Articles Posted in Defective Medical Devices

The year 2012 saw another major hip replacement recall which may require an intensive treatment plan for patients.

In July 2012, Stryker recalled two hip replacements, the Rejuvenate and ABG II modular-neck stems. Stryker initiated the voluntary recall due to the potential risks for fretting and corrosion at the junction of the metal stem and metal neck.

Several months later, product liability lawsuits have been filed in a few states and patients are still learning what the recall may mean for them. The recall came two years after DePuy Orthopedics recalled its all-metal hip implant, the ASR XL Acetabular System, in 2010. A study showed the DePuy hip implant failed in one of eight patients and required they undergo a second surgery within five years – compared to the industry standard of 15.

Medical devices are supposed to improve the quality of a patient’s health. When they are surgically implanted, patients expect an extensive recovery and regular medical check-ups. But no patient should expect the medical device to cause new injuries or to be recalled.

Medical devices are supposed to undergo a rigorous approval process with the Food and Drug Administration (FDA) before going on the market, but some screening fails to identify defective devices. Here are some things every patient using a medical device should be aware of regarding product recalls.

Who is Responsible for a Medical Device Recall? The FDA can legally require a company to recall a medical device. In many cases, however, companies recall their own medical devices.

Johnson & Johnson has agreed to pay about $600,000 to resolve three product liability cases involving its DePuy hip implants, which were recalled in 2010 after hundreds of patient complaints and a study emerged revealing a substantial device failure rate.

 

 

The New Jersey-based company settled the cases of three women who had filed claims in a Las Vegas court. All three women had required a second hip revision surgery to treat and correct their pain. Each will receive about $200,000. The cases had been scheduled for trial Dec. 3.

The next three lawsuits involving defective DePuy hip implants are set for January in a Maryland state court.

In August 2010, Johnson & Johnson’s DePuy unit recalled 93,000 of its ASR hip implants globally and 37,000 in the United States. The recall was announced alongside results of a study from a UK joint replacement registry, which showed 12 percent of patients required a second revision surgery within five years. The Food and Drug Administration (FDA) also reported it had received about 400 complaints from patients in the two years prior.

Since the DePuy hip recall, more than 8,000 patients across the country have filed lawsuits against the medical device maker, alleging the ASR hips are defective. About 6,000 of these have filed in federal court.

Patients claim the DePuy metal-on-metal hip implants are defective, saying they caused friction between the metallic ball and socket components. The recalled DePuy hip implant can wear down and produce metallic particles in patients’ bloodstreams, along with pain, joint dislocations, infections and bone fractures.

Johnson & Johnson said it has spent about $800 million on the hip implant recall.

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xray-heart-200.jpgThe Food and Drug Administration (FDA) has ordered St. Jude’s Medical to expand studies into Durata defibrillator leads, saying the heart devices are sufficiently similar to Riata leads, which were recalled last year. The agency is also seeking new data on Riata.

Defibrillators are implanted in patients with abnormal heart rhythms to regulate the heart beat. The medical devices are connected to the heart with leads. Riata was recalled because in some cases, wires were breaking through the insulation, which can potentially lead to a life-threatening abnormal heart rhythm.

A recent St. Jude study of 700 Riata patients found the defective wire broke through the insulation in about 19 percent of cases. A study led by a Minneapolis Heart Institute cardiologist has linked Riata leads to 20 deaths.

St. Jude, of St. Paul, Minnesota, pulled the defective Riata leads off the market in December 2010 and the FDA issued a medical device recall in late 2011. A 2011 count found 79,000 patients were still implanted with the Riata leads.

Responding to the FDA order, St. Jude said it is already collecting data on both Riata and Durata. The company stated the medical devices are different in design and a new coating meant to protect the insulation.

The FDA’s orders include routine X-rays for patients enrolled in post-market Durata studies to identify any insulation problems. St. Jude must also perform X-rays in a three-year post-market study on the defective Riata leads. The goal is to detect extruded leads which are floating loose in the heart.

