More Than 41,000 Injuries Reported From Surgical Staplers

In March 2019, the FDA announced that it received over 41,000 adverse event reports associated with surgical staplers and internal staples. These reports may cause the FDA to assign a stricter product classification for the devices.

What’s the Problem?

The adverse event reports come from January 2011 to March 2018. Over the span of seven years, about 9,000 serious injuries, 32,000 malfunctions, and 366 deaths have been reported. However, there are also “many more” surgical stapler and internal staple malfunction reports that are inaccessible to the public.

The most commonly reported problems are:

  • Rupture of the staple line or malformation of staples
  • Misfiring, difficulty in firing, or failure of the stapler to fire the staple
  • The application of staples to the wrong tissue or using the wrong staple size

These problems can lead to:

  • Bleeding
  • Sepsis
  • Tearing of internal tissues and organs
  • Increased risk of cancer recurrence
  • Death

What’s the FDA Doing About This?

The FDA sent a letter to healthcare practitioners outlining several safety recommendations for the use of surgical staplers. The FDA plans to hold a public meeting to discuss whether to reclassify surgical staplers as Class II medical devices. A Class II medical device is the strictest classification. This would allow the FDA to establish mandatory controls to help mitigate the known risks of the surgical staplers.

Contact Us

If you or a loved one experienced a severe injury from a surgical stapler or internal staples, please contact GoldenbergLaw. We deliver the Gold standard advocacy you deserve.

Partner Laura Pittner Appointed to PSC in Zimmer M/L Taper Hip MDL

GoldenbergLaw Partner Laura Pittner has been appointed to the Plaintiffs’ Steering Committee (PSC) in the Zimmer M/L Taper hip Multidistrict Litigation (MDL). This occurred on December 14, 2018, by the Hon. Jesse M. Furman, United States District Judge for the Southern District of New York.

About Laura PittnerPartner Laura Pittner

Laura has extensive experience in hip device litigations and has led GoldenbergLaw’s defective hip practice in the Depuy ASR, Depuy Pinnacle, Biomet M2A, Wright Profemur, Conserve and Dynasty Hip Systems, Zimmer Durom Cup, Smith & Nephew Birmingham Hip, Stryker Rejuvenate, and Stryker LFIT V40 cases. Her leadership has resulted in millions of dollars of settlements recovered for our clients.

Laura has also helped in the leadership of several other mass torts litigations, including in Benicar, a heart pressure medication alleged to cause gastrointestinal injuries, and Farxiga, a diabetes drug alleged to cause serious diabetic ketoacidosis.

Laura has been with GoldenbergLaw since 2010. She is a knowledgeable leader in mass tort and product liability cases. In addition, her practice includes motor vehicle, chemical exposure, and premises liability cases. She is also the proud mother of twin boys Cecil and Odin.

Zimmer M/L Taper Hip Prosthesis and Versys Femoral Heads

The Zimmer M/L Taper and Kinectiv hip systems are comprised of the femoral components of an artificial hip device. The devices are designed to be made of up two pieces, the neck and stem, not dissimilar to the Stryker Rejuvenate hip device that was previously the subject of consolidated litigations that resulted in substantial settlements. While the Zimmer M/L devices have not yet been recalled, there have been several reports of early failure associated with corrosion and metal wear at the neck-stem interface requiring revision.

In December 2017, a verdict was secured against Zimmer, the maker of the M/L Taper device in a case tried by another law firm in New Mexico. The plaintiff in that case was awarded over $2,000,000.

Several M/L Taper cases have been filed in various state and federal courts across the country. In October 2018, the Judicial Panel of Multidistrict Litigation ordered that Zimmer M/L Taper cases throughout the United States be consolidated in the Southern District of New York before the Honorable Paul Crotty. The first case management conference occurred on December 6, 2018. At that time, the proposed Plaintiffs’ leadership committee was approved.

Contact Us

GoldenbergLaw is currently investigating Zimmer M/L Taper cases and other defective hip replacement cases. If you or a loved one has been fitted with a defective hip replacement, contact GoldenbergLaw.

Some Vaginal Rejuvenation Treatments Being Illegally Marketed, FDA Says

On July 30, 2018, the FDA released a safety announcement warning several companies to stop marketing their devices for vaginal rejuvenation procedures. The FDA is claiming they are “dangerous and deceptive treatments.” While the lasers and other energy-related procedures were intended for and approved to treat conditions like cancer and genital warts, manufacturers began to market the devices for symptoms related to vaginal rejuvenation procedures, such as vaginal atrophy, menopause, urinary incontinence, and sexual function.

What Is the Problem?

These manufacturers are illegally and deceptively marketing these lasers to be used for procedures that were never approved by the FDA. Any medical device or drug not approved by the FDA can be used off-label by a medical professional. However, the manufacturers of the device or drug cannot promote it off-label.

The FDA sent letters to several manufacturers regarding this off-label promotion. In some cases, the FDA even quoted the content on manufacturers’ websites that had false information. For example, BTL Industries, Inc. marketed the Exilis (Exilis Ultra 360), a radio frequency treatment, with “the Exilis Ultra 360 system is proven to increase elastin and collagen in the treatment area,” referring to vaginal rejuvenation procedures. The Exilis Ultra 360 was not approved for vaginal rejuvenation procedures, but rather for dermatology, including wrinkle treatment. BTL has removed the Exilis Ultra 360 page from their site following the FDA’s notice.

What Are the Injuries?

There have been 14 adverse events reported, including vaginal burns, scarring, and extreme pain following the procedure. Vaginal rejuvenation procedures can also cause bleeding, infection, adhesions, and numbness or loss of sensation.

What Are the Types of Vaginal Rejuvenation?

Vaginal rejuvenation surgery can have other names, including:

  • Cosmetic gynecology
  • Female genital plastic surgery
  • Female genital rejuvenation surgery
  • Re-virgination
  • G-spot amplification
  • Vulvovaginal plastic surgery
  • Designer vagina surgery

Who Are the Defendants?

The FDA sent letters to Immode, Sciton, Alma Lasers, Thermigen, BTL Aesthetics, BTL Industries, and Cynosure because of their deceptive advertising. The American College of Obstetricians and Gynecologists issued a statement that advises obstetrician-gynecologists and patients to be cautious with these procedures, as they are not approved by the FDA for the treatments they are being marketed for.

GoldenbergLaw Can Help

If you or a loved one underwent a vaginal rejuvenation procedure and experienced a serious side effect, contact GoldenbergLaw immediately. Our defective medical device lawyers have over 30 years of experience and are national leaders.

 

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