The Breast Chek™ Story

An amazing 22-year odyssey lies behind the development and marketing of the Breast Chek kit.

In an epic struggle, hurdle after hurdle had to be overcome on legal and marketing fronts, until the current success was achieved. A lengthy and costly battle with the FDA ultimately ended in victory only after national media exposure (Wall Street Journal, Good Housekeeping Magazine, etc.) and the intervention of members of congress. But even once this potentially life-saving product was finally cleared for over-the-counter sale there were several false steps and changes of brand name in the effort to get the Breast Chek kit into the hands of women everywhere.

It was not until Plexus Pink stepped into the picture in 2006 that the fortunes of the Breast Chek kit changed positively – and in a spectacular manner as this amazing device is now available on a global basis exclusively through a person-to-person marketing network of caring Plexus Pink independent agents.

1984

It all begins in late 1984 when inventor Don Perry of Decatur, Illinois comes up with the idea of a device that enhances the sense of touch. Quite simply, it consists of two sheets of sealed polyurethane with a special lubricant in between. Its effect, however, is quite dramatic: it greatly reduces the friction that occurs when fingers are moved over the skin. The result: greatly increased tactile sensitivity, making it possible for women to more effectively conduct breast self-exams.

1985

Early in 1985, Don teams up with a local firm of inventors, the Earl Wright Company, which in April applies for a patent for the “Touch Enhancing Pad.” The inventors are named as Donald A. Perry and H. Earl Wright. The patent is granted two years later in April of 1987. (CLICK HERE)

Upon submitting the product to the U.S. Food and Drug Administration (FDA) for clearance, the agency’s initial response was positive, but approval (at that time) was denied pending extensive labeling changes, including a “by prescription only” declaration, and the removal of all references to breast cancer.

1986

Marketing efforts comply with the FDA requirements and further studies are conducted. In one study at Millikin University, Decatur, 13 women perform exams on foam squares using both their bare hands and the device. The women are behind a curtain so they can’t see the squares. When using their bare hands they find large lumps in the foam 40 percent of the time. When they use the device the success rate jumps to 70 to 90 percent. For smaller lumps the percentages are 30 percent with their bare hands and 40 to 50 percent with the device. D. Rene Verry, Ph.D., reports, “Specifically, subjects were more accurate and took less time to find the lump when (Breast Chek) was used.”

Another study, conducted jointly by Springfield Memorial Hospital Cancer Center and Southern Illinois University School of Medicine, involved 200 women. Half are taught to do breast self-exams the “normal” way, half with the device. Nine months later a follow up study shows that 75 percent of the women using the device were continuing to do their self-exams in comparison to only 55 percent of the “normal” group. .

Nevertheless, the FDA requires the ‘pre-market approval’ to be completed in spite of the fact that the device poses no discernible direct risk to users. The FDA further requires exhaustive clinical tests of the device on women comparing the number of breast-cancer cases detected through self-examination with and without Breast Chek.

1987-1988

Upon completion, the FDA rules the trials as “insufficient”. Facing the prospect of starting redoing the expensive study, Don and Earl change course and begin to market the product under a new brand name—“Sensor Pad”—through a company called Inventive Products Inc. (IPI). Over a 15-month period 250,000 pads are sold to 200 hospitals.

1989

In April 1989, the creation of the “Touch Enhancing Device” wins Don Perry the award as “Outstanding American Inventor of 1989” and finalist in the inventor of the year contest staged by the Intellectual Property Owners Foundation. The winner that year was MRI (Magnetic Resonance Imaging). Interestingly, the fact that Breast Chek was a finalist for this prestigious award amongst such high-tech competitors as MRI (now a staple among diagnostic tools) speaks volumes as to the effectiveness of the device.

1990

On June 14th 1990, a U.S. district court in Danville, Illinois rules against the Earl Wright Company in favor of the FDA. The company appeals—reiterating its earlier argument that the device (then called the Sensor Pad) didn’t need to be classified because it is used only as a screening tool, not for diagnosis of disease.

1991

On February 25th, 1991 an appellate court in Chicago upholds the original ruling.

1992

In March 1992 Grant Wright (Earl’s son and president of IPI) files an ethics complaint with the FDA upon learning that FDA officials had met with a minority shareholder of his company without his knowledge. Letters fly between the FDA, the company, and Congressman John Dingell of Michigan, a known FDA critic who has been contacted by the company. Four months later the FDA says it is investigating the company for possible violations of federal law for selling the device in 1990-1991.

