Dangerous Medical Devices

Each year millions of people use a variety of medical devices believing they are safe, but they may be poorly designed or manufactured with serious consequences to the user. FDA approval does not guarantee that a device is safe. Unfortunately, there are many examples of manufacturers who knew or should have known their products were dangerous long before they were recalled from the market. Recent examples of dangerous medical devices include:

See examples of our dangerous drugs and medical devices cases.

Metal-on-Metal Hip Implants

Warnings have been issued for problems associated with metal-on-metal hip implants, such as:

  • Biomet M2A and M2A-Magnum Hip Replacement Systems
  • DePuy ASR XL Acetabular System
  • DePuy ASR Hip Resurfacing System
  • DePuy Pinnacle
  • Stryker Rejuvenate, ABG II Modular-Neck Systems, and LFIT V40 Femoral Heads
  • Wright CONSERVE® Total Hip Implant System
  • Zimmer Durom Cup

Many patients who have received metal-on-metal hip implants experience significant problems after hip-replacement surgery, including significant pain, swelling, and difficulty walking caused by loosening, fracture, or dislocation. This results in the need for additional surgery to remove and replace the implant. In addition, high levels of metal ions may be released from the implants, causing metallosis (a build-up of metallic debris), necrosis (tissue death), or osteolysis (bone degeneration and death).

In January 2013, the U.S. Food & Drug Administration (FDA) issued a warning for metal-on-metal hip implants, noting that this design was failing at a higher rate than devices constructed of other materials. The FDA advised metal-on-metal hip implant recipients to get blood tests if they experience pain and swelling around the joint, mobility issues, or other signs of a failing implant. The FDA also proposed new rules for metal-on-metal hips, including a requirement that manufacturers conduct safety studies on their current products if they continue to sell them.

A May 2013 Bloomberg.com report stated that the FDA’s scrutiny of metal-on-metal implants prompted a decision by DePuy Orthopaedics to stop selling such devices, including the all-metal Pinnacle.

DePuy had already recalled its ASR XL Acetabular System and ASR Hip Resurfacing System in 2010. Design flaws with these implants were known by DePuy for years before the recall. Stryker recalled its two modular-neck components because they can corrode or shed metal where the stem and neck overlap, resulting in tissue damage or metallosis.

In August 2016, Stryker voluntarily recalled select models of its LFIT V40 metal femoral heads. The devices have been associated with corrosion and metal debris, which can lead to serious health consequences and require surgery to remove and replace the hip implant. Diamond~Massong is currently reviewing cases in which revision surgery has been required to replace V40 metal LFIT femoral heads (not C-Taper LFIT heads).

Diamond~Massong has handled many cases involving metal-on-metal hip implants. If you have had problems after hip-replacement surgery with one of the above implants, contact us for assistance.

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Hernia Mesh

Many people with hernias require surgery to alleviate daily pain and other symptoms. Diamond~Massong is currently reviewing cases of people who have had complications or need revision surgery because of polypropylene mesh used to strengthen weakened or damaged tissue in hernia repair, including Ehicon Physiomesh Flexible Composite Mesh or Atrium’s C-QUR surgical meshes. Complications include hernia recurrence, severe or chronic pain, bowel obstructions, infections, mesh migration, adhesions, and other complications that have caused the mesh to fail or have required additional surgery to remove and replace these devices.

In May 2016, Ethicon voluntarily recalled its Physiomesh hernia mesh product from the market after two unpublished studies showed a higher failure rate of this mesh product compared to other, similar hernia repair devices. The FDA’s Canadian and Australian counterparts posted notifications of the voluntarily recall in June 2016.

Diamond~Massong is currently reviewing cases involving severe complications from hernia mesh.

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Transvaginal Mesh

Transvaginal mesh (TVM) is a synthetic mesh product used to treat pelvic organ prolapse and stress urinary incontinence in women. Pelvic organ prolapse (POP) occurs when the tissues that hold the pelvic organs in place become weak or stretched. This may occur due to injury, childbirth, surgery, or age. POP can cause the bladder, bowel, or other organs to collapse and sag, causing incontinence and pelvic pain. Stress urinary incontinence (SUI) is a disorder in which weakened sphincter pelvic muscles allow urine to leak from the bladder during muscle spasms caused by coughing, sneezing, laughing, or physical activity.

TVM manufacturers exploited a loophole in FDA regulations in order to bypass testing of this product for specific women’s health issues. (The product was previously known for its use in hernia repairs.) The mesh was promoted to replace the traditional methods of surgical and nonsurgical repair. The mesh patch is surgically implanted transvaginally. It integrates with the surrounding tissue and is anchored to the muscles and ligaments surrounding the pelvic floor in order to support the organs above it.

The TVM patch is a permanent implant. It can shrink, erode, and embed itself into tissue over time, leading to severe pelvic or vaginal pain, infections, organ perforations, urinary problems, and difficult or painful sexual intercourse. Efforts to correct the problem can be expensive, difficult, and dangerous. Because the mesh is made to be permanent, it is often difficult or impossible for surgeons to remove all of it.

In July 2011, the FDA issued a statement advising that TVM complications are not rare, and that the mesh used in POP repair exposes patients to risks not present in traditional surgical repair. This notice was issued after 2,875 injuries related to the mesh were reported to the FDA between 2008 and 2010 alone. The reported complications include mesh devices from nine different manufacturers.

If you have suffered from TVM complications, you are not alone and Diamond Massong is here to assist. We are currently reviewing cases involving mesh made by American Medical Systems, C.R. Bard, Boston Scientific, Johnson & Johnson, Coloplast, and other manufacturers.

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Power Morcellation Surgery

First approved by the FDA in the mid-1990s, power morcellators are widely used in minimally invasive (laparoscopic) hysterectomies and fibroid-removal surgeries. These small bladed devices allow surgeons to cut the uterus or fibroid tissues into small parts so they can be easily extracted through laparoscopic suctioning. However, for women who may have undiagnosed cancer, there is a serious risk the device may spread cancerous cells inside the body. A new study published in a leading medical journal reaffirms a growing body of literature that suggests this danger is much worse than previously recognized.

In addition to spreading cancerous tissues known as uterine sarcomas hidden within fibroids throughout the abdominal cavity, power morcellation can cause the spread of even benign fibroid or uterine tissue throughout the abdomen and pelvic cavity, causing pain, infection, or bowel obstruction as the tissue adheres to and grows on other organs. The FDA’s Obstetrics and Gynecology Devices Advisory Committee recommends that power morcellation not be used on women who are peri- or post-menopausal with new or symptomatic fibroids or on women with a known or suspected malignancy.

Diamond Massong is currently investigating legal claims involving women who have received a cancer diagnosis or have required removal of fibroid tissue growing on other organs after undergoing a hysterectomy or fibroid removal surgery.

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For more information or to schedule an appointment, please contact us for a free consultation.

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