Implant~Info~Net

The facts are:

 The manufacturers' own documents reveal a calculated cover-up and campaign of deceit on the safety of silicone implants.
They have refused to comply with the law requiring them to prove that implants are safe and effective. Women were told that this product would last a lifetime, but the rupture rate is extraordinarily high. About 100,000 women have manifested illnesses, with the common link being that they all have silicone breast implants. Two recent studies could not disprove the link between silicone implants and diseases such as lupus and rheumatoid arthritis. The studies failed to ask women uniform questions and failed to employ standard laboratory testing.

Manufacturers have Known for Years that Leaking Silicone Poses Health Hazards

Dow Corning, the leading manufacturer of implants, ignored doctors' complaints about leaking implants for years. A 1975 Dow Corning memo states that demonstration implants were "bleeding" and instructed sales staff to wash such implants with soap and water and towel dry before letting doctors handle them.

A 1977 memo relates how a Dow Corning employee told plastic surgeons "with crossed fingers, that Dow Corning too had an active contracture/gel migration study underway. This apparently satisfied them for the moment, but one of these days they will be asking us for the results of our studies." In fact, Dow Corning was not studying contracture, a complication that occurs when the scar around the implant contracts.

In 1983, Dow Corning's Head of Biomaterial Safety wrote top company management: "However, I want to emphasize that to my knowledge, we have no valid long-term implant data to substantiate the safety of gels for long-term implant use." This statement was made 21 years after Dow Corning first put silicone implants on the market and assured women that implants were safe.

In a 1987 study, the Medtox Project Report, Dow Corning acknowledged that the chronic reactions to silicone seen in test animals could trigger auto-immune-type diseases in humans.

In a Bristol-Myers Squibb document from 1985, a company employee states: "Polyurethane has no real history of implantation without deterioration and we know deterioration products of polyurethane are toxic and in some cases carcinogenic. Whether they are released in such low levels as to be no threat to the human body -- time will tell."

A 3M document from 1976 states that "It appears virtually no
documented safety and efficacy data exist on [Don McGhan's] implant products." McGhan's breast implant company, McGhan Medical Corp., was purchased by 3M.

Manufacturers Refuse to Comply with the Law

Dr. David Kessler, commissioner of the Food and Drug Administration, reiterated in testimony before Congress in August 1995 that "the law requires manufacturers to prove affirmatively, with valid scientific data evaluated by FDA, that their devices are safe and effective." Why have the manufacturers consistently failed to comply?

Dr. Kessler wrote in the Journal of the American Medical Association in 1993 that "the adverse effects data on silicone gel implants submitted by the manufacturers were so poor that the FDA could not determine whether these devices were safe and effective." He added that the manufacturers' documents suggested that there were inadequate quality control procedures to prevent safety problems and
that problems had been evident for years.

Breast Implants have an Extremely High Rupture Rate, and thus are Defective

Manufacturers told women that implants would last a lifetime and that ruptures occurred less than 1 percent of the time. But studies published in the American Journal of Radiology in 1992 and the Annals of Plastic Surgery in 1995 reveal a rupture rate of 5 to 51 percent. A third study, published in Plastic and Reconstructive Surgery in 1993, ties rupture to the age of the implant. Of implants aged one to nine years, 35.7 percent had ruptured. Of those aged 10 to 17 years, 95.7 percent had ruptured.

FDA Commissioner Kessler wrote in the Journal of the American Medical Association in 1993 that: "Even with a conservative rupture rate of 5 percent, some 75,000 of the estimated 1 to 2 million women with implants would be at risk for potentially serious adverse health effects. That is not a safety standard that the FDA can accept."

Thousands of Women Suffering Illnesses Constitute more than 'Anecdotes'

Dr. Kessler of FDA states that studies have shown that silicone gel is a potent stimulant to the immune system and could generate antibodies that attack collagen, a component of connective tissue. In 1992, the FDA received more than 23,000 reports of problems with implants, including complaints of "bleeding" implants, connective tissue disorders that could lead to arthritis-like pain and swelling in the joints, fibrous tissue spreading around the implants, and swelling of skin and limbs.