Surgery to remove extruded leads can be dangerous. St. Jude says many patients live with the loose wires and continue to function normally. The FDA has advised doctors to closely monitor patients.

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Johnson & Johnson, one of the largest manufacturers of surgical mesh, has announced plans to stop selling the medical implants, as it faces hundreds of lawsuits from injured women and increasing oversight from the Food and Drug Administration (FDA).

Surgical mesh is used to strengthen the pelvic wall in cases of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Last year, approximately 75,000 women had a transvaginal procedure using surgical mesh.

Johnson & Johnson disclosed it will phase out surgical mesh in a recent letter sent to New Jersey and West Virginia judges overseeing patient lawsuits against them. The company said it plans to discontinue four mesh products over the next three to nine months.

On July 13, 2011, the FDA issued a public safety advisory stating traditional POP repair with mesh has no advantage over traditional non-mesh repair. Between 2005 and 2010, more than 3,800 women had reported complications and injuries following transvaginal mesh surgery, according to the FDA.

Many more women have stepped forward since the FDA advisory, many of whom have suffered painful, long-term injuries. Some injuries cannot be corrected through surgery. Hundreds of women have filed lawsuits against the manufacturers, which include Johnson & Johnson and Boston Scientific.

In September 2011, an FDA panel heard arguments from advocacy groups, surgeons and consumer organizations. Many wanted to see a surgical mesh recall, others wanted the FDA to implement more oversight. Some sought a reclassification while others said the surgical mesh problem made another case for overhauling the 510(k) system, which allows manufacturers to sell new products without a new review so long as they are “substantially equivalent” to an already legally marketed device.

The FDA did not require a surgical mesh recall. But in January 2012, it ordered Johnson & Johnson and the other companies to conduct studies to track surgical mesh complication rates over time. Johnson & Johnson has been collecting data to comply, but said it expects the FDA will waive the requirement.

Complaints from transvaginal surgical included mesh erosion with in the body, bleeding, pain during sexual intercourse, organ perforation, vaginal scarring, muscular and emotional problems. While corrective surgery is an option, it is not always successful.

Some surgeons are now recommending women consider whether they really need POP surgery and if they do, request a procedure without mesh, according to a Consumer Reports article. Click here for a recent article.

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medical-instruments-200.jpgThe Food and Drug Administration (FDA) is studying why some medical facilities are failing to properly sterilize medical devices for reuse in surgeries and endoscopy procedures.

The result is patients are being exposed to microscopic amounts of blood, body fluids and tissues from other patients, according to a recent FDA Consumer Update. This exposure may have resulted because the devices were not properly reprocessed, cleaned, disinfected or sterilized.

Patients are being exposed through surgical instruments such as clamps, forceps and endoscopes. Endoscopy procedures are often performed to diagnose cancer and other illness.

The FDA states that transmission of infection was extremely rare in reports it has received about patient exposure. It states the risk for acquiring an infection from a reused medical device is low.

The FDA states patients can protect themselves by learning about their medical procedure and asking their medical facility what steps it takes to reprocess surgical instruments.

The agency suggests patients also research their procedures on the websites of professional organizations, such as the American Academy of Family Physicians.

The FDA is working to prevent this type of medical malpractice by:

  • Making sure manufacturers are providing clear cleaning instructions.
  • Making sure hospitals and staff understand and follow the instructions.
  • Improving medical device design to facilitate cleaning and sterilization.

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Medical insurance companies are alerting patients who have defective all-metal hip implants that they will seek to recover expenses from any settlement money which patients receive. Medicare is also expected to try and recover its costs.

Thousands of patients have been affected by recent recalls of all-metal hip implants and are expected to seek compensation from manufacturers. Although insurance companies, by statute or contract, often have the right to recover some of their costs, it is unusual for companies to be so assertive for medical device failures. The aggressive actions being taken by the insurers reflect their awareness of just how expensive these defective products are becoming.

