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The medical device manufacturer Smith & Nephew has received a warning letter from federal regulators over manufacturing practices at a Massachusetts plant that makes morcellators, which are controversial medical devices used during laparoscopic hysterectomy and uterine fibroid procedures that have been linked to a risk of spreading aggressive cancers.
An FDA warning letter was sent on April 30, which has led to the company placing a hold on its Truclear Ultra Reciprocating Morcellator 4.0, a disposable blade that attaches to the Truclear Hysteroscope 8.0.
According to the FDA, the company’s Andover, Massachusetts factory has quality control problems that the company has failed to address.
The letter said that the company has failed to meet current good manufacturing practice requirements. At issue are a number of reports the company received several years ago regarding loss of visualization with the morcellators. The FDA opened an investigation in September 2012, finding that the component was out of specification due to undersized sluff chambers.
In response, Smith & Nephew replied to the FDA with eight proposed corrective actions, however, the agency’s inspectors reviewed the corrective actions and found that they did not contain sufficient information to make certain that the actions were completed or verified as effective.
In addition, the FDA also found problems with sutures, and other medical devices made at the plant.
On April 15, Smith & Nephew informed the FDA that it was placing a hold on the morcellators made at the factory while it addressed the agency’s complaints and hopes to be able to verify the effectiveness of its corrective actions by January 2016. However, the FDA said the company has failed to provide enough information about what it intends to do, and has ordered the company to provide complete documentation of its corrective actions.
The company was given 15 days to respond to the letter regarding the steps it is taking to correct the problems. Failure to do so could result in the FDA taking further regulatory action such as seizure, injuction or imposing civil penalties.
Morcellator Cancer Concerns
Laparoscopic tissue morcellators are medical devices increasingly used in recent years to allow doctors to remove the uterus or uterine fibroids through a small incision in the abdomen, providing shorter recovery times and reduced risk of infection or other complications. However, over the past year, concerns have emerged over severe and potentially life threatening risks the devices may pose for women with occult or unsuspected sarcoma contained within their uterus.
In April 2014, the FDA announced that it was investigating the morcellation cancer risk, estimating that 1 out of every 350 women may have unsuspected sarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
In recent months, a growing number of women and families nationwide have been filing power morcellator cancer lawsuits against the manufacturers of these devices, alleging that inadequate warnings have ben provided for patients and the medical community for years.
Plaintiffs allege that the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.