Steven R. Weiner, associate professor of medicine at the University of California at Los Angeles, asserted in August 1994 that once you see these women, that's all it takes to be convinced silicone implants can make them sick .... There's no one who has seen a large number of these women who disagrees."

Safety concerns prompted France in May 1995 to halt the importation, manufacture, sale or use of silicone-gel breast implants. In May, the Ministry of Health stated that implants filled with any product other than physiologic saline could rupture and "result in grave danger." France will not allow implants back on the market "until they have been definitely shown without risk to the user."

Two recent studies are fatally flawed

One of the most-cited papers used to criticize the link between silicone implants and connective tissue diseases suffers from fundamental flaws. The "Mayo Clinic" study published in June 1994

(1) failed to ask women uniform questions or employ standard laboratory testing;

(2) failed to look for the "atypical" signs and symptoms suffered by women with silicone poisoning;

(3) admitted that the control group (749 women with implants and 1,498 without) was insufficient and that an accurate study would require 62,000 women with implants and 124,000 without over 10 years;

(4) suggested an implant failure rate in excess of 30 percent (of the 749 women with implants, 257 had surgical revisions); and

(5) concluded that "No statistically valid conclusions can be drawn from this study."

Further, the study is at least subject to question since it was
financed in part by the Plastic Surgery Educational Foundation, the educational arm of the American Society of Plastic and Reconstructive Surgeons. This group has been given hundreds of thousands of dollars for research by implant manufacturers.

A study published in June 1995 -- the "Harvard" study -- suffers from similar flaws. Specifically, it
(1) failed to ask women uniform questions or use standard laboratory testing;

(2) failed to look for signs of "atypical" connective-tissue diseases, the symptoms of which do not fall into any clear diagnostic category;

(3) studied
too few women with breast implants (1,183 women with implants, 876 of which were silicone gel filled); and (4) failed to account for the fact that women with silicone implants may not manifest illnesses during the first eight years after implantation.

Further, as with the Mayo Clinic study, author bias is at issue. Two authors of the Harvard study have admitted under threat of perjury that they are paid consultants to breast implant makers. Also, Dow Corning has donated $5 million to Boston's Brigham and Women's Hospital, which played a key role in this study. source:www.siegfriedandjensen.co...lants.html

 Breast Implants and Your Health

Women with silicone implants have reported a number of different health complications. General diffuse symptoms include swollen and tender glands under the arms, recurrent unexplained low-grade fever, flu like symptoms,hair loss, skin rash, memory loss, headaches, chest pain, and shortness of breath.  A significant, portion of women with silicone implants have reported various connective tissue diseases including fibromyalgia, chronic fatigue syndrome, and carpal tunnel syndrome. Others have reported various autoimmune diseases including systemic lupus, rheumatoid arthritis, and multiple sclerosis. The major studies that have been done on the link between silicone breast implants and autoimmune disease have failed to find a statistically significant increase in disease. However, "not finding" and "not existing" are two different things. There have been general complaints that the studies are funded by the companies that were sued over the effects of implants.

A large portion of the women with these symptoms who have opted to have their silicone implants removed discovered that their symptoms lessened or even disappeared after explantation of the implants by the enbloc method.   Some women had their silicone implants replaced by saline implants, which so far do not appear to be completely devoid of problems either.  Toxic shock syndrome has been reported in connection with saline implants.   An alarming rate of women continue to have other health complaints.

Breast Implants and Health Insurance:

In the U.S., getting breast augmentation surgery -- breast implants for cosmetic reasons -- generally costs between $4,000 and $7,000. Most women have to pay that out of their own pockets. Insurance companies usually will not cover breast enlargement surgery, although they will cover breast implants for women who had mastectomies due to breast cancer.

The upfront costs of breast augmentation surgery aren't the only ones you need to consider. Breast implant surgery may lead to further charges, both in the short and long term. Depending on your insurance, the future costs may also not be covered by insurance. Having breast implants may also affect your insurance rates, your coverage, and even your overall eligibility for health insurance.

