December 2011 e-Newsletter

Warning about surgical mesh for pelvic organ prolapse repair

Are you or is anyone you know planning to have surgery for the repair of pelvic organ prolapse? If so, then you must read this about the warning from the FDA and the American Congress of Ob/Gyn (ACOG) about the dangers and risks of surgical mesh used to help repair these conditions.

Pelvic organ prolapse includes disorders such as the bladder bulging into or outside the vagina (called a cystocele) or the rectum doing the same (called a rectocele). For more than 50 years gynecology surgeons have been repairing these problems without using anything more than surgical instruments and sutures.

However, in the past 5-10 years, the use of permanent surgically implanted mesh is growing, and this mesh is causing many serious and devastating complications such as infections that will not heal, severe and chronic pain and the mesh is even breaking through the vaginal wall (erosion) causing pain, bleeding and a malodorous vaginal discharge.

For every mesh complication, the patient is likely to need a risky surgery to attempt removal of the mesh. These operations are fraught with danger since the mesh scars down and attaches to the surrounding tissues. Attempted surgical removal of the mesh can also lead to damage to adjacent organs such as the bladder or the rectum and the patient might even end up with a colostomy.

How did we get into this situation?

This is because these mesh products are FDA approved for use in humans in many cases with absolutely no safety data on their use in people. Sometimes the mesh is only studied in animals. Since mesh has been safely used for years for hernia repairs, the manufacturers basically assumed that their products would be safe in the vaginal area.

Well, they assumed wrong.

According to ACOG, in their December 2011, Committee Opinion, Number 513

"…There seems to be a small but significant group of patients who experience permanent and life-altering sequelae [consequences], including pain and dyspareunia [painful intercourse], from the use of vaginal mesh.”

The number of studies on patients who have had mesh placement are few. In one study, “there was a higher rate of complications associated with vaginal mesh compared with native tissue vaginal repairs, including a 10% mesh erosion rate.” Ten percent of patients developed mesh that eroded right through their vaginal wall. In other studies the rate was as high as 20%!

The FDA has sent a warning to Ob/Gyn offices

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP [pelvic organ prolapse] are not rare.”

In its 2011 Safety Communication, the FDA identified vaginal placement of surgical mesh for pelvic organ prolapse repair as an area of “continuing serious concern”. The FDA recommends that clinicians inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, vaginal scarring, and narrowing of the vaginal wall in pelvic organ prolapse repair using surgical mesh, and doctors should provide a copy of the patient labeling from the surgical mesh manufacturer if available.

Better yet, find an experienced Gyn surgeon who can perform this operation safely without the use of mesh at all.

*****

New Technology Finds Breast Cancers that are Missed on Mammogram

It is widely believed that routine mammography will detect breast cancer if it is there to be found. Unfortunately, this is far from the truth. It is well known to medical professionals and radiologists that mammograms can miss up to 20% of cancers that are in the breast waiting to be found. In fact, women with a palpable cancerous lump can sometimes have a normal mammogram! Why does this happen?

There are many reasons for missing a cancer on mammogram. It might be too small to see. It might be obscured by implants or scar tissue. It might not show any of the changes that are looked for (abnormal calcium deposits are suspicious for cancer but are not always present).

But the single most common reason for a mammogram to miss a breast cancer is that many women have dense breast tissue and the density of the tissue hides the typical findings radiologists use to detect cancer when they read a mammogram.

Awareness of the problem of breast tissue density is growing.

The web site, www.areyoudense.org is dedicated to increasing public awareness of this issue. The awareness of this problem has reached the Federal Government. On October 5, 2011, HR 3102 legislation was introduced that would require all mammograms to report on the patient’s breast density and to inform the patient with dense breast tissue that they might benefit from additional screening tests. In California, Governor Brown recently vetoed SB 791 which said the same thing. This bill passed both the California House and the Senate and is expected to be reintroduced and pass in 2012.

What additional tests can help detect breast cancer in a woman with dense breast tissue?

Many people turn to MRI for these situations, but MRI can cost up to $2,000 every time and is often not covered by insurance, leading to a big battle between the worried patient and their health plan.

Luckily, there is another alternative, called SonoCiné AWBU. The AWBU stands for “Automated Whole Breast Ultrasound.” To quote the company, “SonoCiné is an automated breast ultrasound system that has been cleared by the FDA as an adjunctive examination to mammography. It is a complementary examination and not a replacement for mammography. Peer reviewed, published, clinical trials demonstrated that SonoCiné, when used as an adjunct to mammography, found more and smaller cancers than were found by mammography alone.”

The inventor of SonoCiné AWBU is Dr. Kevin Kelly, a breast radiologist for over 30 years. He used to be on staff here at Huntington Memorial Hospital and Hill Breast Center. He left in order to commit full-time to bringing SonoCiné AWBU to market, and his dream is starting to come true. There are over 20 locations in the U.S. currently offering SonoCiné AWBU and it is being performed in other countries as well. They have over 30 patents on this technology so far, and it only costs about $300. Painless, quick, safe and with the ability to find breast cancers that mammograms will miss. Amazing!

You can schedule a SonoCiné AWBU with
Dr. Kelly himself. He is located in Venice Beach, less than an hour drive from Pasadena.
Call 310-566-6688

For more information, go to http://www.sonocine.com/.