In August 2010, DePuy recalled the ASR XL Acetabular System. The hip implant is defective because it causes friction between the metallic ball and socket components, which are implanted to replace the femur and acetabulum.

The recalled DePuy hip implants can wear down and produce a substantial amount of metallic particles in patients’ bloodstreams. Patients reported signs of metallosis, including pain, swelling, problems walking and rashes. Other serious problems may include bone fractures, joint inflammation, hip dislocation and damage to the tissue, hip implant loosening, nerves and muscles near the implant.

DePuy recalled the defective hip implants after the Food and Drug Administration (FDA) received about 400 complaints in two years from patients. That number has grown significantly following the recall. In just the first six months of 2011, the FDA received more than 5,000 reports about problems with all-metal hip implants, according to an analysis by The New York Times. DePuy hip implants accounted for 75 percent of the complaints.

It is still unclear how many patients have been affected by defective metal hip implants. The New York Times reports one estimate that 500,000 patients have received an all-metal replacement hip.

The newspaper reports another estimate that 250,000 hip replacements are performed in the United States each year. Until recently all-metal hip implants accounted for nearly one-third of these procedures.

As of October 2011, 3,500 patients filed lawsuits against DePuy in connection with last year’s recall. DePuy also faces over 560 lawsuits in connection with the Pinnacle, another defective all-metal hip implant.

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More lawsuits are expected against DePuy and other manufacturers as patients start experiencing pain and requiring corrective surgery. This procedure can be painful, require substantial post-operation bed rest and treatment and cost hundreds of thousands of dollars.

Click here to read more about all-metal hip implants in the New York Times.
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contactlens.jpgConsumers are advised to stop using a second type of CooperVision’s Avaira contact lenses due to a defect that may result in blurry vision and other eye injuries.

On Nov. 16, an unknown quantity of CooperVision Avaira (enfilcon A) Sphere contact lenses were recalled due to the unintended presence of a silicone oil residue.

CooperVision, a Fairport, NY-company, recalled the lenses in cooperation with the Food and Drug Administration (FDA), which states that the silicone oil residue can result in a wide range of symptoms, including eye discomfort, hazy and blurry vision and eye injuries requiring medical treatment. The FDA regulates contact lenses as a medical device.

The recalled lenses were manufactured from Feb. 1, 2011 to Aug. 24, 2011 and distributed from March 2, 2011 to Nov. 15, 2011.

The contact lenses were used to correct myopia and hyperopia and non-aphakic individuals with non-diseased eyes. The lenses may be worn by individuals who have astigmatism of 2.00 diopters or less that do not interfere with visual acuity.

Lens wearers have been instructed to stop using the lenses immediately and contact their eye care professional. They can visit the CooperVision recall website and enter the defective medical device package numbers to determine if their lenses have been recalled.

The medical device recall expanded another in August 2011 for limited lots of Avaira Toric contact lenses. CooperVision said the product defect on that line has been corrected through its quality system process.

Contact lens injuries are prevalent, due to product defect or improper use. They are most common among children and adolescents. In a study published in the July 2010 Pediatrics, FDA researchers reported 23 percent of total medical device injuries in 2004 and 2005 in the U.S. involved children and contact lenses. Children ages 11 and over were the most affected.

Common personal injuries include corneal contusions and abrasions, hemorrhage and conjunctivitis.

Click to read the FDA notice about the CooperVision recall.
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A Food and Drug Administration (FDA) advisory panel has recommended that some transvaginal mesh products be reclassified as the process for approving mesh and other medical devices comes under scrutiny.

On July 13, the FDA updated a 2008 public health notification, reporting that complications from transvaginal mesh are not rare and that it is not clear that transvaginal mesh surgery is more effective than non-mesh repair of pelvic organ prolapse (POP). Having received over 3,800 reports of complications, the FDA urged surgeons to consider other options before performing transvaginal mesh surgery.