Additional Costs of Breast Augmentation Surgery

If you're looking into breast implants for cosmetic reasons, here are some additional costs that you need to consider:

• Additional Charges at the Time of Surgery. Ask your doctor about all the costs -- the implants, the anesthesia, the hospital fees, the medication, and any other charges. Some surgeons include everything in their fee, while others don't.
  
  
• Further Surgeries. Women who get breast implants usually need another surgery at some point. Some women need additional surgery right away if, for example, they have an allergic reaction or want to adjust the position of the implant. Others may need to replace the original implants years later.
  
  Like most medical devices, breast implants don't last forever. Some implant manufacturers offer lifetime guarantees. If the implant breaks, the company will offer a replacement at no cost. However, check the details. The warranty may not include the cost of the surgery or other expenses. Keep in mind that removing breast implants can cost more than putting them in.
  
  
• Diagnostic Testing. The FDA recommends that women with silicone breast implants get an MRI three years after implantation and once every two years after that. This is the only way to make sure the silicone implant hasn't ruptured. (Women with saline implants do not need these tests.)
  MRIs can be expensive. The average cost of an MRI scan in the U.S. is $2,000. 

Because breast implants can interfere with the accuracy of normal mammograms, women may also need extra X-ray images at additional cost. Health insurance probably will not cover these extra diagnostic charges.

Insurance Eligibility and Breast Implants

Some insurance companies consider breast augmentation surgery a "pre-existing condition," and some women who have had breast implants find that they have problems getting health care coverage.

If you have breast implants, an insurance company might:

• Charge higher premiums.
• Limit your coverage. For instance, some insurers won't cover diseases of the breast -- perhaps even breast cancer -- if you have breast implants.
• Deny you coverage altogether.
• Refuse to renew your policy.

The Food and Drug Administration did not regulate medical devices until 1976. Under the 1976 law, devices already in use such as saline-filled breast implants and silicone gel-filled breast implants were "grandfathered". The manufacturers did not have to demonstrate to the F.D.A. that the devices were safe at that time.

Saline-filled breast implants were on the market for nearly three decades in the U.S. before the FDA approved them in May 2000. Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for augmentation in women who are 18 and older. There is no age restriction for saline implants used for reconstruction.

Silicone gel-filled breast implants were removed from the U.S. market in April 1992. Since then the FDA has permitted a small number of women, who wanted silicone gel-filled breast implants for cosmetic purposes and women undergoing mastectomies, to receive the implants in a long-term study. On October 14th and 15th in 2003, the F.D.A. sought input from an Advisory Panel of experts on the data contained in the Inamed pre-market approval (PMA) for silicone gel-filled breast implants during an open public meeting. In a 9-6 vote, the Panel recommended approval of the Inamed PMA with conditions. Ultimately in January 2004, the Food and Drug Administration rejected Inamed Corp.'s bid to bring silicone gel-filled breast implants back on to the market.

Mentor Corporation submitted their silicone gel-filled breast implant PMA in December 2003. The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee reviewed applications submitted by Inamed Corp. and Mentor Corp. for marketing silicone gel-filled breast implants in April 2005. The advisory panel rejected U.S. sales of Inamed Corp.'s silicone gel-filled breast implants by a 5-4 vote. The following day, the Panel voted 7-2 in favor of allowing Mentor's application to be approved.

On Thursday, July 28,2005, the F.D.A. issued an approvable letter for Mentor’s application for silicone gel-filled breast implants. Inamed Corporation received an approvable letter from the Food and Drug Administration (FDA) for its silicone gel-filled breast implants on Sept. 21, 2005. The letters contained information regarding conditions that the companies needed to meet to obtain final FDA approval for marketing the implants in the U.S.

On September 23, 2005 the FDA Commissioner, Lester Crawford, resigned. In October 2006, he pleaded guilty to conflict of interest and falsely reporting information about stocks he owned in food,  beverage and medical device companies that he was in charge of regulating.

