Morcellation

In 1998 a subsidiary of Johnson & Johnson, the world’s largest medical device manufacturer, called Ethicon started manufacturing these devices.  They came out with three different models that have been on the market for many years.  The Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma are the most widely used power morcellators.  They account for a significant portion of the procedures that are performed on women.

In 2012 a study was published on the PLOS ONE website.  It showed that these devices, while they did a great job at minimizing damage to surrounding tissue, they were actually causing the spread of cancerous cells around the abdomen.  In fact, the dangers of having cancer spread were 9 times greater than previously stated.

Johnson & Johnson responded to the warning from the FDA by pulling their Gynecare Morcellator, and their Morcellex Sigma from the shelves.  They did not, however, issue a recall for any devices that were already in hospitals across the country.  They stated that they will keep the devices off the market until “their role is better understood and redefined by the medical community.”

Using a Gynecare morcellator is easier for the surgeon, allows the patient to recover in just 2 weeks instead of 8, and has many other benefits.  Unfortunately the risks of spreading cancerous cells, those which may not even be known until it is too late, is far greater than the manufacturing companies ever acknowledged.

In 1992 Lumenis Incorporated opened its doors.  Located in Salt Lake City this medical device company makes products for the aesthetic, surgical, and ophthalmological communities.  They have over 200 patents and have been a leading developer of medical devices for many years.

While the company is prevalent in the medical community, it is not a giant corporation like many of its competitors.  Holding a market cap of almost $550 million puts it at the lower end of the range.  But that is not to say they are small.  In the first quarter of 2014 the company posted earnings of over $65 million, an increase of almost 10% from the year before.

Many of these earnings came from the sales of their power morcellation device, the VersaCut.  This device acts just like the other devices and is used to remove fibroids in the uterus that are bothering the patient.  Since its initial approval in 2005, the device has been used to perform surgery on thousands of women in hopes of shortening recovery times.

Unfortunately, what happens in a good portion of women who have their surgery performed with a VersaCut morcellator is that cancer spreads throughout the uterus or abdomen region.  When the morcellator chops and grinds the tissue, some of it is spread through the area.  If this tissue contained cancerous cells, then that cancer is “seeded” around the area.  The seeded cancer then starts to grow aggressively, and the patient can go from no cancer symptoms, to an advanced stage of cancer in just a matter of days.

Hologic, a company dedicated to designing and manufacturing medical devices for women’s health, was founded nearly 30 years ago in 1986.  Since then they have grown and expanded to become one of the leading device manufacturers in the country.  The company sees massive sales, with revenue for 2013 at nearly $2.5 billion.  Their device MyoSure is one of the top selling morcellators on the market today and has greatly helped to bolster sales in this company that has a market cap of almost $6 billion.

The MyoSure morcellation device was approved for use in 2009.  This thin tube is inserted through the dilated cervix, where it can then be used to remove fibroids and polyps.  Because the device is so small, and it is not used for total uterus removal, there is no surgery required, not even a small incision.  Due to this fact, the manufacturers can brag a very rapid recovery rate.

While this device may be better at removing the tissue, and even though the MyoSure website boasts that nearly 100% of the tissue is removed every time, there is always some that is left behind.  When a power morcellator is used, the tissue is ground up and removed from the body.  When this happens some is left and some is scattered through the uterus.  If there are cancerous cells in the tissue that is left behind or scattered, it can spread the cancer to other areas of the uterus.  When spread, the cancer begins to aggressively grow and a patient can go from no cancer symptoms, to an advanced stage in a short period of time.

Nearly 150 years ago London, England saw the founding of the medical equipment manufacturer Smith & Nephew.  This medical giant has since expanded to countries around the world, and accumulated a massive stockpile of assets.  Their current market cap is over $15 billion and the first quarter of 2014 saw revenues coming in that were more than $1 billion.  These earnings were helped by their product, the TruClear Hysteroscopic Morcellator.

The TruClear Morcellator system initially found FDA approval in 2011.  With a tube diameter of just 5mm, the device can easily be inserted through the cervix to access the uterus; it is currently the smallest morcellator available.  While the manufacturer boasts that there is no tissue floating in the uterine cavity due to continues outflow and suction, it has been found that all morcellators leave behind some particles.

