FDA Recall: History, Details, and Aftermath

FDA Recall: History, Details, and Aftermath2018-09-18T15:49:18+00:00

In 2014, the Food and Drug Administration (FDA) issued two safety communications regarding the use of the power morcellator, a device that can potentially spread undiagnosed uterine cancer throughout the body.

In this way, an undetected early stage uterine cancer may develop to an advanced stage, which is difficult to treat and often results in a poor prognosis and severely shortened life expectancy, according to the National Health Society.

The FDA announcements have sparked public controversy, debate, and other events significant to the healthcare and legal fields, and to public health at large.

Power Morcellator History

The development of power morcellators arose as part of a larger trend towards alternatives to traditional open surgeries, which often leave large scars, cause a great deal of post-operative pain, and require a long recovery period.

Minimally-invasive surgeries, in theory and often in practice, reduce trauma to the patient by reducing the size of the incision(s) needed for operation, according to OB/GYN Dr. Marcelle Pick at Women to Women. A considerable challenge in such surgeries is providing enough room and visibility for surgeons to perform the necessary procedures.

A particular type of minimally-invasive operation called laparoscopic surgery is performed by using long, thin instruments inserted into the body via very small incisions.

For laparoscopic surgical removal of the uterus (hysterectomy) or uterine fibroids (myomectomy), there must be a way to cut up the tissue to be removed into fragments small enough to fit through the entry incisions. Power morcellators were developed for this purpose in the early 90’s and became widely used as the popularity of laparoscopic surgeries grew.

The first power morcellator was approved by the FDA through a process called 501(k) clearance, which presents a new device as safe based on supposed similarity to a device already on the market.  This process has come under intense criticism in recent years due to the power morcellator controversy.

Sad and distressed womanStudies on power morcellators performed in 2012 revealed that the device’s cutting mechanism, a set of spinning blades, can easily disperse tissue—and if the tissue is malignant, cancer can be seeded throughout the body.

A number of specific cases surfaced, a prominent one being that of Amy Reed, M.D., an anesthesiologist who, in October 2013, underwent a laparoscopic hysterectomy, which she had thought was a relatively safe and commonplace procedure. After the surgery, she found out that she had advanced stage uterine leiomyosarcoma, an especially aggressive and treatment-resistant form of cancer.

Alleging that power morcellators caused the upstaging of the undiagnosed cancer, Dr. Reed’s husband, Hooman Noorchashm, MD, PhD, a cardiothoracic surgeon, started campaigning fiercely for a ban on the devices in December 2013.

The FDA Announcements

In response to the campaign efforts by Dr. Noorchashm, public backlash involving the case, and the growing body of research indicating the dangers of power morcellators, the FDA issued two warnings regarding the use of power morcellators in 2014.

The April Announcement

The first FDA communication regarding power morcellators was dated April 17, 2014. It focused on several aspects of the power morcellator issue and was addressed to healthcare providers/facilities, cancer organizations, prospective uterine surgery patients, and device manufacturers.

As well as discouraging the use of power morcellators in general, the announcement especially warned doctors against using the devices in any case of suspected malignancy, as well as in cases of patients possessing risk factors for uterine cancer.

From recent data, the FDA estimated that 1 in 350 women receiving surgical treatment for uterine fibroids have undiagnosed uterine cancer, specifically, the more treatment-resistant sarcomas. This indicates a much greater risk than 1 in 10,000 women, the figure previously believed and cited to patients.

Doctors were urged to explore all alternative treatment options for uterine fibroids and to thoroughly inform patients of the possible risks of morcellation, and patients were encouraged to be proactive in requesting information.

The November Follow-Up Announcement

After reviewing more scientific literature and holding a meeting with the Obstetrics and Gynecological Medical Device Advisory Panel in July 2014, the FDA issued an updated warning. Dated November 24, 2014, this warning included a new kind of alert called an Immediately-In-Effect (IIE) guidance. This IIE guidance urged device manufacturers to include 2 contraindications for power morcellators and a boxed warning on the packaging of their power morcellator products.

The follow-up increased the scope of the warning about power morcellators, now advising against their use in the majority of patients needing surgical treatment for uterine fibroids. In addition to the previous estimate of the prevalence of unsuspected uterine cancer, this follow-up cited a figure specific for unsuspected uterine leiomycosarcoma—a prevalence of 1 in 498.

Did the FDA Recall Power Morcellators?

Though a complete ban is still under consideration, the FDA decided not to recall power morcellators in order to leave the option of using them open for certain women at low risk for uterine cancer.

Activists such as Dr. Reed and Dr. Noorchashm feel that the FDA should have taken more drastic measures against power morcellators.  However, the FDA recall and activist efforts did exert significant influence, spurring changes in relevant medical practices, policies, and legislature.

Johnson & Johnson Product Recalls

Shortly after the first FDA recall, Johnson and & Johnson, which dominates the market for power morcellators, stopped selling several of the models manufactured by its Ethicon division and later issued a worldwide recall of the devices.

Because of possible evidence that Johnson & Johnson may have known about the risks of morcellation as early as 2006, the manufacturing giant came under investigation by the FBI in early 2015.

Prohibitions from Hospitals

Hospitals such as Temple University Hospital and Brigham and Women’s Hospital (which is the location where Dr. Reed had her laparoscopic operation) had already restricted the use of power morcellators, prohibiting them to be used without containment bags, in early 2014.

After the FDA recall, a major national hospital chain, HCA Holdings Inc., stopped using power morcellators altogether.

Discontinuation of Insurance Coverage

After several smaller insurance companies such as Blue Shield of California and Highmark, Inc. enacted policies excluding coverage for surgeries employing power morcellation, major insurance companies such as Aetna (in May 2015) and Health Care Service Corp (in June 2015) began to follow suit.

Medical Device Legislation

After speaking with Dr. Reed and Dr. Noorchashm about their tragic experience, Pennsylvania Representative Mike Fitzpatrick and Senator Robert Casey put pressure on the FDA regarding their response to the possible risks of power morcellators.

Rep. Fitzpatrick and other lawmakers also fought to pass several amendments concerning the legislative processes governing the approval, monitoring, and tracking of medical devices such as power morcellators. The only one of these amendments that passed requires precise tracking of high-risk device use via electronic health records.

The Future

The public discourse regarding power morcellators is ongoing and new developments are constantly taking place.

The FDA continues to consider whether power morcellators should remain on the market. Device manufacturers and medical researchers seek to find ways to modify the device design to reduce its risk, such as including a containment bag that is durable and allows for visibility.

Patients and families of patients who were adversely affected by power morcellators continue to come forth with lawsuits against device manufacturers and/or medical practitioners to fight for justice and compensation for their suffering.

If you or someone close to you may have been adversely affected by power morcellators, the personal injury lawyers at Banville Law can help you assess your legal options.

Further Reading