On November 17, 2006, the Food and Drug Administration (FDA) issued final approval to manufacturers Allergen Corporation (formerly Inamed) and Mentor Corp. for general marketing of silicone gel-filled breast implants to women of all ages for reconstruction purposes (e.g. cancer & trauma victims or those with breast abnormalities) and women 22 and older for augmentation purposes. The FDA has imposed a minumum age requirement for augmentation because breasts can continue to develop through a woman’s late teens and early twenties and because a young woman may not be mature enough to make a decision about potential risks. The FDA is requiring that Allergen Corporation and Mentor Corp. study 40,000 women for the next 10 years to assess potential health problems. The FDA has also recommended that silicone implant recipients have MRIs at regular intervals to detect ruptures that may be silent.

See Related:

Former FDA Chief Lester Crawford Pleads Guilty in Fraud Case

Escrow Funds Vanish; Inamed Founder Accused of Embezzling Millions

Public Citizen Calls for Criminal Investigation of Breast Implant Manufacturer for Withholding Safety Data from FDA (HRG Publication #1790)

Implant Maker Hid Defects, Workers Said

Dow Corning Tried To Destroy Memos On Dangers Of Implants

FDA Ignoring Requirement for Post-Market Surveillance of Breast Implants

Local Complication and Addition Surgery

Surgeries involving breast implants, whether for cosmetic or reconstructive surgery, carry risk common to many types of surgery. These include adverse reactions to anesthesia, post-operative bleeding (hematoma) or fluid collection (Seroma), surgical site infection or breakdown, breast pain or alterations in sensation or unfavorable scarring, interference with breast feeding, visible wrinkling, asymmetry, thinning of the breast tissue, and symmastia (disruption of the natural plane between breasts which is sometimes referred to as 'bread loafing'). Complications and reoperations related to surgeries with breast implants or tissue expanders can add significant long term costs to patients and health care systems.

Specific complications to indwelling breast implants that have received notable attention involve surveillance and treatment for implant rupture and the phenomena of capsular contracture.

Ruptured Breast Implants can potentially remain intact for decades in the body, but all such devices will fail at some point.  When saline breast implants break, they often deflate quickly and can be easily removed. Prospective studies of saline-filled breast implants showed rupture/deflation rates of 3-5% at 3 years and 7-10% at 5 years for augmentation patients.[

Among the suspected mechanisms for rupture are damage during implantation or other procedures, degradation of the implant shell, blunt or penetrating chest trauma, and in rare instances from the pressure of traditional mammograms.

The age and design of the implant are the most important factors in rupture, but estimating ruptures rates of contemporary devices has been difficult, as most previous reports[mixed heterogeneous groups of devices in non-randomized populations. The only available literature with longer term available MRI data on single lumen 3rd/4th generation silicone implants comes from Europe and has reported silent rupture rates of an implant at between 8% to 15% at or around a decade (or 15-30% of patients).

The first series of MRI evaluation of the highly-cohesive (5th generation) gel implants suggests improved durability, with a rupture rate reported at 1% or less at a median age of six years.

Its been suggested that clinical exams alone are inadequate to evaluate suspected rupture after a study reported that only 30% of ruptures in asymptomatic patients are accurately detected by experienced plastic surgeons, compared to 86% detected by MRIs [The US-FDA has recommended that MRIs be considered to screen for silent rupture starting at three years after implantation and then every two years thereafter. Other countries have not endorsed routine MRI screening, and have taken the position that MRI should be reserved only for cases involving suspected clinical rupture or to confirm mammographic or ultrasound studies suggesting rupture.

When silicone implants break they rarely deflate, and the silicone from the implant can leak out into the space around the implant. An intracapsular rupture can progress to outside of the capsule (extracapsular rupture), and both conditions are generally agreed to indicate the need for removal of the implant. Extracapsular silicone has the potential to migrate, but most clinical complications have appeared to be limited to the breast and axillae in the form of gramiomas   (inflammatory nodules) and axillary lymphadenopathy (enlarged lymph glands in the armpit area). The specific risk and treatment of extracapsular silicone gel is still controversial.

