Breast Implants Are Safe

Breast Implants, in a small number of women, can result in complications that are not life threatening and easily remedied. Some women have had implants for over 25 years and believe they made the right choice. Your complete guide to safety of breast implants.

For years, Tracey Stevens from the UK suffered a mystery illness which left her with joint pain and extreme fatigue. Tests revealed her silicone breast implants had ruptured and the silicone was leaking into her blood. They were made by Poly Implant Prothese, (PIP), a French firm which was the third largest manufacturer of implants before it went into administration at the end of last year, leaving victims struggling to get compensation.

Tracey's cheap implants lacked an inner layer to stop them leaking, in what experts believe was a cost-cutting measure, and they contained a gel probably intended for mattresses which had not had safety tests. Up to 50,000 UK women, including some breast cancer survivors, have implants filled with this gel. So, just how safe are breast implants?

Breast Implants are not lifetime devices

Erica Jefferson from the FDA's Office of Public Affairs says, "Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications. One in 5 patients who receive implants for breast augmentation will need them removed within 10 years of implantation. For patients who receive implants for breast reconstruction, as many as 1 in 2 will require removal 10 years after implantation.

The most frequently observed complications and outcomes are capsular contracture (hardening of the area around the implant), reoperation (additional surgeries) and implant removal. Other common complications include implant rupture, wrinkling, asymmetry, scarring, pain and infection.

The FDA is recommending that women continue to routinely follow up with their health care provider. Erica says, "Get routine MRIs to detect a rupture that you may not be aware of (silent rupture). The agency recommends that women with silicone gel-filled breast implants get screenings for silent ruptures three years after they get implants and every two years after that."

Jennifer Kyne, Press Officer for The Medicines and Healthcare products Regulatory Agency (MHRA) agrees that breast implants are likely to need replacing with consequent further surgery and expense. "A young woman who has implants may expect to have further operations in her lifetime to maintain the beneficial effects of the implants. The length of time a breast implant lasts is unknown and may vary. All women should be informed that their breast implants may need replacing at their first appointment so that they are aware of future costs and potential implications" she says.

Only a very small number of women have complications

Douglas McGeorge, a spokesperson and past president of BAAPS, is a leading plastic and cosmetic surgeon from Cheshire in the United Kingdom. He says that the FDA is always incredibly cautious, and perhaps too much so. "No implant is sold as a permanent cure. However, if you don't have a problem with an implant, it may never need changing. For complications, there is a limitation involved in fitting any foreign body into the body and that is that the body will form a scar around it. On a proportion of people, that scar can tighten as it matures. That is called capsular contracture – stretching of the scar tissue around the implant due to tightening as it matures. This is not so much a complication but a limitation of healing which will occur in up to 5% of people – a very small proportion. And in my practice, it is a lot less than that. People sometimes say, 'my breasts went hard'. This is not a complication but a limitation of healing.

"I always tell my patients that if they have any concerns, to come back and see me. If you develop for instance, capsular contracture, the chances are it will be a few years down the line, so if you are taking out the old scars, it would make sense after a few years has passed to put new implants at the same time. However, capsular contraction is very unusual in my practice and if it happens, I do corrections free of charge, but for most people, it would be a similar price to having new implants.

Douglas is not dismissive of prospective problems, but says that women shouldn't be overly cautious either. "You don't expect a piece of clothing or a car to last forever. It might need some maintenance along the way. You must never consider an implant as something you do once in your life. If you are unfortunate and develop problems, you might have to have something done in the future. Things can change, gravity can stretch the tissues, or drooping can occur."

Implants and screening concerns

Douglas also allays any concerns regarding the possibility of implants complicating screening for breast cancer. He explains, "If you take a standard mammogram which is taken obliquely across the breast, the implant will shadow across the breast tissue, so the machine just needs to be adjusted accordingly. It will then pick up any abnormalities as it would usually. If women are still worried, they can have an MRI scan or ultrasound. Also, bear in mind that since the breast tissue is sitting on top of the implants, you can still examine yourself as you would normally."

However, the MHRA suggests that the presence of silicone gel filled breast implants may interfere with standard mammography as silicone is radiopaque, and the physical presence of the implant may obscure part of the breast tissue and distort breast structure. The Agency says that the amount of interference varies depending on a variety of factors including the position of the implant. However studies indicate that breast cancer in women with breast implants is not diagnosed at a later stage compared with women without implants.

Deposits of calcium containing salts (calcification) are known to occur in the tissue around implants. These deposits are believed to increase with time and may remain once the implant has been removed. Although these calcifications are not considered harmful in themselves, they can be seen on mammograms and may interfere with mammographic findings and interpretation of results. Since calcification may also be

seen in women with breast cancer, further tests (including a biopsy) may be needed to differentiate between calcification due to breast implants or cancer.

To increase sensitivity, a different mammographic technique needs to be used in women with breast implants. It is therefore vital that the centre carrying out the mammography is aware of the presence of breast implants (and the type of implant if known) before the mammography takes place. Mobile breast screening units may not have the necessary facilities for screening women with breast implants and it may therefore be necessary to refer these women to a fixed breast screening unit.

Concern regarding the possibility that the pressures used during mammography might damage the implant should not discourage women from undergoing this procedure. There is only anecdotal information in the literature regarding the breast implant rupture during mammography. The radiographer should however take this potential risk into account when performing the mammography.

Best thing I've ever done

Hanna Johnson's aunt had breast implants in the early eighties and only now needs one replaced. Hanna, 23, a model from Australia, decided to have implants in December last year and says it is 'the best thing I've ever done' although she is aware that implants are not forever. It's early days yet, but she has suffered no complications. "My skin is still a little numb between my nipple and my arm pit but nothing to really worry about," she says. Hanna opted to have her surgery in Malaysia as it was cheaper. She says, "Once I did the research I realised their hospitals were better rated and more up to date with technology than ours. Also, it cost $5000 compared to $10,000 to $15,000 if I'd have them done locally, and I was able to have the surgery right away rather than being put on an 18 month waiting list."

In the UK, the price of implants depends on the chosen manufacturer and the style, but good quality implants generally cost from £600 to £1200, and surgery is around £5000 all inclusive. There are some cheaper implants around, but Poly Implant Prothese is a good example of why not to use a cheap product.

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