1994

The Wall Street Journal covers the story in its April 12, 1994 edition. Staff reporter Bent Bowers writes: “Though many doctors and cancer specialists hail the Sensor Pad as a useful tool in detecting the disease that many women fear most, and though it years ago sailed through approval processes in Europe and Asia, the Food and Drug Administration won’t let Inventive Products Inc. sell it in this country…What began as an FDA request for more information has degenerated into a long, debilitating struggle and allegations that the Wrights violated federal law.”

The WSJ quotes Susan Alpert, director of the FDA’s Office of Device Valuation as saying, “Their intention is very worthy. But the issue for the agency is of ensuring that we don’t allow to market any device that poses significant risk without an attendant benefit.” Meanwhile, it is reported that the FDA has a backlog of 5,000 applications for new medical devices and the average review time has stretched to 196 days. Inventive Products’ legal costs alone are estimated at $356,000. The company faces closure.

Later in the year the WSJ story is raised in Congress by Representative John Duncan of Tennessee and ABC’s 20/20 does an investigative report on the FDA highlighting the Sensor Pad saga and other examples of device delay.

In September an FDA Advisory Panel says that Inventive Products should do: a) simple laboratory tests using ordinary women to prove whether the Sensor Pad enhances touch b) A few months of having doctors-in-training feel the breasts of women about to undergo biopsies with and without the device to see if it enhances their exam and c) surveys on whether women perceive the device as an addition to or substitute for fingertip exams and, once the device is for sale, whether they abandon regular checkups.

 

1995

During 1995 the company produces the results of two new studies and the pace of congressional oversight intensifies.

One of the studies, conducted in the United States, examines the impact of different educational strategies on the skill and frequency of breast self-exams. The other study in Japan with 832 women shows that those who (had been properly instructed on use) detect their own breast lumps almost as frequently as they are found by trained nurses using the device. Nurses were able to detect lumps in each of the 72 women identified with breast cancer—only one woman missed finding her lump.

In November, testifying before a house subcommittee looking into FDA reforms, FDA director David Kessler, says: “With the benefit of hindsight we can say that if this product came into the agency today, we believe we would deal with the review differently….When the application first came to the agency there was heightened concern about the possibility of unforeseen effects of this seemingly simple device.” He also concedes that when “communications between the company and the review staff reached an impasse, (FDA) management failed to intervene as quickly as they should have.”

Congressman Richard Burr Republican of North Carolina, who serves on the subcommittee on FDA reforms, says: “To me this is not a medical device, and I don’t see why the company needs government permission to put it on the market.”

The result of all this scrutiny is that on December 22nd the FDA announces that it has cleared the Sensor Pad for marketing
(CLICK HERE)—but only through health care providers, clinics and “other institutions where women can receive the necessary instructions in its proper use.”

The Medical Device Manufacturers Association says that the clearance “was a way for the FDA to save face” after federal legislation introduced in two separate bills would have cleared the way for Sensor Pad sales as interstate commerce. The bills mandated 510(k) clearance for the device but did not distinguish whether to sell by prescription only or over-the-counter. At this stage Inventive Products is said to have spent more than $2.5 million in development costs during its 10-year regulatory entanglement.

Later in December, Nevada congresswoman Barbara Vucanovich, takes up the fight and writes to the chairman of the Subcommittee on Health and Environment requesting hearings on “Sensor Pad legislation…specifically on the importance of the over-the-counter availability” of the product.

She writes: “The Sensor Pad was invented for use as an aid to breast lump detection during self-examination. Unfortunately, the FDA has delayed approval of this device for ten years. In that time, millions of women throughout the United States have died from breast cancer. Deaths which might have been prevented, had the cancer been detected early.”

She adds, “Limiting availability to the Sensor Pad, which has been suggested by the FDA, will not help the millions of women who perform a breast self-examination each month….The Sensor Pad…can be helpful in educating women on the proper technique of self-detection of breast lumps…We must not endure the stalling tactics started by the FDA ten years ago.”

Vucanovich, a breast cancer survivor, introduces a bill to the House to exempt the Sensor Pad from FDA approval. Good Housekeeping magazine later quotes her as saying, “It’s ridiculous that the FDA is keeping this valuable device out of the hands of American women.” During hearings a number of women and doctors testify on behalf of the Sensor Pad.