These tissue particles may end up causing no harm to the patient.  However, it has been found that 1 in 350 women have unsuspected leiomyosarcoma.  That is, they have cancerous fibroids that have yet to be diagnosed as cancerous.  If these fibroids are chopped and removed, the cancerous cells can be seeded throughout the area.  This seeding causes the cancer to spread and grow much faster than if it were left alone.  The result is that the patient finds them very quickly suffering from an advanced stage of cancer, and they are faced with the prognosis that their long-term survival outlook is bleak.

The first power morcellator found FDA approval nearly 20 years ago.  In the spring of 1995, this simple tool was granted approval through the FDA’s 510(k) process (that is, the process for approving medical devices).  Since that time many more devices have found FDA approval.  There are currently 15 top selling devices out there that are still in use in hospitals around the country.

The device has not been “disapproved” for use; however recent research has led the FDA to announce that they now discourage the use of these devices.  In April, 2014 the FDA concluded that the devices were not entirely safe for the use of hysterectomies or myomectomies (removal of uterine fibroids).

This statement came following a shocking discovery.  Research that was published on PLOS ONE in late 2012 showed that women were put at much more risk when a morcellator was used during their surgery than if a traditional open belly operation was performed.  This research showed that the rate of unexpected sarcoma (a type of cancer) was actually 9 times more likely than previously stated.

Johnson & Johnson’s subsidiary Ethicon has manufactured and sold 3 different morcellators.  On the heels of this announcement from the FDA J&J has announced that they will cease the sales of their devices.

The company, however, does not indicate any plans for a recall of the devices already in use; a troubling idea for morcellation critics.  The giant corporation does not plan to sell anymore, but they are leaving the devices out there to be used over and again despite the high rate of spreading cancer.

In late 2012 Brenda was having trouble with fibroids hemorrhaging.  Her doctor performed a routine myomectomy, and in the process removed a tumor that was in the low stages of cancer growth.  However, during the morcellation process the cancer cells spread, and has caused Brenda’s cancer to leap to an advanced stage of development.  Her suit against Ethicon (a branch of Johnson & Johnson) is ongoing.

Dr. Reed went in for a routine hysterectomy via morcellation.  As a busy professional with a large family, Dr. Reed was relying on the shortened recovery time with a minimally invasive surgery.  However, after her surgery she was informed that she had uterine leiomyosarcomas, and the morcellation process may have spread the cancer around her abdomen.

Amy Reed was an anesthesiologist at a prominent hospital in Boston.  At 40 years old she was just taking off in her career, making a name for herself by treating the Boston Marathon bomber.  In October 2013 Amy had given birth to 6 children, and her uterus was acting up.  Undergoing what she thought would be a routine surgery has forced her to battle for her life.

During and after childbirth uterine fibroids can act up.  These mostly benign tumors are usually just uncomfortable and rarely life threatening.  This spurs many thousands of women to undergo a non-medically essential hysterectomy.  During Amy’s laparoscopic hysterectomy it was discovered that she had leiomyosarcoma, a malignant cancerous fibroid.

Amy’s procedure was performed with the use of a power morcellator.  This device grinds up the tissue and extracts it through a small tube in order to keep the surgery as minimally invasive as possible.  However, when grinding a cancerous tumor the cells can be spread through the abdomen region.  This causes the cancer to grow much more rapidly and spread much more easily than if the tumor were removed intact.

Amy is now facing up to an 80% chance that her cancer has spread; as opposed to a 30% chance of it spreading had a morcellator not been used.  She is currently undergoing chemotherapy, and has stage 4 cancer.  Her prognosis is that she will most likely pass away within 5 years.  She and her husband are petitioning to have morcellation removed as an option until a safer method can be maintained.

You can read more about Amy Reed and her battle on the Wall Street Journal Website.

Scott has filed a negligence and wrongful-death suit against Ethicon, Blue Endo, and LiNA Medical after his wife Donna passed away from metastatic leiomysarcoma.  Donna went in for a routine hysterectomy in March 2012 with no signs of cancer.  However, just nine days later she was diagnosed with the cancer that ultimately took her life in February 2013, not even one year after the surgery.