
Call 888-341-1405 for a free consultation with a recognized leader in personal injury and medical device litigation. You can also contact us online to discuss the details of your case.
Published on December 12, 2016
Essure, Bayer’s permanent birth control device, was recently ordered to carry a black box warning by the Food & Drug Administration (FDA). A black box warning is the FDA’s highest level of regulation, meaning that the product may cause death or serious injury. In addition, all patients must now complete a Patient Decision Checklist before having the device implanted. This action by the FDA follows years of complaints by women who received the Essure implant and suffered a number of serious injuries which they attribute to the device.
What is Essure?
Essure is a permanent birth control method. It is a type of tubal sterilization that does not require a surgical incision or anesthesia. The Essure device consists of two spring-like metal (nickel and tungsten) coils that have plastic (polypropylene) fibers wound through them. The coils are implanted in a woman’s fallopian tubes, where the plastic irritates the tissue so that it forms scar tissue. The scar tissue prevents the woman from becoming pregnant.
Essure’s Manufacturing History
Essure was first introduced to the market by Conceptus, Inc., in 2002 after three years of clinical trials. Conceptus was purchased by Bayer AG on June 5, 2013 and is now a wholly-owned subsidiary of the German pharmaceutical company.
Problems with Essure implant
Early on women who were implanted with the device complained about having severe side effects after receiving Essure. Some of the injuries associated with the Essure implant include:
- Allergic or hypersensitivity reactions to the device
- Autoimmune response, including fatigue, hair loss, rashes, swelling, itching, and weight gain
- Chronic, severe pelvic pain
- Expulsion of the device
- Fetal death
- Life-threatening ectopic pregnancy
- Migration of the device or a device component in the abdominal or pelvic cavity
- Perforation or tearing of pelvic organs, including fallopian tubes or uterus
- Surgeries to remove the device and to repair internal organs
Pressure on FDA to Remove Essure from Market
The Essure Problems Facebook group was started in 2011 by a woman named Angie Firmalino, who wanted to be able to discuss her Essure implant injuries privately. That group now has more than 31,000 members. She is now the President of a non-profit, ASHES—Advocating Safety in Healthcare E-Sisters part of whose mission is advocating for Essure victims. Between Essure’s introduction in 2002 and December 31, 2015, 9,900 women and doctors have filed complaints about Essure with the FDA. In addition, women who were part of the original Conceptus clinical trials have come forward to say that their data was misreported or changed by Conceptus.
On Sept. 24, 2015, a public meeting of the FDA’s Obstetrics and Gynecology Devices Panel was held“to discuss the risks and benefits of Bayer HealthCare’s Essure System for permanent female sterilization.” Both medical professional and women who had received the Essure implant testified. In February 2016 the FDA ordered Bayer “to conduct a postmarket surveillance study to obtain more data about Essure’s benefits and risks”. Finally on November 5, 2016 the FDA ordered the black box warning added to the product packaging, warning of the risks of the Essure device.
What Can You Do?
If you or a loved one has suffered injuries you believe are related to the Essure birth control device, call Marilyn McGoldrick at Thornton Law Firm for a free, confidential consultation. You can call us at 1-888-341-1405 or tell us your story online for a no-obligation evaluation of your legal rights. As with all legal claims, Essure lawsuits have short time limits. Seek legal advice as soon as possible as legal time limits are strictly enforced.
Published on June 20, 2016
The Zecuity Migraine Patch (sumatriptan iontophoretic transdermal system) is being investigated by the FDA for potentially causing serious burns and permanent scarring. The manufacturer, Teva Pharmaceuticals, has temporarily stopped selling, marketing and distributing the Zecuity skin patch after receiving what the FDA described as “a large number” of serious adverse skin reactions. In a letter to healthcare providers, Teva outlined these skin reactions, including:
- Severe redness
- Cracked skin
- Burns or scars where the patch was worn
- Severe pain
- Skin discoloration that lasts months
The Zecuity patch is a battery-operated, disposable patch intended to treat migraine headaches. The patient wraps the Zecuity patch around their thigh or upper arm to deliver the medicine sumatriptan through the skin. The patch is supposed to be worn for four (4) hours. The Zecuity patch has only been on the market since September of 2015.
The FDA announced it was investigating the risk of burns and scars with the Zecuity (sumatriptan) migraine patch on June 2, 2016. Teva Pharmaceutical announced the temporary suspension of sales eight days later on June 10, 2016.
If you have any Zecuity patches, stop using them and contact your doctor about another migraine medication. Patients and physicians can report adverse events to Teva at 1-800-896-5855 and to the FDA’s MedWatch Adverse Events Reporting Program.
If you have suffered burns or scarring or other severe reactions after using the Zecuity migraine patch, you may contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. There is no obligation and all consultations are completely confidential. Like all legal claims, Zecuity patch claims have short, strictly enforced time limits. Do not delay seeking legal advice.
If you have suffered injury caused by a defective drug or medical device, call 888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.
Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.
