Phony Breast Developer Hit by Court Action

Stephen Barrett, M.D.

The Iowa Attorney General has obtained a permanent injunction barring New Womyn and its president Dan Kaiser, from marketing their "Stimulations VII" vacuum device within or from the State of Iowa and is asking the court to order the defendants to reimburse purchasers and impose a civil penalty. In March 2001, the Iowa District Court for Polk County issued an injunction after the defendants refused to comply with an investigative demand for customer lists and evidence that the device worked as advertised [1]. In December 2001, the Judge made the injunction permanent [2]. The State's action was taken in response to claims that the device:

The Attorney General also charged that the conditions of a refund guarantee "are so onerous as to make the money-back guarantee illusory or worthless." [1] The case was triggered by a complaint of a young California woman who was seeking a refund of over $2,000. The suit said the company's "18-month money-back guarantee" didn't mean a refund was available for 18 months, but that consumers needed to use the device for 18 months, visit a physician every month, and fulfill many other conditions before they could obtain a refund [1].

Analysis of the Claims

The patent for Kaiser's device describes it this way:

An apparatus and method for enlargement of soft tissue, such as breast, including a vessel or dome configured to fit over the tissue which is to be enhanced or enlarged. The dome or vessel has a sealing cushion of elastic material which surrounds and encompasses the perimeter of the base of the vessel. The cushion includes a fluid compartment which is compressible. The fluid compartment is deformable such that when the vacuum is applied to the sphere, the seal material and compartment deform, isolate, and diffuse the pressure on the skin. The apparatus also includes a vacuum pump with a power source, a pressure sensor to regulate the pressure, or vacuum provided by the pump. The dome also includes a valve mechanism for controlling the ingress and egress of the vacuum to the interior of the dome. This valve will automatically close so that the pump may be removed from the dome and the pressure or vacuum therein be maintained. This valve also includes a release mechanism to remove or exhaust the vacuum in case of discomfort or emergency. The domes may also have different configurations, including rectangular, though normally they will remain as a sphere to maximize and equalize the augmentation of the flesh or tissue within the confines of the dome. The dome also is formed with a footed rim which is embedded in a deformable elastic cushion with a fluid pocket to augment the deformation and consequent reduction in the per square inch pressure applied to the tissue of the wearer [3].

In other words, the device fits over the breast and applies suction to the skin.

I served as an expert witness in the case. On November 19, 2001, at a hearing on its merits, an affidavit I had prepared was admitted into evidence [4] and I testified that the device was not recognized by experts as safe and effective for its intended purpose. My affidavit stated (in part):

13. Many pills, potions, creams, and devices have been claimed to enlarge the breast. To date, no product marketed for this purpose has been demonstrated to work as advertised. If a device could actually regrow a removed organ or section of the body, the inventor would make headlines everywhere, win the Nobel Prize in Medicine, and become a billionaire.

14. It is a basic principle of science that extraordinary claims require extraordinary evidence. For this reason, testing of an alleged breast-enlargement product should include many safeguards to ensure that any "before and after" differences are due neither to chance nor to other factors such as observer bias, variability of body weight, measurement variations, postural variations, and variability or shifting of body fluid content. The design features that should be considered include:

(a) The measurement process should be properly standardized, recorded, and judged. Standardization would involve determining how breast size can be reliably measured. The measurements must be made in the same way each person each time. All measurements should be made at the same time of day. The measuring tape or other instrument must be applied with the same tension each time. The individual's posture and position should not vary. Since chest circumference changes when people breathe in and out, the measurement should take place at the same phase of the respiratory cycle. The measurements should be recorded, and the process should be documented with videotapes and/or photographs.

(b) Water retention and excretion can cause weight to fluctuate throughout each day and also in connection with the menstrual cycle. Measurements should be made often enough to detect and compensate for any such variation. Frequent measurements would be desirable for this purpose-daily at first and later biweekly.

(c) Lifestyle changes should be recorded. Since overall fat-reduction through dieting and exercise can influence breast size, weight should be monitored and the extent of diet and exercise should be recorded.

(d) The experiment should be long enough to be meaningful. To document a claim that breast enlargement is likely to be permanent, several years of follow-up study would be needed.

(e) Observer bias could result in deliberate or unknowing measurement variations. For this reason, the observers should not know whether or not the people they measure are using the product. Further blinding can take place by preventing the observer from seeing the identity of the subjects they measure.

15. The claim of regrowth of a removed breast is so extraordinary that it would not be credible unless witnessed and photographed by several independent observers, with safeguards against fraud.

16. I have reviewed Patent #6,042,537 issued on March 28, 2000, to Daniel Kaiser and do not find it persuasive. The concepts it discusses are largely based on other tissues and don't apply to the breast. The document does not describe any experiments in which Mr. Kaiser's apparatus or a similar device was found to influence breast size. It merely claims that when human cells are sufficiently stressed, they will increase in size and their external structure will also deviate to accommodate any vacuum or negative force applied to the cell. Even assuming that this is true of cells, it would be irrelevant to use of Mr. Kaiser's Stimulations VII.

17. Applying a vacuum to the outside of the breast might slightly stretch tissue on the surface, but it will not change the shape of cells below the skin. Stretching tissue can cause fluid build-up, similar to what happens with hormonal change during the menstrual cycle. A device might temporarily stretch the skin of the breast, but in order to achieve true enlargement, the glandular and fatty tissue inside must increase. This can only occur with cell growth in either number or size. Glands grow in response to hormones. There is no preferential way to grow fatty tissue in this location. Growth of fibrous tissue does not enlarge the breasts. I don't see how a vacuum device would result in long-term changes to the breast that will increase its size. There may be some short-term changes in the skin, but they are unlikely to be permanent.

Penalties Upheld

After further proceedings, the lower court assessed a civil penalty of $40,000 plus $50,000 for attorneys fees and investigative costs, and ordered restitution that could amount more than $300,000 if all the people in Iowa requested refunds. Kaiser appealed, but in May 2004, the Iowa Supreme Court upheld the injunction and penalty. Although the Iowa action does not prohibit Kaiser from marketing in other states, I see no current indication that he is doing this.

References

  1. Consumer Protection Division sues Bettendorf marketers of "breast-enlargement" device. News release. Iowa Attorney General, Jan 11, 2000, updated March 8, 2001.
  2. Pille G. Findings, conclusons, and order. State of Iowa vs New Womyn, Inc, and Dan Kaiser, Equity No. CE-39318, filed Jan 7, 2002.
  3. Kaiser D. Method and apparatus for tissue enlargement. Patent #6,042,537, March 28, 2000.
  4. Barrett S. Affidavit in State of Iowa vs New Womyn, Inc, and Dan Kaiser, Equity No. CE-39318, Dec 18, 2000.
  5. Decision. State of Iowa vs. New Womyn, Inc., and Dan Kaiser, Supreme Court of Iowa No. 39/02-1049, filed May 12, 2004.

This article was revised on August 11, 2004.