Since then, more than 600 women have filed lawsuits over complications from transvaginal mesh, which is surgically implanted to treat both POP and stress urinary incontinence (SUI). POP occurs when a women’s pelvic muscles and organs are weakened and stretched, often after child birth or hysterectomies.

Women reported painful complications such as internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems. Corrective surgery is often required and is not always successful. In one report by Bloomberg News, a woman reported she had undergone 17 procedures to reverse damage from transvaginal mesh, including five surgeries, and is still suffering from the condition.

The FDA approved the first transvaginal mesh product, ProtoGen by Boston Scientific, in 1996. Two years later, Johnson & Johnson won approval for a similar device called Gynecare VT, but was not required to conduct human testing on it. Using the FDA’s 510(k) process for medical devices, Johnson & Johnson was allowed to bypass testing by claiming the device was “substantially equivalent” to the Boston Scientific mesh product.

The FDA approves 90 percent of medical devices under the 510(k) process, including defective hip implants and external heart defibrillators that have been subject to recalls in recent years.

Critics say the 510(k) process is flawed and needs to be overhauled. In the case of Boston Scientific, the Massachusetts manufacturer recalled its surgical mesh product in 1999 as other companies were just starting to bring their product to market. There are a total of nine manufacturers of transvaginal mesh products.

In January, the FDA announced it was considering 25 changes to the 510(k) system. In July, the non-profit U.S. Institute of Medicine issued a warning about it and Congress has pushed the FDA to make changes.

As for transvaginal mesh, the FDA convened an advisory panel to review the safety of the medical device in September. The 17-member panel recommended that some transvaginal mesh be reclassified as high-risk devices and require new studies be conducted to stay on the market. The FDA has yet to make a decision.
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A Food and Drug Administration (FDA) panel will begin discussing the safety and effectiveness of urogynecologic mesh products Wednesday. Surgical mesh is a medical device that is implanted into a woman during transvaginal mesh surgery.

On July 13, the FDA issued an update on a 2008 public health notification reporting complications from surgical mesh used in transvaginal mesh surgery are not rare. It also reported it was not clear that transvaginal mesh surgery is more effective than non-mesh repair of POP.

Transvaginal mesh surgery is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). POP occurs when the tissues that hold the pelvic organs become weakened or stretched. SUI is a bladder condition.

In its July 13 update, the FDA reported it had received more than 3,800 reports of complications about transvaginal mesh surgery between 2005 and 2010. It urged surgeons and physicians to consider other options before performing the surgery.

Possible transvaginal mesh complications include internal mesh erosion, pain during intercourse, infection, bleeding, organ perforation and urinary problems.

The FDA warned that surgical mesh is a permanent implant that may require several surgeries to correct. Full removal of surgical mesh may not be possible.

The FDA will convene its Obstetrics-Gynecology Devices Panel of the Medical Device Advisory Committee on Wednesday and Thursday (September 8 and 9, 2011). The panel will discuss the safety of transvaginal surgical mesh for POP and SUI.

One consumer advocacy group has called for the FDA to recall surgical mesh. Public Citizen of Washington, D.C. – the organization founded by Ralph Nader – has also asked the FDA to reclassify surgical mesh so that future releases must undergo a more stringent approval process.

Other medical professionals support the procedure. A nationwide group of 600 pelvic surgeons has submitted a letter to the FDA challenging findings involving surgical mesh injuries.

Nine companies manufacture surgical mesh, including Boston Scientific and Johnson & Johnson.

If you have been injured during transvaginal mesh surgery, it is important to contact an experienced Boston medical device recall lawyer who can protect your interests as the FDA conducts its review. An attorney can advocate for you and ensure you obtain compensation for your injuries.

For a free legal consultation, contact the Boston lawyers at Breakstone, White & Gluck in Boston at 1-800-379-1244 or use our contact form.
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