The Rotabator Rotational Atherectomy System is used to surgically remove atherosclerosis from arteries. The device uses a tiny burr rotating at high speed to remove plaque and improve blood flow to the heart. The tip of the device rotates at 190,000 rotations per minute during the procedure.
The recall covers 955 devices distributed in the following states: Arizona (AZ), California (CA), Delaware (DE), Florida (FL), Georgia (GA), Illinois (IL), Louisiana (LA), Maryland (MD), Mississippi (MI), Minnesota (MN), Nebraska (NE), New York (NY), Pennsylvania (PY), South Carolina (SC), Texas (TX), Washington (WA), and Wisconsin (WI). The recalled devices were manufactured from June 26, 2015 to Sept. 10, 2015 and distributed from July 9, 2015 to Oct. 1, 2015.
Boston Scientific sent hospitals an Urgent Medical Device Recall letter in October of 2015 asking them to stop using the device immediately. The FDA announced the Class 1 recall of the device in November.
If you believe you suffered injuries as a result of a faulty Boston Scientific guidewire, contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.
Patients who have acquired a superbug CRE infection after undergoing an ERCP endoscopy can call 1-888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.
Antibiotic-resistant superbug infections caused by duodenoscopes have become more and more common. In an effort to prevent future infections, the FDA has ordered the three manufacturers of duodenoscopes to perform postmarket surveillance on how the devices are being cleaned and sterilized (reprocessed) in clinical settings.
Duodenoscopes are a specialized endoscope used for one medical procedure: the ERCP, which stands for endoscopic retrograde cholangiopancreatography. The ERCP is the least invasive way to examine and treat pancreas and bile ducts blocked by cancerous tumors, gallstones, or other conditions. Like all endoscopes, the duodenoscope consists of a tube fitted at the end with a tiny camera and a light that allows the gastroenterologist to see the area being treated. They also contain a tiny moving part known as an elevator which allows a tube or a stent to be inserted into the ducts. The devices are reusable and the elevator part is extremely difficult to clean properly between uses.
The FDA has ordered the three manufacturers of duodenoscopes — Olympus America, Fujifilm Medical Systems, USA, and Hoya Corp. (Pentax Life Care Division) — to submit plans for the surveillance studies within 30 days. The manufacturers must study how the devices are actually being used and whether hospital personnel are following the manufacturer’s recommendations for reprocessing.
The order follows several deadly outbreaks of CRE — carbapenem-resistant Enterobacteriaceae — in hospitals across the country, and the world, over the past two years. In February the FDA noted 135 possible infections from duodenoscopes had been reported from January of 2013 to December of 2014. The most recent reported outbreaks were at UCLA’s Ronald Reagan Medical Center and Cedars-Sinai Medical Center in Los Angeles.
For now, the FDA has decided to allow the devices to stay on the market, finding that the benefits of diagnosis and treatment via ERCP outweigh the risk of infection. Patients are advised to discuss risks and benefits of the procedure with their doctors, and after undergoing ERCP be aware of these potentially dangerous complications:
Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools)
If you or someone you love has been injured by a superbug infection after an endoscopy procedure, call the duodenoscope lawyers at Thornton Law Firm at 1-888-341-1405 for a free, no-obligation consultation, or tell us your story here. Like all legal claims, superbug infection claims have short, strictly enforced time limits, so seek legal advice at your earliest opportunity.
Published on April 3, 2015
The Zimmer Persona Trabecular Metal Tibial Knee Implant is being voluntarily recalled after an unexpectedly high complaint rate of 61% for all the procedures in which it was used. The recall was announced by the FDA in March in response to complaints of loosening of the implant, as well as asymptomatic radiolucent lines in x-rays, representing space between the implant and the bone. The recall affects 11,658 patients who received the Zimmer Persona implant. If you or a loved one received a Zimmer Persona implant, contact Thornton Law Firm today for a confidential evaluation of your legal rights.
Zimmer issued Urgent Medical Device Recall letters to affected distributors, hospitals, and surgeons, recalling all of the Persona Knee Implants. The FDA classifies the recall as Class 2, meaning that the defect “may cause temporary or medically reversible adverse health consequences.” These health consequences can be severe. A loosened knee implant may require the patient undergo costly and painful revision surgery. Loosening and radiolucent lines can also cause many other problems. Tissue, joint fluid, and debris from the failing implant can lodge in the spaces between the gaps between the implant and the bone. This can cause swelling, severe pain, tissue damage, and bone damage.
One of the largest medical device manufacturers in the world, Zimmer, Inc. advertised the Persona Knee Implant as “the Personalized Knee System”. It was on the market for 3 years and distributed in 25 states, as well as worldwide. The recall covers all sizes and lots of the Persona Knee Implant.
If you have a Zimmer Persona Knee Implant and have experienced complications including pain, swelling, loosening, disability, or have undergone revision surgery, you may have a legal claim against Zimmer, Inc. Thornton Law Firm’s medical device lawyers specialize in helping patients who have suffered complications after receiving defective devices. Please contact us at 888-341-1405 or tell us your story here. All consultations are free and confidential.
