Some interesting American research into implants

The 1994 Mayo Clinic study found that of the 749 subjects studied, no increase in connective tissue disorders was found among those with silicone breast implants. These breast augmentation studies and research, though helpful, were determined to be largely inadequate and inconclusive. The rate of connective tissue diseases in the general population is so low (approximately one in every 100,000) that these studies have been deemed too limited in scope to get an accurate picture of connective tissue risks in women with silicone implants.



Breast augmentation studies and research have also focused on the rupture rates for breast implants. In 1995, professional medical testimony presented to the FDA indicated that breast implant rupture rates were somewhere between five and fifty-one percent, a range too large to determine the real risk of rupture. Breast augmentation studies and research have shown that the risk of rupture increases with the age of the implant, and most patients will experience implant rupture or some other complication requiring additional medical attention within ten years of breast augmentation surgery.



Recent breast augmentation studies and research have focused on silicone breast implants once again. Two major US implant manufacturers have been aggressively pushing for FDA approval on cohesive silicone breast implants which have been banned for 12 years. The company Mentor received conditional approval in July 2005 to begin marketing their implants, while Inamed is still working to gain FDA approval on their silicone implants.



from here

also for saline



Saline breast implants were approved by the FDA in May 2000, even though members of their Advisory Panel expressed shock about the high rate of hardness, pain, additional surgery, and other local complications. The FDA required the manufacturers to keep studying their implants, and the latest results were made public at an FDA meeting on July 9, 2002. After seeing the studies, the FDA’s Advisory Panel again expressed dismay because so many women experienced serious complications, and because safety data are still lacking.

The meeting was requested by the FDA Advisory panel that had recommended FDA approval of saline implants in 2000, under the condition that the companies, Mentor and Inamed (formerly McGhan), conduct long-term safety studies. Both companies provided at least three years of data on complications in 2000 and five years of data on complications at the July 2002 meeting. However, of the more than 1200 women in the Mentor study of breast augmentation patients, only 60 (5 percent!) were analyzed at the five-year follow-up. Physicians, researchers, and the ethicist and consumer representative on the Advisory Panel said an informed choice was impossible for Mentor patients because of the low response rate.



Study Problems
A study of 60 augmentation patients is not large enough to provide useful safety data on breast implants, but the greater problem is that when 95% of the women in a study drop out, nobody knows if those who remain in the study are different than those who don’t. The concern is that women who dropped out of the study may have very different medical problems than those who participated -- whether they are healthier or more ill. Although Mentor subsequently obtained some data for about half of the augmentation patients who were supposed to be in their study, one member of the Advisory panel criticized Mentor for its “mind boggling poor results.” I think that was very kind. As a former faculty member, I can honestly say that if an undergraduate student presented these data to me, I would have flunked them. Approximately half the breast cancer reconstruction patients in the Mentor study were analyzed after five years. Although better than the breast augmentation study, this is still considered a very poor response rate.


Health Problems, Cosmetic Problems, More Surgery, and Other Complications
The study by Inamed (formerly called McGhan) was better designed, but many of the women in the study had serious complications or needed additional surgery. For example, during the first five years of having implants, 45 percent of breast cancer reconstruction patients required additional unplanned surgery, 28 percent had their implants removed, 39 percent had breasts that did not match in appearance, 36 percent had capsular contracture (hardness), 27 percent had implants that were visible or could be felt, and 25 percent had implants that created a wrinkling appearance, 18 percent had implants that had moved to the wrong location, 18 percent had breast pain, and 8 percent had implants that leaked or deflated. The rates of 10 other complications such as infections, skin necrosis (skin death) and implants extruding through the skin ranged from 3 percent to 7 percent each.



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and I mustn't forget the Brits (not a study just good info):

Breast implants


A breast implant consist of an outer shell and a filling material which is most often silicone gel or sometimes salt water (referred to as saline). Some implants are round and others are shaped more like a natural breast referred to as tear drop or anatomical implants. Either can give excellent results. The manufacturers life expectancy of breast implants is 10 or more years, although implants can stay in without problems for a much longer time.

Expectations and complications


Breast augmentation has for many years been the most common cosmetic procedure in the UK which is testimony to its safety and ability to achieve a satisfying outcome in most patients. However no surgical procedure is without risk and understanding these risks as well as having a realistic expectation is essential.

When any foreign material is inserted in the body it makes a protective coating around it which in most women forms a thin membrane that remains undetectable externally. In a few women however the reaction to the implant is greater and this is referred to as a capsule as the membrane becomes much thicker. The capsule around the implant can become thickened and contracted. The newer designs of implants have features to reduce the likelihood of this happening. This problem occurs to some extent in around 5 or 6% of patients and usually starts at about a year after surgery although it may take many years to become noticeable when looking at the chest. This can lead to pain, and/or an abnormally hard feel of the implant in the breast. Treatment may be needed and occasionally removal of the implant. Breast augmentation does not usually interfere in breast feeding, and there is no evidence that any silicone is found in breast milk. The presence of breast implants may interfere in mammography, which is an X-ray screening method for breast cancer. Special X-ray views can be taken to minimize this interference and studies have shown that the sensitivity of detecting a breast cancer in patients who have had implants is not reduced compared to normal women who do not have implants.

Most women have some degree of asymmetry between breasts and breast augmentation may occasionally exaggerate this difference. A breast that has an underlying implant will not necessarily feel like a normal breast, and some women may be acutely aware of the implant as a foreign body within the breast. The size and shape of the breast following breast augmentation surgery will adjust with time and can be unpredictable. It is also not always possible to create a cleavage with breast augmentation. Please remember that the weight of the implant may influence the age-related changes that normally take place in breasts. Movement of the fluid which fills the implant may occasionally be seen through the skin, this being more likely in the saline (salt water) filled implants, and less likely in the more viscous silicone implants, which also have a more natural feel. Breast augmentation will always leave scars on the breast or in the armpit, and although the scars will settle over 12 or more months, the appearance of the scars does vary between different individuals. This scarring is placed in such a position as to minimize visibility even when wearing a swimming costume. Complications that occur with breast augmentation include those associated with all forms of surgery, as well as the specific problems of bleeding and infection. Any infection that may occur in the tissue around the implant can usually be treated with antibiotics, but may require surgical removal of the implant.

Safety of silicone


Whatever the filling of the implant, the outer layer is made of silicone which is a firm type of material referred to as silicone elastomer. Silicon is a naturally occurring element which becomes silicone when it is combined with carbon hydrogen and oxygen. Silicone is manufactured into many items including cosmetics, foods and medical implants. Many studies have been conducted to establish whether silicone breast implants cause certain diseases. As a result of these studies we can say that at present there is no evidence to suggest that silicone breast implants are associated with an increased incidence of breast cancer. There is also no evidence to suggest that these implants cause autoimmune diseases such as rheumatoid arthritis.



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Well I found this very interesting from the MHRA and their independent review group into breast implants

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their recomendations for how surgeons inform their patients are not all done to this day, and this was 1997.

Interesting read babe - thanks for posting. xx

Really interesting hun xx