1996

Good Housekeeping carries a major article in its February issue and reports, “The FDA’s stance has enraged many breast cancer activists, doctors, politicians and women. They say that with breast cancer reaching epidemic proportions…the FDA's failure to reach agreement with the company is inexcusable.“

It reports that the Sensor Pad had originally been placed in the category of Class III medical devices, the most stringent category reserved for life-supporting products or “those of substantial importance in preventing impairment of human health.” .

1997

One of the FDA’s requests was to prove that women could understand the instructions accompanying the device and that use of it would not discourage them from seeking routine mammograms. A study is conducted by Robert Hironimus-Wendt, a professor in the Department of Behavioral Sciences at Millikin University, Decatur, Illinois in which 68 women are surveyed and later followed up. Says Professor Hironimus-Wendt, “The study showed that women are actually more likely to receive follow-up exams after using the device... The impact of having a product on the market like this is huge in that women are going to be more likely to perform self-exams which can be life-saving in a number of cases.”

In October the FDA finally gives clearance for the aid to be sold over the counter—i.e. without a doctor’s prescription. It is reported that the FDA acted in part after prompting by Rep. Joe Barton, Republican of Texas and chairman of the House Commerce Committee’s oversight and investigations subcommittee held hearings on the delays in approving the product.

1999

The Wright family sells its half share of the patent to a major medical supply company, Don Perry retains his 50% share. As a result of Wright’s sale, Becton Dickinson, which launches the Sensor Pad under the brand name B-D Sensability Breast Self-Examination Aid (CLICK HERE) through drug stores and major chains nationwide. Retail efforts are a complete failure and all stock is removed from participating locations. Later, in 2003, Becton Dickinson attempts to sell their remaining stock for pennies on the dollar to MBF Sales, Inc. The offer is refused.

Becton Dickinson also develops its own glove-type version of the Breast Chek kit. Again, retail sales efforts generate dismal results.

2000

The Imaginis company launches the Aware BSE pad.

2001

On October 31st 2001 Don Perry signed a license agreement, under his patent, with Biomerica. November 5th Biomerica Inc., a medical technology company, announces its version—the Aware Breast Self-Examination Pad—with the goal of having it available for drugstores and doctors’ offices by the end of the first quarter of 2002. All retail efforts along those lines failed.

2002

On a business trip to Taiwan American entrepreneur Jim Goble discovers a version of the device and immediately recognizes its potential. The only problem: the people with whom he is dealing do not own the rights and upon returning to the USA Jim tracks down original inventor and patent holder Don Perry and acquires the rights from him.

Jim’s first attempt to market it is through a large network marketing company called Unicity. They enthusiastically place an initial order and the product moves briskly for two to three months while it is the center of attention. However, the company has 250 other products and distributors are actively encouraged to focus their energies there.

Meanwhile, Jim explores other marketing strategies and in November 2002 (as owner of MBF Sales LLC) receives FDA clearance to market the product (then called My Breast Friend Self-exam Pad), classified as a Class II Medical Device.

2003

Meanwhile, internationally acclaimed entertainer Olivia Newton-John, a breast cancer survivor, becomes interested in promoting the product and an agreement is struck. Olivia’s team rebrands the product the “Liv Kit” and puts together a marketing strategy involving a 30-minute TV infomercial and distribution through major retail outlets. It’s a strategy that seems to make sense.

On May 9, 2003 Jim Goble applies for a patent on a newly-designed version of the “Breast self-examination pad.” The patent is issued on March 22nd, 2005. (CLICK HERE)

2006

As a result of the extremely disappointing results via the direct sales and retail sales approaches exhausted by Olivia’s team, Jim Goble reacquires exclusive control of the product.

In October Jim together with business partner, Bill Brooksher, launches Plexus Pink a network marketing company with the primary mission of getting a Breast Chek kit into the hands of women throughout the world – an ambitious and exciting global undertaking.

2007

The Breast Chek kit finally hits the big time. A network of Plexus Pink independent agents dedicated to spreading the word about the need for early detection using the Breast Chek kit as a monthly aid proves to be THE WAY to market this potentially life-saving product. Within a matter of a few months independent agents enthusiastically adopt the mission in more than 20 counties with expansion continuing at a furious rate.

Sources: Wall St. Journal; New York Times; Good Housekeeping; Herald & Review Decatur; Fort Worth Star-Telegram; U.S. Patent Office; Food and Drug Administration; FDAReview.org; personal communications.