Posted on Mar 4, 2015
The FDA has announced two important changes to the labeling of testosterone replacement (LowT) products. First, the makers of testosterone replacement medication must change the labels to make clear that “prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.” Prior to this directive, testosterone was widely advertised and prescribed to men with symptoms of aging such as loss of muscle mass, low sex drive, fatigue, and depressed mood. The FDA’s Drug Safety Communication says that: “FDA has become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging. The benefits and safety of this use have not been established. for men with the typical symptoms of aging.”
The FDA has also strengthened the safety warnings on the label of testosterone products. Manufacturers must now add a warning about a possible increased risk of heart attacks, strokes, and other cardiovascular events in patients taking testosterone. Drugmakers must also conduct a long-term study about the safety of testosterone “to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products.”
The new requirements track the recommendations made by the experts appointed last year to advise the FDA on these issues. The panel had voted 20-1 to limit prescription testosterone to a narrow list of actual medical conditions, and recommended further studies be undertaken on the risk of cardiovascular conditions such as heart attack and stroke.
Testosterone replacement has boomed over the past few years, fueled by millions of dollars in advertising. Over 2 million men take the supplements, and sales of testosterone replacement products are over $2 billion dollars and climbing.
This new FDA Drug Safety Communication only allows advertising or marketing of the drugs to persons whose low testosterone was caused by one of the recognized medical conditions originally approved for testosterone replacement, like pituitary tumors or genetic disorders. The FDA notes that the most common diagnosis for which testosterone therapy is currently prescribed is the not very specific “testicular hypofunction, not elsewhere classified.” The FDA is putting the brakes on the LowT industry. Most of the recent increase in prescriptions for testosterone replacement has gone to men aged 45 to 64 who are prescribed the drug for so-called LowT.
Thornton Law Firm is investigating claims for men who have suffered cardiovascular events while taking prescription testosterone replacement therapy. If you believe that you may have suffered a heart attack or stroke after taking testosterone replacement therapy, contact the LowT lawyers at Thornton Law Firm for a free, completely confidential consultation. Call us on our toll-free number 888-341-1405 to talk to one of our testosterone replacement lawyers, or tell us your story here. Lawsuits are subject to strict legal time limits so do not delay seeking legal advice if you believe you have a claim.
Posted on Sep 25, 2013
Dr. Frances Oldham Kelsey
Released in Germany in 1957 as an all-purpose sedative, but later widely used as a preventative treatment for “morning sickness,” Thalidomide caused an estimated 10,000 – 20,000 severe birth defects worldwide. The injuries associated with a mother’s ingesting Thalidomide while pregnant included birth without limbs, shortened limbs, deformed hearts and eyes, and blindness and deafness. It is estimated that 39-50% of babies born with Thalidomide-related birth defects died within a few months of birth. Thalidomide’s use increased after the drug became available over-the-counter in 1960. Before its use was banned, however, Thalidomide had been linked to birth defects in more than 39 countries.
The pharmaceutical company Richardson-Merrell (now Marion Merrell Dow) sought approval for sale of Thalidomide in the United States in June 1960. Because of a loophole in the approval process, however, Richardson-Merrell was able to distribute millions of doses of Thalidomide to more than a thousand doctors in the United States while the drug was being investigated. About 20,000 patients in the United States took Thalidomide as a result. Despite efforts to win quick approval from the Food and Drug Administration, Richardson-Merrell ran into an immovable force in the person of Frances Oldham Kelsey. Dr. Kelsey, who had only recently joined the FDA as a reviewing pharmacologist, resisted the requests for approval to market the drug and instead asked for more controlled studies related to Thalidomide’s risks. When studies showed that the drug’s use had lead to more than 10,000 severe birth defects worldwide, Richardson-Merrell pulled their application for approval. In 1962, Thalidomide was banned worldwide. Compared to other countries, only a relative handful of children in the United States were born with Thalidomide-related injuries. For her efforts, Frances Oldham Kelsey received the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy in 1962 and continued her work at the FDA.
As a result of the Thalidomide tragedy, many new regulatory reforms were enacted in order to better protect American consumers. Congress passed new rules related to testing and licensing of drugs.
Unfortunately, the potential for birth defects resulting from a mother’s use of pharmaceutical drugs is still present today. A new, peer-reviewed study has found that children born to mothers who took common prescription painkillers, like Vicodin, Oxycontin, or Percocet, at or near the time of conception were more than twice as likely to be born with neural tube defects such as spina bifida. The scientists found a strong association between mothers who took these prescription opioid painkillers and a significantly increased risk of having a child with one of these serious neural tube birth defects.
If you took an opioid painkiller around the time of conception and your child was born with a neural tube birth defect, please contact attorneys David Strouss or Marilyn McGoldrick at 888-341-1405 to discuss your legal rights with our experienced team of birth defect lawyers.