Capsular contracture 

Capsules of tightly-woven collagen fibers form as an immune responce iaround a foreign body (eg. breast implants, pacemakers, orthopedic joint prosthetics), tending to wall it off. Capsular contracture occurs when the capsule tightens and squeezes the implant. This contracture is a complication that can be very painful and distort the appearance of the implanted breast. The exact cause of contracture is not known. However, some factors include bacterial contamination, silicone rupture or leakage, and hematoma. Capsular contracture may happen again after this additional surgery.

Methods which have reduced capsular contracture include submuscular implant placement, using textured or polyurethane-coated implants,  limiting handling of the implants and skin contact prior to insertion and irrigation with triple-antibiotic solutions.

Correction of capsular contracture may require surgical removal or release of the capsule, or removal and possible replacement of the implant itself. Closed capsulotomy (disrupting the capsule via external manipulation), a once common maneuver for treating hard capsules, has been discouraged as it can cause implant rupture. Nonsurgical methods of treating capsules include massage, external ultrasound, treatment with leukotriene pathway inhibitors (Accolate, Singulair),and pulsed electromagnetic field therapy.

Platinum

Platinum is a catalyst  used in the making of silicone implant polymer shells and other silicone devices used in medicine. The literature indicates that small amounts of platinum leaches (leaks) from these implants and is present in the surrounding tissue. The FDA reviewed the available studies from the medical literature on platinum and breast implants in 2002 and concluded there was little evidence suggesting toxicity from platinum in implant patients.

In 2006, researchers published a controversial study that claimed to identify the previously undocumented presence of toxic platinum oxidative states in vivo.  A letter from the editors of the publishing journal, Analytical Chemistry, subsequently expressed concern over the research's experimental design and urged the journal's readers to "use caution in evaluating the conclusions drawn in the paper. The FDA reviewed this study and the existing literature, concluding that the body of existing research did not support their findings, and that the platinum in new implants is likely not ionized and therefore would not represent a significant risk to women.

Cancer screening

The presence of radio-opaque breast implants may interfere with the sensitivity of screening mammography. Specialized radiographic techniques where the implant is manually displaced (Eklund views) may improve this somewhat, but approximately 1/3 of the breast is still not adequately visualized with a resultant increase in false-negative mammograms. A number of studies looking at breast cancers in women with implants have found no significant difference in stage of disease at time of diagnosis, and prognosis appears to be similar in both groups with augmented patients not a higher risk for subsequent cancer recurrence or death. Conversely, the use of implants for reconstruction after mastectomy for breast cancer also appears not to have a negative effect on cancer-related mortality.

An observation that patients with implants are more often diagnosed with palpable tumors (but not larger ones) suggest that tumors of equal size may be more easily palpated in augmented patients, and this may compensate somewhat for the potential impairment of mammography. This palpability is due to thinning of the breast by compression, innately smaller breasts a priori, and that the implant serves as a base against which the mass may be differentiated.

The presence of a breast implant does not influence the ability for breast conservation (lumpectomy) surgery for women who subsequently develop breast cancer, and does not interfere with delivery of external beam radiation (XRT) treatments that may be required. Fibrosis of breast tissue after XRT is common and an increase in capsular contracture rates would be expected.

Repair or revision surgery

Regardless of the type of implant, it is likely that women with implants will need to have one or more additional surgeries (re-operations) over the course of their lives. Breast implants do not last forever. According to studies conducted by implant companies for the U.S. FDA, they sometimes only last a few years. Most common indications for re-operations have included major or minor complications, capsular contracture treatment, and replacement of ruptured/deflated implants. Re-operation rates are predictably more frequent in breast reconstruction cases due to the dramatic changes in the soft-tissue envelope and anatomical breast borders after mastectomy, particularly when patients have received adjuvant XRT.  Breast cancer patients also frequently undergo staged procedures for reconstruction of the nipple-areola complex and symmetry procedures on the opposite breast.